(246 days)
Not Found
No
The description focuses on real-time PCR technology and automated interpretation based on predefined criteria (amplification status of target and control), with no mention of AI or ML.
No
This device is an in vitro diagnostic test intended to aid in the diagnosis of gastrointestinal infection by detecting nucleic acids from specific enteric pathogens. It does not provide therapy.
Yes.
The device is described as "an automated in vitro diagnostic test for the direct qualitative detection of enteric pathogens" and is "intended to aid in the diagnosis of gastrointestinal infection."
No
The device description explicitly states that the BD MAX™ System and the BD MAX™ Enteric Parasite Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The BD MAX™ Enteric Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric pathogens."
N/A
Intended Use / Indications for Use
The BD MAX™ Enteric Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from:
• Giardia lamblia
- · Cryptosporidium (C. hominis and C. parvum only)
- Entamoeba histolytica
Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, enteritis or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of specific targets. The test utilizes fluorogenic gene-specific hybridization probes for detection of the amplified DNA.
This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Giardia lamblia, Cryptosporidium hominis and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative results in the ss compatible with gastroenteritis and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
Product codes
PCH, OOI
Device Description
The BD MAX™ System and the BD MAX™ Enteric Parasite Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
0-1 month, 1 month to 2 years, 2-12 years, 13-18 years, 19-21 years, Over 21 years, Unknown
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A total of 2204 prospective specimens (1128 10% formalin-fixed, 1058 unpreserved and 18 noncompliant) and 411 retrospective specimens (148 10% formalin-fixed, 251 unpreserved and 12 noncompliant) were enrolled in the clinical evaluation. Table 19 describes the number of compliant specimens enrolled by patient age and specimen type. A total of 128 retrospective specimens were not included in the performance calculations below as the historical results were not confirmed by an alternate PCR and bi-directional sequencing.
Summary of Performance Studies
Precision:
Within-laboratory precision was evaluated for the BD MAX™ Enteric Bacterial Panel at one (1) site. The Precision panel consisted of 4 sample categories near the LoD. Each specimen contained negative stool matrix. Testing was performed in triplicate, over 12 days, with 2 runs per day, by 2 different technologists.
- For moderate positives (MP): overall correct percentage of approximately 100% with 95% CI
- For low positives (LP): overall correct percentage of approximately 95% with 95% CI
- For true negatives (TN): overall correct percentage of approximately 100% with 95% CI
- For high negatives (HN): overall correct percentage between 20 and 80%
Reproducibility:
For the Site-to-Site reproducibility study, three (3) clinical sites were provided with a total of sixteen (16) panels, each consisting of 12 tubes. The panels used were the same as described under the Precision heading, above. Each site was asked to perform the study on eight (8) distinct days (consecutive or not), wherein each day, two (2) panels were tested, one (1) for each of two (2) technologists. The overall Site-to-Site Reproducibility percent agreement was 100% for the TN and MP categories for all targets, and ranged from 38.2% to 48.6% and 97.2% to 98.6% for the HN and LP categories, respectively.
For the Lot-to-Lot reproducibility study, two users each completed a single run of 12 panel members on a single instrument for each of two lots of reagents over a 5-day period. The panels used were the same as described under the Precision heading, above. Results from 5 days of the accuracy and precision study were used to comprise data for one lot of reagents for the Lot-to-Lot study. The overall Lot-to-Lot reproducibility percent agreement was 100% for the TN and MP categories for all targets, and ranged from 48.9% to 55.6% and 97.8% to 98.9% for the HN, and LP categories, respectively.
Clinical Performance Studies:
A clinical study was designed to assess the performance of the BD MAX Enteric Parasite Panel for the identification of Giardia lamblia, Cryptosporidium parvum/hominis and Entamoeba histolytica, from unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, enteritis and/or colitis. This multicenter study evaluated results obtained with the BD MAX Enteric Parasite Panel compared to those obtained with the reference method. Clinical centers were employed to collect and test patient specimens; whereas collection centers were employed to collect patient specimens, with the reference method and EPP testing being performed off-site.
Sample Size:
2204 prospective specimens and 411 retrospective specimens (2495 compliant specimens in total).
Key Results:
Giardia lamblia:
10% Formalin Fixed Prospective: Sensitivity 95.5%, Specificity 99.7%
10% Formalin Fixed Retrospective: PPA 100.0%, NPA 100.0%
Unpreserved Prospective: Sensitivity 94.4%, Specificity 100.0%
Unpreserved Retrospective: PPA 98.6%, NPA 94.9%
Cryptosporidium parvum/hominis:
10% Formalin Fixed Prospective: Sensitivity 90.3%, Specificity 99.8%
10% Formalin Fixed Retrospective: PPA 93%, NPA 100%
Unpreserved Prospective: Sensitivity 100%, Specificity 99.5%
Unpreserved Retrospective: PPA 97.7%, NPA 98.4%
Entamoeba histolytica:
10% Formalin Fixed Prospective: Specificity 100% (No data for sensitivity calculation as no positive specimens were found)
10% Formalin Fixed Retrospective: NPA 100% (No data for PPA calculation as no positive specimens were found)
Unpreserved Prospective: Specificity 100% (No data for sensitivity calculation as no positive specimens were found)
Unpreserved Retrospective: PPA 100%, NPA 100%
Entamoeba histolytica Contrived Specimen Performance:
Formalin 10%: PPA 100%, NPA 100%
Unpreserved: PPA 100%, NPA 100%
Key Metrics
Sensitivity, Specificity, Positive Percent Agreement (PPA), Negative Percent Agreement (NPA). Numerical values are listed in the "Summary of Performance Studies" section.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
BECTON, DICKINSON AND COMPANY PAUL SWIFT REGULATORY AFFAIRS MANAGER 7 LOVETON CIR. SPARKS MD 21152
Re: K143648
Trade/Device Name: BD Max Enteric Parasite Panel, BD Max Instrument Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal microorganism multiplex nucleic acid based assay Regulatory Class: II Product Code: PCH, OOI Dated: July 30, 2015 Received: July 31, 2015
Dear Mr. Swift:
This letter corrects our substantially equivalent letter of August 25, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809 ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143648
Device Name BD MAX™ Enteric Parasite Panel
Indications for Use (Describe)
The BD MAX™ Enteric Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from:
• Giardia lamblia
- · Cryptosporidium (C. hominis and C. parvum only)
- Entamoeba histolytica
Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, enteritis or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of specific targets. The test utilizes fluorogenic gene-specific hybridization probes for detection of the amplified DNA.
This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Giardia lamblia, Cryptosporidium hominis and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative results in the ss compatible with gastroenteritis and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
BD MAX Enteric Parasite Panel (EPP)
Summary Preparation Date:
August 18, 2015
Submitted by:
BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152
Contact:
Paul Swift, RAC Regulatory Affairs Manager
Tel: 410-316-4905 Fax: 410-316-4188 Email: Paul_Swift@bd.com
Proprietary Names:
For the instrument:
BD MAX™M
For the assay:
BD MAX™ Enteric Parasite Panel (EPP)
Common Names:
For the instrument: Bench-top molecular diagnostics workstation
For the assay:
Enteric Parasite Nucleic Acid Test Enteric Parasite identification and differentiation system Enteric assay Enteric test
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Regulatory Information
Regulation section:
- 3990 - Gastrointestinal microorganism multiplex nucleic acid-based assay
Classification:
Class II
Panel:
Microbiology (83)
Product Code(s):
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Predicate Device
FilmArray Gastrointestinal (GI) Panel Kit [K140407 (May 2, 2014)], BioFire Diagnostics, LLC
Device Establishment
GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. du Parc-Technologique Quebec, QC G1P 4S5 Canada
Registration Number: 3007420875
Performance standards
No performance standards have been developed under Section 514 of the Food, Drug and Cosmetic Act.
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Intended Use
The BD MAX™ Enteric Parasite Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection of enteric pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from:
- Giardia lamblia
- Cryptosporidium (C. hominis and C. parvum only)
- . Entamoeba histolytica
Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of specific targets. The test utilizes fluorogenic gene-specific hybridization probes for detection of the amplified DNA.
This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Giardia lamblia. Cryptosporidium hominis and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis and/or colitis may be due to infection by pathogens that are not detected by this test or noninfectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
| Special Conditions for Use Statement: | For prescription use |
|---|---|
| Special Instrument Requirements: | BD MAX™ System |
Device Description
The BD MAX™ System and the BD MAX™ Enteric Parasite Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.
Test Principle
Stool specimens are collected from patients and transported to the laboratory either unpreserved in a clean container or 10% formalin-fixed. The specimen is vortexed and a 10 uL loop is inserted to the depth of the loop into the specimen, and expressed using a swirling motion into a BD MAX Sample Buffer Tube (SBT). The SBT is closed with a septum cap and then heated on the BD Pre-Warm Heater to facilitate
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lysis of the parasite organisms. The SBT is then vortexed and transferred to the BD MAX System. Once the work list is generated and the clinical sample is loaded on the BD MAX instrument with a EPP Unitized Reagent Strip (URS) and PCR Cartridge, the run is started and no further operator intervention is required. The BD MAX System automates sample preparation, including target organism lysis, DNA extraction and concentration, reagent rehydration, target nucleic acid sequence amplification and detection using real-time PCR. The interpretation of the signal is performed automatically by the BD MAX System. The assay also includes a Sample Processing Control (SPC) that is provided in the Extraction Tube and subjected to extraction, concentration and amplification steps. The SPC is incorporated into the lysis, extraction and amplification steps to monitor for the presence of potential inhibitory substances as well as system or reagent failures.
Following enzymatic cell lysis at an elevated temperature, the released nucleic acids are captured on magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids are eluted by heat and high pH in Elution Buffer. Eluted DNA is pH neutralized and transferred to the Master Mix Tube to rehydrate the PCR reagents. After rehydration, the BD MAX System dispenses a fixed volume of DNA eluent into the BD MAX PCR Cartridge. Microvalves in the BD MAX PCR Cartridge are sealed by the system prior to initiating PCR to contain the amplification mixture thus preventing heat evaporation and contamination. The amplified DNA targets are detected using hydrolysis (TagMan") probes, labeled at one end with a fluorescent reporter dye (fluorophore) and at the other end with a quencher moiety. Probes labeled with different fluorophores are used to detect amplicons for enteric parasite targets and the Sample Processing Control in four different optical channels of the BD MAX System: Giardia lamblia target amplicons are detected in the FAM channel, Cryptosporidium parvum/hominis target amplicons are detected in the ROX channel, Entamoeba histolytica target amplicons are detected in the VIC channel and Sample Processing Control amplicons are detected in the Cy5.5 channel.When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target DNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5'-3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the DNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD MAX System monitors these signals at each cycle and interprets the data at the end of the program to report the final results.
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Substantial Equivalence1
Table 1 shows the similarities and differences between the BD MAX Enteric Parasite Panel and the predicate device.
| Table 1: Comparison to Predicate Device | ||
|---|---|---|
| ITEM | BD MAX Enteric Parasite Panel | FilmArray Gastrointestinal (GI) Panel Kit |
| [K140407 (May 2, 2014)] | ||
| BioFire Diagnostics, LLC | ||
| Specimen type | Unpreserved and 10% formalin-fixed stool. | Human stool samples collected in Cary Blair transport media. |
| Assay Format | Amplification: PCR | |
| Detection: fluorogenic target-specific hybridization. | Nested multiplex RT-PCR followed by high resolution melting analysis to confirm identity of amplified product. | |
| Interpretation of Test Results | Automated (BD MAX System diagnostic software) | Automated test interpretation and report generation by the FilmArray™ Instrument. |
| Analysis Platform | BD MAX System | FilmArray™ Instrument |
| PCR Sample Preparation | Automated by the BD MAX System | Automated by the FilmArray™ Instrument |
| Detection Probes | TaqMan® Probe | Unknown - information not available publicly |
| Assay Controls | Sample Processing Control (SPC) | Two controls are included in each reagent pouch to control for sample processing and both stages of PCR and melt analysis |
Таы» 1. С. to Predicate Da
1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
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Analytical Performance
Precision
Within-laboratory precision was evaluated for the BD MAX™ Enteric Bacterial Panel at one (1) site. The Precision panel consisted of 4 sample categories near the LoD. Each specimen contained negative stool matrix. Target strains were tested as follows:
- For moderate positives (MP): overall correct percentage of approximately 100% with 95% CI
- . For low positives (LP): overall correct percentage of approximately 95% with 95% CI
- . For true negatives (TN): overall correct percentage of approximately 100% with 95% CI
- For high negatives (HN): overall correct percentage between 20 and 80% ●
Testing was performed in triplicate, over 12 days, with 2 runs per day, by 2 different technologists. Precision study results are summarized below in Table 2.
| Panel Member Level | Specimen/Target | Percentage Correct (%) |
|---|---|---|
| High Negative (HN) | G. lamblia | 48.6 |
| C. parvum | 41.7 | |
| E. histolytica | 37.5 | |
| Low Positive (LP) | G. lamblia | 98.6 |
| C. parvum | 98.6 | |
| E. histolytica | 98.6 | |
| Moderate Positive (MP) | ALL | 100 |
| True Negative (TN) | ALL | 100 |
Table 2: Within-laboratory Precision Testing
Reproducibility
For the Site-to-Site reproducibility study, three (3) clinical sites were provided with a total of sixteen (16) panels, each consisting of 12 tubes. The panels used were the same as described under the Precision heading, above. Each site was asked to perform the study on eight (8) distinct days (consecutive or not), wherein each day, two (2) panels were tested, one (1) for each of two (2) technologists.
The overall Site-to-Site Reproducibility percent agreement was 100% for the TN and MP categories for all targets, and ranged from 38.2% to 48.6% and 97.2% to 98.6% for the HN and LP categories, respectively (Table 3). The qualitative and quantitative reproducibility across sites and by target is presented below in Tables 4 through 9. Ct.Score is an internal criterion used to determine final assay results and was selected as an additional means of assessing assay
9
reproducibility. Overall mean Ct.Score values with variance components (SD and %CV) are shown in Tables 5, 7 and 9.
| Category | Giardia lamblia | Cryptosporidium parvum | Entamoeba histolytica |
|---|---|---|---|
| TN | 100.0% (144/144) | ||
| (97.4%, 100.0%) | 100.0% (144/144) | ||
| (97.4%, 100.0%) | 100.0% (144/144) | ||
| (97.4%, 100.0%) | |||
| HN | 48.6% (70/144) | ||
| (40.6%, 56.7%) | 38.2% (55/144) | ||
| (30.7%, 46.3%) | 47.2% (68/144) | ||
| (39.2%, 55.3%) | |||
| LP | 97.2% (140/144) | ||
| (93.1%, 98.9%) | 97.2% (140/144) | ||
| (93.1%, 98.9%) | 98.6% (142/144) | ||
| (95.1%, 99.6%) | |||
| MP | 100.0% (144/144) | ||
| (97.4%, 100.0%) | 100.0% (144/144) | ||
| (97.4%, 100.0%) | 100.0% (144/144) | ||
| (97.4%, 100.0%) |
Table 3: Site-to-Site Reproducibility Study Results using one lot of the BD MAX Enteric Parasite Panel
Table 4: G. lamblia Site-to-Site Qualitative Reproducibility Across Sites with Pooled Days, Runs and Replicates
| Category | X LoD | SITE | Total | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CIN | CLE | BD NC | Correct | Incorrect | |||||||||||||
| Correct | Incorrect | Correct | Incorrect | Correct | Incorrect | n | % | n | % | ||||||||
| TN | 0 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 144 | 100.0 | 0 | 0 |
| HN | 0.1-0.5 | 23 | 47.9 | 25 | 52.1 | 22 | 45.8 | 26 | 54.2 | 25 | 52.1 | 23 | 47.9 | 70 | 48.6 | 74 | 51.4 |
| LP | 0.8-1.2 | 46 | 95.8 | 2 | 4.2 | 47 | 97.9 | 1 | 2.1 | 47 | 97.9 | 1 | 2.1 | 140 | 97.2 | 4 | 2.8 |
| MP | 3-5 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 144 | 100.0 | 0 | 0 |
Table 5: G. lamblia Site-to-Site Quantitative Reproducibility Across Sites, Days, Runs and Within Run
| Ct.score | Within Run | Between Run within Day | Between Day within Site | Between Site | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Category | n | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| HN | 74 | 31.2 | 1.17 | 3.7% | 0.55 | 1.8% | 0.56 | 1.8% | 0.00 | 0.0% | 1.41 | 4.5% |
| LP | 140 | 28.7 | 0.78 | 2.7% | 0.00 | 0.0% | 0.00 | 0.0% | 0.37 | 1.3% | 0.86 | 3.0% |
| MP | 144 | 26.8 | 0.44 | 1.6% | 0.15 | 0.6% | 0.00 | 0.0% | 0.15 | 0.6% | 0.49 | 1.8% |
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| Table 6: | C. parvum Site-to-Site Qualitative Reproducibility Across Sites
with Pooled Days, Runs, and Replicates |
| ---------- | ------------------------------------------------------------------------------------------------------------------ |
|---|
| X LoD | SITE | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CIN | CLE | BD NC | Total | |||||||||||||||
| Category | Correct | Incorrect | Correct | Incorrect | Correct | Incorrect | Correct | Incorrect | ||||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | |||
| TN | 0 | 48 | 100.0 | 0 | 0 | 48 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 144 | 100.0 | 0 | 0 | ||
| HN | 0.1-0.5 | 17 | 35.4 | 31 | 64.6 18 | 37.5 | 30 | 62.5 | 20 | 41.7 | 28 | 58.3 | રેર | 38.2 | 89 | 61.8 | ||
| LP | 0.8-1.2 | 46 | 95.8 | 2 | 4.2 | 47 | 97.9 | 1 | 2.1 | 47 | 97.9 | 1 | 2.1 | 140 | 97.2 | ব | 2.8 | |
| MP | 3-2 | 48 | 100.0 | 0 | 0 | 48 100.0 | 0 | 0 | 48 100.0 | 0 | 0 | 144 | 100.0 | 0 | 0 |
Table 7: C. parvum Site-to-Site Quantitative Reproducibility Across Sites, Days, Runs and Within Run
| Ct.score | | | | Within
Run | | Between Run within
Day | Between Day within
Site | | Between Site | Overall | | |
|----------|-----|------|------|---------------|------|---------------------------|----------------------------|------|--------------|---------|------|------|
| Category | n | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| HN | 89 | 35.7 | 1.53 | 4.3% | 0.54 | 1.5% | 0.60 | 1.7% | 0.43 | 1.2% | 1.78 | 5.0% |
| LP | 140 | 31.4 | 1.07 | 3.4% | 0.41 | 1.3% | 0.00 | 0.0% | 0.11 | 0.3% | 1.15 | 3.7% |
| MP | 144 | 30.1 | 0.74 | 2.4% | 0.44 | 1.5% | 0.00 | 0.0% | 0.17 | 0.6% | 0.88 | 2.9% |
Table 8: E. histolytica Site-to-Site Qualitative Reproducibility Across Sites with Pooled Days, Runs and Replicates
| Category | X LoD | SITE | Total | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CIN | CLE | BD NC | Correct | Incorrect | |||||||||||||
| Correct | Incorrect | Correct | Incorrect | Correct | Incorrect | n | % | n | % | ||||||||
| TN | 0 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 144 | 100.0 | 0 | 0 |
| HN | 0.1-0.5 | 22 | 45.8 | 26 | 54.2 | 26 | 54.2 | 22 | 45.8 | 20 | 41.7 | 28 | 58.3 | 68 | 47.2 | 76 | 52.8 |
| LP | 0.8-1.2 | 47 | 97.9 | 1 | 2.1 | 47 | 97.9 | 1 | 2.1 | 48 | 100.0 | 0 | 0 | 142 | 98.6 | 2 | 1.4 |
| MP | 3-5 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 48 | 100.0 | 0 | 0 | 144 | 100.0 | 0 | 0 |
11
| Ct.score | Within Run | Between Run within Day | Between Day within Site | Between Site | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Category | n | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||
| HN | 76 | 30.4 | 2.34 | 7.7% | 1.35 | 4.4% | 0.66 | 2.2% | 0.32 | 1.0% | 2.80 | 9.2% |
| LP | 142 | 25.5 | 0.88 | 3.4% | 0.26 | 1.0% | 0.00 | 0.0% | 0.00 | 0.0% | 0.91 | 3.6% |
| MP | 144 | 23.5 | 0.58 | 2.5% | 0.37 | 1.6% | 0.00 | 0.0% | 0.09 | 0.4% | 0.69 | 2.9% |
Table 9: E. histolytica Site-to-Site Quantitative Reproducibility Across Sites, Days, Runs and Within Run
For the Lot-to-Lot reproducibility study, two users each completed a single run of 12 panel members on a single instrument for each of two lots of reagents over a 5-day period. The panels used were the same as described under the Precision heading, above. Results from 5 days of the accuracy and precision study were used to comprise data for one lot of reagents for the Lot-to-Lot study.
The overall Lot-to-Lot reproducibility percent agreement was 100% for the TN and MP categories for all targets, and ranged from 48.9% to 55.6% and 97.8% to 98.9% for the HN, and :LP categories, respectively (Table 10).
12
| 95% CI | ||||||
|---|---|---|---|---|---|---|
| Target | Level | Correct | Total | % Correct | LowerCI | UpperCI |
| TN** | 90 | 90 | 100.0% | 95.9% | 100.0% | |
| G. lamblia | HN* | 44 | 90 | 48.9% | 38.8% | 59.0% |
| LP | 88 | 90 | 97.8% | 92.3% | 99.4% | |
| MP | 90 | 90 | 100.0% | 95.9% | 100.0% | |
| C. parvum | TN | 90 | 90 | 100.0% | 95.9% | 100.0% |
| HN | 50 | 90 | 55.6% | 45.3% | 65.4% | |
| LP | 88 | 90 | 97.8% | 92.3% | 99.4% | |
| MP | 90 | 90 | 100.0% | 95.9% | 100.0% | |
| E. histolytica | TN | 90 | 90 | 100.0% | 95.9% | 100.0% |
| HN | વર્સ | 90 | 50.0% | 39.9% | 60.1% | |
| LP | 89 | 90 | 98.9% | 94.0% | 99.8% | |
| MP | 90 | 90 | 100.0% | 95.9% | 100.0% |
Table 10: Lot-to-Lot Reproducibility - Study Results using three lots of the BD MAX Enteric Parasite Panel
- HNs are dilutions of the LoD designed to produce results that are negative for 20% to 80% of replicates. As such, "% Correct" correlates to the percent of negative results.
** TNs were blanks, therefore, "% Correct" correlates to the percent of negative results.
Sample Storage
Collected specimens, either unpreserved or 10% formalin fixed stool, should be kept between 2 °C and 25 °C during transport. Protect against freezing or exposure to excessive heat.
Specimens, either unpreserved or 10% formalin fixed stool, can be stored for up to 120 hours (5 days) at 2-8 ℃ or for a maximum of 48 hours at 2-25 ℃ before testing.
Prior to or following pre-warm, inoculated Sample Buffer Tubes can be stored for testing) for a total of up to:
| Time | Temperature |
|---|---|
| 120 hours (5 days) | 2 - 8 °C |
| 48 hours | 2 - 25 °C |
Controls
External Control materials are not provided by BD; however, Quality Control strains and procedures are included in the package insert. Various types of External Controls are recommended to allow the user to select the most appropriate for their laboratory quality control program:
13
- Commercially available positive control materials
- Giardia intestinalis (Lambl) (ATCC 3088D)
- Cryptosporidium parvum (ATCC PRA-67D) —
- Entamoeba histolytica (ATCC 30459D)
- External negative control —
- Use a non-inoculated BD MAX™ Enteric Parasite Panel SBT —
The assay includes a Specimen Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances.
Analytical Sensitivity
The analytical sensitivity (Limit of Detection or LoD) for the BD MAX Enteric Parasite Panel was determined for each assay target individually. Purified organisms were used to prepare targets that were inoculated into the Sample Buffer Tube along with pooled negative stool matrix (both unpreserved and 10% formalin fixed were evaluated, separately). The pooled negative stool matrix was created from stool specimens obtained from patients that were characterized by the BD MAX Enteric Parasite Panel. The organism concentrations were used to simulate positive samples with a wide range of organism loads. The LoD was determined for each organism tested with both unpreserved and 10% formalin fixed targetnegative stool matrix. The results from the LoD study can be found below in Table 11.
14
T
| | Unpreserved
[95% Confidence Interval] | 10% formalin fixed
[95% Confidence Interval] |
|------------------------------------------------------------|------------------------------------------|-------------------------------------------------|
| Cryptosporidium parvum | | |
| LoD
(organism/mL in SBT)
[95% confidence interval] | 160.17 [96.93 - 264.22] | 154.25 [100.46 - 236.57] |
| LoD
(organism/mL in stool)
[95% confidence interval] | 24,026 [14,540 - 39,633] | 92,550 [60,276 - 141,942] |
| Giardia lamblia | | |
| LoD
(organism/mL in SBT)
[95% confidence interval] | 10.67 [5.69 - 15.66] | 10.04 [4.83 - 15.25] |
| LoD
(organism/mL in stool)
[95% confidence interval] | 1,601 [854 - 2,349] | 6,024 [2,898 - 9,150] |
| Entamoeba histolytica | | |
| LoD
(organism/mL in SBT)
[95% confidence interval] | 16.79 [11.97 - 23.42] | 15.52 [10.99 - 21.76] |
| LoD
(organism/mL in stool)
[95% confidence interval] | 2,519 [1,796 - 3,570] | 9,300 [6,600 - 13,080] |
Table 11: BD MAX Enteric Parasite Panel Target Limits of Detection
Analytical Inclusivity
The objective of this study was to demonstrate that the BD MAX Enteric Parasite Panel is able to detect clinically relevant and geographically diverse serovars/strains/ subspecies for each of the BD MAX™ Enteric Parasite Panel targets found in various geographical origins. The study was designed to validate the functional performance of the BD MAX™ Enteric Parasite Panel by verifying the specificity of the assay's primers and probes for the targeted bacterial enteric analytes.
In total, eleven (11) distinct strains/isolates of whole organisms of Giardia lamblia/intestinalis, ten (10) distinct strains/isolates of whole organisms of Entamoeba histolytica and one (1) strain of Cryptosporidium hominis whole organism were screened with the BD MAX Enteric Parasite Panel at 2X the point estimate of the 95% LoD (Table 12). One genomic DNA preparation, representative of each BD MAX Enteric Parasite Panel target, was screened at 2X LoD (Table 13).
Due to the lack of availability of Cryptosporidium parvum/hominis organisms, commercially available genomic DNA libraries, prepared from nine (9) distinct Cryptosporidium parvum strains/isolates, were also evaluated as supplementary information.
15
An additional study was performed for Cryptosporidium due to the lack of commercially available organisms. DNA extracts from thirteen (13) clinical stool specimens with known Cryptosporidium spp. infection status, were obtained (Table 14). Because it is not possible to discriminate human or other DNA from parasite DNA by spectrophotometry, quantification of the DNA extracts was not performed. Instead, Sample Buffer Tubes were spiked with 10 uL of negative, pooled stool matrix and with 5 uL of the clinical specimen DNA extract, in duplicate.
| Organism | ATCC ID | Organism | ATCC ID |
|---|---|---|---|
| Giardia lamblia | PRA-242 | Entamoeba histolytica | PRA-358 |
| Giardia lamblia | PRA-244 | Entamoeba histolytica | 50007 |
| Giardia lamblia | PRA-247 | Entamoeba histolytica | 30890 |
| Giardia lamblia | PRA-249 | Entamoeba histolytica | 30889 |
| Giardia lamblia | 30888 | Entamoeba histolytica | 30458 |
| Giardia intestinalis | 30957 | Entamoeba histolytica | 30459 |
| Giardia intestinalis | 50114 | Entamoeba histolytica | PRA-357 |
| Giardia intestinalis | 50137 | Entamoeba histolytica | 50738 |
| Giardia intestinalis | 50581 | Entamoeba histolytica | 30190 |
| Giardia intestinalis | 50584 | Entamoeba histolytica | 50541 |
| Giardia intestinalis | 50585 | Cryptosporidium parvum | 502 (Tufts) |
| Table 12: Inclusivity Organisms | ||||
|---|---|---|---|---|
| --------------------------------- | -- | -- | -- | -- |
Table 13: Target Genomic DNA
| Organism | Genomic DNA
ATCC ID |
|------------------------|------------------------|
| Cryptosporidium parvum | PRA-67D |
| Giardia lamblia | 30888D |
| Entamoeba histolytica | 30459D |
16
| Organism | Subtype | Organism | Subtype |
|---|---|---|---|
| Cryptosporidium hominis | IbA10G2 | Cryptosporidium parvum | Unknown |
| Cryptosporidium hominis | IbA10G2 | Cryptosporidium parvum | Unknown |
| Cryptosporidium hominis | Unknown | Cryptosporidium parvum | Unknown |
| Cryptosporidium hominis | IbA10G2 | Cryptosporidium hominis | IeA11G3T3 |
| Cryptosporidium hominis | IbA10G2 | Cryptosporidium hominis | IbA10G2 |
| Cryptosporidium hominis | IbA10G2 | Cryptosporidium ubiquitum* | Unknown |
| Cryptosporidium hominis | Unknown |
| Table 14: Clinical Specimen DNA Extracts: Cryptosporidium spp. Positive | ||
|---|---|---|
| ------------------------------------------------------------------------- | -- | -- |
Analytical Specificity
The BD MAX Enteric Parasite Panel was performed on samples containing phylogenetically related species and other organisms (bacteria, viruses, parasites and yeast) likely to be found in stool specimens. Potentially cross-reacting organisms are summarized in Tables 15 - 17.
- Six (6) out of 6 Entamoeba species other than E. histolytica) produced negative ● results with the BD MAX Enteric Parasite Panel. The organisms were tested directly from stock at a 1:10 dilution to obtain the highest possible concentration in the Sample Buffer Tube, with concentrations ranging from 4.00x103 organisms/mL to 2.90x103 organisms/mL in the Sample Buffer Tube. E. barretti (ATCC 30996) was provided as non-titered stock.
- . One (1) out of 1 Cryptosporidium meleagridis strain tested at a concentration ≥ 1x10 ° cycts/mL in the Sample Buffer Tube, produced positive results with the BD MAX Enteric Parasite Panel. Cryptosporidium meleagridis has been documented in symptomatic human infection.
- . One hundred thirteen (113) out of 113 bacterial strains, tested at a concentration > 1x10 CFU/mL in the Sample Buffer Tube, produced negative results with the BD MAX Enteric Parasite Panel.
- Fifteen (15) out of 15 viruses, produced negative results with the BD MAX Enteric Parasite . Panel. Thirteen (13) were tested directly from stock at a 1:10 dilution to obtain the highest possible concentration in the Sample Buffer Tube, with concentrations ranging from 1.6x100 TCID50 - 8.9x10' TCID50 Human Papillomavirus was tested as plasmid in Escherichia coli and Rotavirus was tested as a high titer qualitative standard.
- . Five (5) out of 5 phylogenetically unrelated parasites, tested at a concentration ≥ 1x10 organisms/mL in the Sample Buffer Tube, produced negative results with the BD MAX Enteric Parasite Panel.
- Two (2) out of 2 Candida spp. tested at a concentration > 1x10° organisms/mL in the Sample Buffer Tube, produced negative results with the BD MAX Enteric Parasite Panel.
- Three (3) enteric organisms representing each target of the BD MAX Enteric Parasite Panel were tested, with results as follows:
- One (1) of 1 Cryptosporidium spp.; Cryptosporidium parvum tested at a concentration ≥ O 1x10 cycts/mL in the Sample Buffer Tube, produced positive results for Cryptosporidium and negative results for all other targets with the BD MAX Enteric Parasite Panel.
17
- o One (1) of 1 Giardia spp.; Giardia lamblia tested at a concentration ≥ 1x10° cycts/mL in the Sample Buffer Tube, produced positive results for Giardia and negative results for all other targets with the BD MAX Enteric Parasite Panel.
- One (1) of 1 Entamoeba spp.; Entamoeba histolytica tested at a concentration ≥ 1x10 O cycts/mL in the Sample Buffer Tube, produced positive results for Entamoeba and negative results for all other targets with the BD MAX Enteric Parasite Panel.
18
| Table 15: | |
|---|---|
Potential Cross-Reactant Bacteria and Yeast
| Genus | Species | Strain | |||
|---|---|---|---|---|---|
| Abiotrophia | defectiva | ATCC 49176 | |||
| Acinetobacter | baumannii | ATCC 19606 | |||
| Iwoffii | ATCC 17925 | ||||
| Aeromonas | hydrophila | ATCC 49847 | |||
| Alcaligenes | faecalis subsp. faecalis | ATCC 8750 | |||
| Anaerococcus | tetradius | ATCC 35098 | |||
| Arcobacter | butzleri | ATCC 49616 | |||
| Arcobacter | cryaerophilus | ATCC 43157 | |||
| Bacillus | cereus | ATCC 49064 | |||
| Bacteroides | caccae | ATCC 43185 | |||
| merdae | ATCC 43184 | ||||
| stercoris | ATCC 43183 | ||||
| Bifidobacterium | adolescentis | ATCC 15706 | |||
| longum | ATCC 15707 | ||||
| coli | ATCC 43134 | ||||
| Camplylobacter | concisus | CCUG 17580 | |||
| curvus | CCUG 47528 | ||||
| fetus subsp. fetus | ATCC 27374 | ||||
| fetus subsp. venerealis | ATCC 19438 | ||||
| gracilis | ATCC 33236 | ||||
| hominis | ATCC BAA-381 | ||||
| jejuni | ATCC 43429 | ||||
| Camplylobacter | lari | ATCC 43675 | |||
| Camplylobacter | rectus | ATCC 33238 | |||
| Camplylobacter | upsaliensis | ATCC 49815 | |||
| Candida | albicans | ATCC 24433 | |||
| catenulate | ATCC 18821 | ||||
| Cedecea | davisae | ATCC 33431 | |||
| Chlamydia | trachomatis | ATCC VR-879 | |||
| Citrobacter | amalonaticus | ATCC 25405 | |||
| fruendiib | ATCC 33128 | ||||
| koseri | ATCC 27156 | ||||
| sedlakii | ATCC 51115 | ||||
| Clostridium | difficile | ATCC 17858 | |||
| ATCC 43598 | |||||
| CCUG 8864- ATCC 9689 | |||||
| ATCC 43255 | |||||
| ATCC BAA-1805 | |||||
| ATCC 43593 | |||||
| Clostridium | perfringens | ATCC 10543 | |||
| Collinsella | aerofaciens | ATCC 35085 | |||
| Corynebacterium | genitalium | ATCC 33030 | |||
| Desulfovibrio | piger | ATCC 29098 | |||
| Edwardsiella | tarda | ATCC 15947 | |||
| Eggerthella | lenta | ATCC 25559 | |||
| Enterobacter | aerogenes | ATCC 13048 | |||
| cloacaeb | ATCC 35030 | ||||
| Enterobacter | casseliflavus | ATCC 49605 | |||
| Enterobacter | cecorum | ATCC 43198 | |||
| Enterobacter | dispar | ATCC 51266 | |||
| Enterobacter | faecalis | ATCC 29212 | |||
| Enterobacter | gallinarum | ATCC 49573 | |||
| Enterobacter | hirae | ATCC 49612 | |||
| Enterobacter | raffinosus | ATCC 49427 | |||
| Escherichia | coli | ATCC 25922 | |||
| coli O157 stx 1 | BD RD012313-01 | ||||
| Escherichia | coli O157 stx 2 | coli O157 stx 2 | BD K092012-01 | BD RD092612-01 | |
| Genus | Species | Strain | |||
| Escherichia | coli | ATCC 12014 | |||
| ATCC 8739 | |||||
| ATCC 10536 | |||||
| ATCC 33605 | |||||
| Fusobacterium | fergusonii | ATCC 35469 | |||
| hermannii | ATCC 33650 | ||||
| vulneris | ATCC 33821 | ||||
| Gardnerella | varium | ATCC 27725 | |||
| Gemella | vaginalis | ATCC 14019 | |||
| Hafnia | morbillorum | ATCC 27824 | |||
| Helicobacter | alvei | ATCC 11604 | |||
| fennelliae | ATCC 35683 | ||||
| Klebsiella | pylori | ATCC 43504 | |||
| oxytoca | ATCC 13182 | ||||
| Lactobacillus | pneumoniae | ATCC 33495 | |||
| acidophilus | ATCC 4355 | ||||
| Lactococcus | reuteri | ATCC 23272 | |||
| lactis | ATCC 15346 | ||||
| ATCC 49032 | |||||
| Leminorella | grimontii | ATCC 33999 | |||
| grayi | ATCC 19120 | ||||
| Listeria | innocua | ATCC 33090 | |||
| monocytogenes | ATCC 19115 | ||||
| morganii | ATCC 25830 | ||||
| Morganella | asaccharolyticus | ATCC 14963 | |||
| Peptoniphilus | anaerobius | ATCC 27337 | |||
| Peptostreptococcus | shigelloides | ATCC 14029 | |||
| Plesiomonas | asaccharolytica | ATCC 25260 | |||
| Porphyromonas | melaninogenica | ATCC 25845 | |||
| Proteus | mirabilis | ATCC 29906 | |||
| penneri | ATCC 35198 | ||||
| vulgaris | ATCC 13315 | ||||
| Providencia | alcalifaciens | ATCC 27971 | |||
| rettgeri | ATCC 29944 | ||||
| stuartii | ATCC 33672 | ||||
| Pseudomonas | aeruginosa | ATCC 27853 | |||
| fluorescens | ATCC 13525 | ||||
| Ruminococcus | bromii | ATCC 27255 | |||
| Salmonella | typhimurium | ATCC 14028 | |||
| enteriditis | ATCC 13076 | ||||
| Serratia | liquefaciens | ATCC 35551 | |||
| marcescens | ATCC 13880 | ||||
| Shigella | sonnei | BD ENF 7142 | |||
| flexneri | ATCC 700930 | ||||
| Staphylococcus | aureus | ATCC 25923 | |||
| epidermidis | ATCC 12228 | ||||
| Stenotrophomonas | maltophilia | ATCC 13637 | |||
| Streptococcus | agalactiae | ATCC 13813 | |||
| dysgalactiae | ATCC 43078 | ||||
| intermedius | ATCC 27335 | ||||
| Trabulsiella | uberis | ATCC 19436 | |||
| Veillonella | guamensis | ATCC 49490 | |||
| Vibrio | parvula | ATCC 10790 | |||
| cholerae | BD ENF 13503 | ||||
| Yersinia | parahaemolyticus | bercovieri | ATCC 17802 | ATCC 43970 | |
| enterocolitica | ATCC 9610 | ||||
| rohdei | ATCC 43380 |
19
| Virus | Strain |
|---|---|
| Adenovirus type 2 | ATCC VR-680 |
| Adenovirus type 14 | ATCC VR-15 |
| Adenovirus type 40 | ATCC VR-931 |
| Adenovirus type 41 | ATCC VR-930 |
| Coxsackie A9 | ATCC VR-186 |
| Coxsackie B1 | ATCC VR-687 |
| HHV-5 Cytomegalovirus | ATCC VR-538 |
| Enterovirus type 69 | ATCC VR-785 |
| Human Papillomavirus Type 16 | ATCC 45113 |
| Human Papillomavirus Type 18 | ATCC 45152 |
| Herpes Simplex Virus I | ATCC VR-539 |
| Herpes Simplex Virus II | ATCC VR-734 |
| Norovirus I | 0810086CF |
| Norovirus II | 0810087CF |
| Rotavirus | NATROTA |
Table 16: Potential Cross-Reactant Viruses
Potential Cross-Reactant Parasites Table 171:
| Parasite | Strain |
|---|---|
| Blastocystis hominis | ATCC 50608 |
| Encephalitozoon intestinalis | ATCC 50651 |
| Encephalitozoon hellum | ATCC 50504 |
| Encephalitozoon cuniculi | ATCC 50602 |
| Pentatrichomonas hominis | ATCC 30098 |
| Entamoeba barretti | ATCC 30996 |
| Entamoeba dispar | ATCC PRA-260 |
| Entamoeba gigivalis | ATCC 30927 |
| Entamoeba invadens | ATCC 30994 |
| Entamoeba moshkovskii | ATCC 30041 |
| Entamobea ranarum | ATCC 50389 |
| Cryptosporidium meleagridis | 1867 |
20
Interfering Substances
Twenty-two (22) biological and chemical substances occasionally used or found in stool specimens were evaluated for potential interference with the BD MAX Enteric Parasite Panel near the LOD for each particular target. Included in this study was an Antibiotics Mixture, which consisted of a combination of 8 different antibiotics tested simultaneously, with each antibiotic at a concentration that may be excreted in a stool specimen. Three of the substances tested exhibited potential interference with the BD MAX Enteric Parasite Panel (refer to Table 18). Vagisil cream demonstrated potential interference at concentrations greater than 9% in stool. Whole human blood demonstrated potential interference at concentrations greater than 25% in stool. Additional testing with grossly bloody clinical stool specimens showed potential interference in 1 out of a total of 12 specimens tested. Substances that demonstrated interference may result in potential unresolved, indeterminate or false negative results.
| Brand Name or Description | Result | Brand Name or Description | Result |
|---|---|---|---|
| Fecal Fat | NI | Spermicidal Lubricant | NI |
| Human DNA | NI | Diaper Rash Cream | NI |
| Mucus | NI | Vagisil (>9%) | I |
| Whole Human Blood (>25%) | I | Laxatives | NI |
| Hydrocortisone Cream | NI | Anti-Diarrheal (liquid) | NI |
| Antiseptic Towelettes | NI | Anti-Diarrheal (pill) | NI |
| Enema | NI | Antibiotics Mixture | NI |
| Hemorrhoidal Gel | NI | Antacids | NI |
| Nystatin Cream | NI | Non-Steroidal Anti-Inflammatory (NSAID) | NI |
| 10% Buffered Formalin | NI | Topical Antibiotic | NI |
| 20% Buffered Formalin | NI | Grossly Bloody Stool | I |
Table 18: Endogenous and Commercial Exogenous Substances Tested with the BD MAX Enteric Parasite Panel
I: Interference with the BD MAX Enteric Parasite Panel.
NI: No reportable interference with the BD MAX Enteric Parasite Panel.
21
Carryover/Cross-Contamination
A study was conducted to investigate within-run carryover and between-run carryover while processing specimens with a high load of Giardia lamblia. Cryptosporidium parvum and Entamoeba histolytica in the BD MAX Enteric Parasite Panel made of one high positive member containing the three target organisms and one negative member was used to prepare numerous samples. Isolates of Giardia lamblia, Entamoeba histolytica and Cryptosporidium parvum were used for the high positive panel member (1 x 10 cysts/trophozoites per mL). The negative member did not contain any target analyte. Twelve (12) replicates of the high positive panel member and 12 replicates of the negative panel member were tested in each run by alternating negative and positive samples. Two (2) operators performed a total of 15 runs with each run containing 24 samples.
Carryover contamination was assessed for each target in the BD MAX Enteric Parasite Panel. A total of 180 Sample Buffer Tubes, each containing the 3 BD MAX Enteric Parasite Panel targets, were assessed in the carvover contamination study. All of the 180 spiked Sample Buffer Tubes produced the expected positive results for all 3 target organisms. A total of 180 Sample Buffer Tubes, each negative for all 3 BD MAX Enteric Parasite Panel targets, were also assessed in the carryover contamination study. One hundred and seventy-eight (178) of the 180 spiked Sample Buffer Tubes produced the expected negative results for all 3 target organisms. One expected negative for Giardia lamblia and the second was positive for both Giardia lamblia and Entamoeba histolytica in a single Sample Buffer Tube.
Mixed Infection/Competitive Interference
The mixed infection/competitive interference study was designed to evaluate the ability of the BD MAX Enteric Panel to detect low positive results in the presence of other targets at high concentrations. Four (4) organisms (Giardia lamblia, Cryptosporidium parvum and two preparations of Entamoeba histolytica) were individually prepared at 2X their respective LOD to serve as a low target in the BD MAX Enteric Parasite Panel Sample Buffer Tube. A high target mix comprised of the organisms representative of the other two BD MAX Enteric Parasite Panel analytes at a concentration of > 1x10 organisms/mL in the Sample Buffer Tube was spiked into the Sample Buffer Tube along with 10 µL of unpreserved stool and tested to simulate mixed infections. The second target mix for Entamoeba histolytica also contained Entamoeba dispar prepared in the same manner as just described. All four low target organisms were successfully detected by the BD MAX Enteric Parasite Panel when combined with their respective simulated high target concentration mixed infection preparations.
Clinical Performance Studies
A clinical study was designed to assess the performance of the BD MAX Enteric Parasite Panel for the identification of Giardia lamblia, Cryptosporidium parvum/hominis and Entamoeba histolytica, from unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, enteritis and/or colitis. This multicenter study evaluated results obtained with the BD MAX Enteric Parasite Panel compared to those obtained with the reference method. Clinical centers were employed to collect and test patient specimens; whereas collection centers were employed to collect patient specimens, with the reference method and EPP testing being performed off-site.
The study involved a total of five (5) clinical sites where specimens were collected as part of routine patient care, enrolled into the trial, and tested on the BD MAX Enteric Parasite Panel as well as seven (7) collection sites. Only excess, de-identified patient specimens were used. Additionally, an internal site was involved as a clinical center to perform BD MAX Enteric Parasite Panel testing on specimens supplied by
22
collection centers. Samples tested at BD were obtained from all collection sites. Specimens collected at the sites consisted of a mix of 10% formalin-fixed and unpreserved specimens as well as a mix of prospective and retrospective specimens.
Clinical centers were selected for the clinical study based on a number of criteria, such as investigator and site personnel availability, number of specimens of interest tested for each target, prevalence, and familiarity with PCR methodology. The clinical centers were also selected according to the specimen types that they routinely collect.
A total of 2204 prospective specimens (1128 10% formalin-fixed, 1058 unpreserved and 18 noncompliant) and 411 retrospective specimens (148 10% formalin-fixed, 251 unpreserved and 12 noncompliant) were enrolled in the clinical evaluation. Table 19 describes the number of compliant specimens enrolled by patient age and specimen type. A total of 128 retrospective specimens were not included in the performance calculations below as the historical results were not confirmed by an alternate PCR and bi-directional sequencing.
| Age Group | Specimen Type
Formalin 10% | Specimen Type
Unpreserved | Specimen Type
Combined |
|--------------------|-------------------------------|------------------------------|---------------------------|
| 0-1 month | 1 | 0 | 1 |
| 1 month to 2 years | 111 | 51 | 162 |
| 2-12 years | 218 | 76 | 294 |
| 13-18 years | 121 | 77 | 198 |
| 19-21 years | 37 | 34 | 71 |
| Over 21 years | 723 | 782 | 1505 |
| Unknown | 62 | 202 | 264 |
| Total | 1273 | 1222 | 2495 |
Table 19: Compliant clinical trial enrollment summary by age group and specimen type
For the 10% formalin fixed specimen type, the BD MAX Enteric Parasite Panel identified 95.5% and 99.7% of the Giardia lamblia prospective and negative specimens, respectively, and 100% and 100% of the retrospective positive and negative specimens, respectively. For the unpreserved specimen type, the BD MAX Enteric Parasite Panel identified 94.4% and 100% of the Giardia lamblia prospective positive and negative specimens, respectively, and 98.6% and 94.9% of the retrospective and negative specimens, respectively (Table 20).
23
| Specimen
Type | Specimen
Origin | BD MAX
Enteric
Parasite
Panel | RM | | Total | |
|-----------------------|--------------------------------------------------------------------------------------------|----------------------------------------|----|------|-------|--|
| | | | P | N | | |
| 10% Formalin
Fixed | Prospective | P | 21 | 32 | 24 | |
| | | N | 11 | 996 | 997 | |
| | | Total | 22 | 999 | 1021 | |
| | SENSITIVITY (95% CI): 95.5% (78.2%, 99.2%)
SPECIFICITY (95% CI): 99.7% (99.1%, 99.9%) | | | | | |
| | Retrospective | P | 55 | 0 | 55 | |
| | | N | 0 | 71 | 71 | |
| | | Total | 55 | 71 | 126 | |
| | PPA (95% CI): 100.0% (93.5%, 100.0%)
NPA (95% CI): 100.0% (94.9%, 100.0%) | | | | | |
| Unpreserved | Prospective | P | 17 | 0 | 17 | |
| | | N | 13 | 655 | 656 | |
| | | Total | 18 | 655 | 673 | |
| | SENSITIVITY (95% CI): 94.4% (74.2%, 99.0%)
SPECIFICITY (95% CI): 100.0% (99.4%, 100.0%) | | | | | |
| | Retrospective | P | 72 | 75,6 | 79 | |
| | | N | 14 | 129 | 130 | |
| | | Total | 73 | 136 | 209 | |
| | PPA (95% CI): 98.6% (92.6%, 99.8%)
NPA (95% CI): 94.9% (89.8%, 97.5%) | | | | | |
Table 20: Giardia lamblia – Clinical Performance
- l The alternate PCR and bi-directional sequencing component of the reference method was negative for this specimen. The DFA component of the reference method was positive. Discrepant repeat testing with an alternate PCR and bi-directional sequencing was performed and gave a negative result. Discrepant repeat testing with DFA was done a negative result. Discrepant repeat testing with the BD MAX™ Enteric Panel was performed in twelve (12) replicates and gave all negative results (012). The specimen was also tested using a Giardia antigen EIA as discrepant testing and gave a negative result.
- 2 One (1) specimen was tested using a Giardia antisen detecting EIA as discrepant testing and gave a negative result. Discrepant repeat testing with the BD MAX™ Enteric Panel was performed in six (6) replicates of this specimen and gave 1/6 positive result. No discrepant testing was performed for the other two (2) specimens.
- 3 The alternate PCR and bi-directional sequencing component of the reference method was negative for this specimen. The DFA segment of the reference method was positive. Discrepant repeat testing with the alternate PCR and bi-directional sequencing was performed and gave a negative result. Discrepant repeat testing with DFA was performed and gave a positive result. Discrepant repeat testing with the BD MAX™ Enteric Parasite Panel was performed in six (6) replicates and gave all negative results (0/6). This specimen was also tested using an antigen detecting EIA as discrepant testing and gave a negative result.
- 4 No discrepant testing was performed for this specimen.
- 5 One (1) specimen was tested using an antigen detecting EIA and a commercially-available molecular assay as discrepant testing and gave a positive result for both. Discrepant repeat testing with the BD MAX™ Enteric Parasite Parasite in six (6) replicates of this specimen and gave all positive results (6/6).
- 6 One (1) specimen was tested using an EIA and a commercially-available molecular assay as discrepant testing. The EIA gave a positive result and the molecular assay gave a negative result. Discrepant repeat testing with the BD MAX™ Enteric Panel was done in eleven (11) replicates of this specimen and gave 5 positive results (5/11). No discrepant testing was performed for the other five (5) specimens.
24
For the 10% formalin fixed specimen type, the BD MAX Enteric Parasite Panel identified 90.3% of the Cryptosporidium parvum/hominis prospective positive and negative specimens, respectively, and 93% and 100% of the retrospective positive and negative specimens, respectively. For the unpreserved specimen type, the BD MAX Enteric Parasite Panel identified 100% and 99.5% of the Cryptosporidium parvum/hominis prospective positive and negative specimens, respectively, and 97.7% and 98.4% of the retrospective positive and negative specimens, respectively (Table 21). Because DFA identifies Cryptosporidium to the genus level, DFA-positive specimens identified by bi-directional sequencing as other than C. hominis or C. parvum were considered reference method negative.
25
| Specimen
Type | Specimen
Origin | BD MAXTM
Enteric
Parasite Panel | RM | | Total | |
|------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------|-------|------|-------|--|
| | | | P | N | | |
| 10% Formalin
Fixed | Prospective | P | 56 | 23 | 58 | |
| | | N | 61, 2 | 9514 | 957 | |
| | | Total | 62 | 953 | 1015 | |
| SENSITIVITY: 90.3% (80.5%, 95.5%)
SPECIFICITY: 99.8% (99.2%, 99.9%) | | | | | | |
| | Retrospective | P | 40 | 0 | 40 | |
| | | N | 35 | 78 | 81 | |
| | | Total | 43 | 78 | 121 | |
| PPA: 93% (81.4%, 97.6%)
NPA: 100% (95.3%, 100%) | | | | | | |
| Unpreserved | Prospective | P | 35 | 36 | 38 | |
| | | N | 0 | 625 | 625 | |
| | | Total | 35 | 628 | 663 | |
| | | SENSITIVITY: 100% (90.1%, 100%)
SPECIFICITY: 99.5% (98.6%, 99.8%) | | | | |
| | Retrospective | P | 43 | 37 | 46 | |
| | | N | 1 | 181 | 182 | |
| | | Total | 44 | 184 | 228 | |
| | PPA: 97.7% (88.2%, 99.6%)
NPA: 98.4% (95.3%, 99.4%) | | | | | |
Table 21: Cryptosporidium parvum/hominis - Clinical Performance
- All six (6) specimens were positive by the DFA composite reference method. One (1) specimen sequenced as C. 1 parvum, three (3) specimens were negative and two (2) were non-reportable by the alternate PCR and bi-directional sequencing components of the composite reference method.
- 2 Discrepant repeat testing with the alternate PCR and bi-directional sequencing was performed on all six (6) specimens. One (1) specimen sequenced as Cryptosporidium parvum, one (1) specimen sequenced as Cryptosporidium felis and the remaining four (4) were PCR negative by discrepant repeat testing was also performed using an antigen detecting EIA that does not distinguish between Cryptosporidium and Giardia. Two specimens were EIA negative and four specimens were EIA positive, of which two were positive for Giardia by other test methods.
- 3 One DFA-positive specimen was classified as reference method negative based on alternate PCR and bi-directional sequencing results that identified Cryptosporidium meleagridis.
- 4 Six DFA-positive specimens were classified as reference method negative based on alternate PCR and bi-directional sequencing results that identified (4) Cryptosporidium canis, (1) C. meleagridis and (1) Cryptosporidium spp. (undefined).
- ર Discrepant repeat testing was performed with BD MAX Enteric Parasite Panel in twelve (12) replicates per specimen. One specimen was positive for five (5) of twelve (12) replicates and one specimen was positive for two (2) of twelve (12) replicates.
- Discrepant repeat testing was performed with BD MAX Enteric Panel in six (6) replicates per specimen. One specimen was 6 positive for five (5) of six (6) replicates and one specimen was positive for three (3) of six (6) replicates. A third specimen was negative in six (6) of six (6) replicates.
- 7 Discrepant repeat testing was performed with BD MAX Enteric Panel in six (6) replicates per specimen. Two specimens were negative for six (6) of six (6) replicates.
26
For the 10% formalin fixed specimen type, the BD MAX Enteric Parasite Panel identified 100% of the Entamoeba histolytica negative specimens for both the prospective and retrospective specimens. There were no prospective or retrospective 10% formalin fixed Entamoeba histolytica positive specimens found during the clinical evaluation. For the unpreserved specimen type, the BD MAX Enteric Parasite Panel identified 100% Entamoeba histolytica prospective negative specimens and 100% of the retrospective positive and negative specimens, respectively (Table 22). There were no prospective unpreserved Entamoeba histolytica positive specimens found during the clinical evaluation.
| Specimen Type | Specimen Origin | BD MAX
Enteric
Parasite Panel | RM | | Total |
|-----------------------|-------------------------------------------------------------------------------------------|-------------------------------------|----|-----|-------|
| | | | P | N | |
| 10% Formalin
Fixed | Prospective | P | 0 | 0 | 0 |
| | | N | 0 | 827 | 827 |
| | | Total | 0 | 827 | 827 |
| | SENSITIVITY (95% CI): No data for calculation
SPECIFICITY (95% CI): 100% (99.5%, 100%) | | | | |
| | Retrospective | P | 0 | 0 | 0 |
| | | N | 0 | 54 | 54 |
| | | Total | 0 | 54 | 54 |
| | PPA (95% CI): No data for calculation
NPA (95% CI): 100% (93.4%, 100%) | | | | |
| Unpreserved | Prospective | P | 0 | 0 | 0 |
| | | N | 0 | 577 | 577 |
| | | Total | 0 | 577 | 577 |
| | SENSITIVITY (95% CI): No data for calculation
SPECIFICITY (95% CI): 100% (99.3%, 100%) | | | | |
| | Retrospective | P | 11 | 0 | 11 |
| | | N | 0 | 191 | 191 |
| | | Total | 11 | 191 | 202 |
| | PPA (95% CI): 100% (74.1%, 100%)
NPA (95% CI): 100% (98.0%, 100%) | | | | |
Table 22: Entamoeba histolytica - Clinical Performance
As Entamoeba histolytica is a rare analyte, both prospective testing efforts were unable to demonstrate the positive percent agreement of the BD MAX Enteric Parasite Panel. To supplement the prospective and retrospective data, an evaluation of contrived specimens was performed. Surrogate clinical specimens were prepared using residual specimens that had previously tested negative for all BD MAX Enteric Parasite Panel targets. Specimens were spiked at clinically relevant levels at various concentrations of the limit of detection for each specimen type. Users analyzing the specimens were blinded as to the specimen status.
27
For both the 10% formalin fixed and unpreserved specimen types, the BD MAX Enteric Parasite Panel correctly identified 100% of both the positive and negative specimens. The contrived study results obtained with the BD MAX Enteric Parasite Panel were compared to the expected results and are summarized in Table 23.
| Specimen Type | BD MAX
Enteric Parasite Panel | Expected Result | | Total |
|----------------------------------------------------------------------|----------------------------------|-----------------|----|-------|
| | | P | N | |
| Formalin 10% | P | 50 | 0 | 50 |
| | N | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
| PPA (95% CI): 100% (92.9%, 100%)
NPA (95% CI): 100% (92.9%, 100%) | | | | |
| Unpreserved | P | 50 | 0 | 50 |
| | N | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
| PPA (95% CI): 100% (92.9%, 100%)
NPA (95% CI): 100% (92.9%, 100%) | | | | |
| Table 23: Entamoeba histolytica - Contrived Specimen Performance | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | ------------------------------------------------------------------ |
Performance of the BD MAX Enteric Parasite Panel by Cryptosporidium hominis and Cryptosporidium parvum species identification as observed during the clinical trial is presented below in Table 24. The species identification was obtained from the alternate PCR and bi-directional sequencing segment of the composite reference method. While the BD MAX Enteric Parasite Panel is designed to detect the species described below, the panel does not report results to the species level.
Table 24: Cryptosporidium PPA per species observed during the clinical trial
| Cryptosporidium | PPA | ||||
|---|---|---|---|---|---|
| Specimen Type | Specimen Origin Species | Estimate | 95% CI | ||
| 10% Formalin Fixed | Prospective | hominis | 100.0% (17/17) | (81.6%, 100.0%) | |
| parvum | 97.4% (37/38) | (86.5%, 99.5%) | |||
| Retrospective | hominis | 95.0% (19/20) | (76.4%. 99.1%) | ||
| parvum | 91.3% (21/23) | (73.2%. 97.6%) | |||
| Unpreserved | hominis | 100.0% (22/22) | (85.1%, 100.0%) | ||
| Prospective | parvum | 100.0% (11/11) | (74.1%, 100.0%) | ||
| Retrospective | hominis | 96.2% (25/26) | (81.1%, 99.3%) | ||
| parvum | 100.0% (18/18) | (82.4%. 100.0%) |
28
There were twenty-three (23) co-infections detected by the BD MAX Enteric Parasite Panel. Table 25 below shows the co-infections detected by the BD MAX Enteric Parasite Panel during the clinical trial.
| Co-Infections | | Number of Co-
Infections
Observed | Number of
Discrepant
Co-Infections | Discrepant Target | Unavailable
Reference Method
Result for Comparison |
|-----------------------------------|-----------------------------------|-----------------------------------------|------------------------------------------|-----------------------------------|--------------------------------------------------------------|
| Cryptosporidium
parvum/hominis | Entamoeba
histolytica | 3 | 1 | Cryptosporidium
hominis/parvum | 1 Cryptosporidium
parvum/hominis |
| Giardia lamblia | Cryptosporidium
parvum/hominis | 11 | 2 | Cryptosporidium
parvum/hominis | 3 Giardia lamblia and
4 Cryptosporidium
parvum/hominis |
| Giardia lamblia | Entamoeba
histolytica | 9 | 41 | Giardia lamblia | 1 Giardia lamblia and
3 Entamoeba histolytica |
Table 25: Co-infections observed during the BD MAX Enteric Parasite Panel clinical trial
1 All four (4) are retrospective specimens with unconfirmed historical results.
Of the 2226 specimens initially evaluated with the BD MAX Enteric Parasite Panel, 1.5% of the 10% formalin fixed and 4.7% of the unpreserved specimens were initially reported as Unresolved. Following a valid repeat test, 0% of the 10% formalin fixed and 1.2% of the unpreserved specimens remained Unresolved. The total numbers provided in Table 26 are based on compliant specimens and BD MAX Enteric Parasite Panel results.
Table 26: Unresolved Rates
| | | Initial Unresolved Rate with
95% CI | | Final Unresolved Rate with Valid Repeat
with 95% CI | |
|------------------|--------------------|----------------------------------------|--------------|--------------------------------------------------------|--------------|
| Specimen
Type | Specimen
Origin | Percent | 95% CI | Percent | 95% CI |
| Formalin 10% | Prospective | 1.5% (16/1084) | (0.9%, 2.4%) | 0.0% (0/1084) | (0.0%, 0.4%) |
| Formalin 10% | Retrospective | 1.4% (2/146) | (0.4%, 4.9%) | 0.0% (0/146) | (0.0%, 2.6%) |
| Unpreserved | Prospective | 5.6% (42/752) | (4.2%, 7.5%) | 1.5% (11/747) | (0.8%, 2.6%) |
| Unpreserved | Retrospective | 2.0% (5/244) | (0.9%, 4.7%) | 0.4% (1/244) | (0.1%, 2.3%) |
Of the 2226 specimens initially evaluated with the BD MAX Enteric Parasite Panel, 0.3% of the 10% formalin fixed and 0.1% of the unpreserved specimens were initially reported as Indeterminate. Following a valid repeat test, 0% of both the 10% formalin fixed and the unpreserved specimens remained Indeterminate. The total numbers provided in Table 27 are based on compliant specimens and BD MAX Enteric Parasite Panel results.
29
| | | Initial Indeterminate Rate with
95% CI | | Final Indeterminate Rate with Valid
Repeat with 95% CI | |
|------------------|--------------------|-------------------------------------------|--------------|-----------------------------------------------------------|--------------|
| Specimen
Type | Specimen
Origin | Percent | 95% CI | Percent | 95% CI |
| Formalin 10% | Prospective | 0.4% (4/1084) | (0.1%, 0.9%) | 0.0% (0/1084) | (0.0%, 0.4%) |
| | Retrospective | 0.0% (0/146) | (0.0%, 2.6%) | 0.0% (0/146) | (0.0%, 2.6%) |
| Unpreserved | Prospective | 0.1% (1/752) | (0.0%, 0.7%) | 0.0% (0/747) | (0.0%, 0.5%) |
| | Retrospective | 0.0% (0/244) | (0.0%, 1.5%) | 0.0% (0/244) | (0.0%, 1.5%) |
Table 27: Indeterminate Rates
Of the 2226 specimens initially evaluated with the BD MAX Enteric Parasite Panel, 0.6% of the 10% formalin fixed and 0.4% of the unpreserved specimens were initially reported as Incomplete. Following a valid repeat test, 0% of both the 10% formalin fixed and the unpreserved specimens remained Incomplete. The total numbers provided in Table 28 are based on compliant specimens and BD MAX Enteric Parasite Panel results.
Table 28: Incomplete Rates
| | | Initial Incomplete Rate with
95% CI | | Final Incomplete Rate with
Valid Repeat with 95% CI | |
|------------------|--------------------|----------------------------------------|--------------|--------------------------------------------------------|--------------|
| Specimen
Type | Specimen
Origin | Percent | 95% CI | Percent | 95% CI |
| Formalin
10% | Prospective | 0.6% (6/1084) | (0.3%, 1.2%) | 0.0% (0/1084) | (0.0%, 0.4%) |
| | Retrospective | 0.7% (1/146) | (0.1%, 3.8%) | 0.0% (0/146) | (0.0%, 2.6%) |
| Unpreserved | Prospective | 0.0% (0/752) | (0.0%, 0.5%) | 0.0% (0/747) | (0.0%, 0.5%) |
| | Retrospective | 1.6% (4/244) | (0.6%, 4.1%) | 0.0% (0/244) | (0.0%, 1.5%) |