(92 days)
Not Found
No
The description focuses on the chemical composition and physical format of the controls, and the detection mechanism is based on specific melting temperature (Tm) values, which is a standard molecular biology technique, not AI/ML. There is no mention of algorithms learning from data or making predictions.
No
This device is an external control kit used to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures, not to directly treat or diagnose a condition in a patient.
No
This device is an external control kit used to monitor the performance of an in vitro diagnostic device (the FilmArray® Global Fever Panel), not to directly diagnose a patient's condition.
No
The device is a physical kit containing vials with dried synthetic DNA segments and buffer, intended for use as quality controls in a laboratory setting. It is not solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit contains "Positive External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures".
- Device Description: The description further clarifies that these controls are used with the FilmArray Global Fever Panel, which is itself an in vitro diagnostic device for detecting pathogens. The controls are designed to "monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures".
- Care Setting: The intended user is an "in vitro diagnostic laboratory".
The device is a control kit used with an IVD device (the FilmArray Global Fever Panel) to ensure the proper functioning of the diagnostic test. Therefore, it is considered an IVD itself as it is an accessory used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The FilmArray® Global Fever Panel External Control Kit contains Positive External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.
Both the Positive and Negative External Controls are provided in a FilmArray Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the FilmArray Global Fever Panel. The Negative Control Injection Vial contains no DNA, and is non-reactive with the Global Fever Panel assays.
Product codes (comma separated list FDA assigned to the subject device)
PMN
Device Description
The FilmArray Global Fever Panel External Control Kit contains Positive and Negative External Controls. The Positive External Control has been optimized to be detected by all pathogen assays contained in the Global Fever Panel (Table 1). The Negative External Control contains no nucleic acid and a successful run will be negative for all assays on the panel. These controls are not intended to replace the internal FilmArray Global Fever Panel pouch controls (RNA process control and second stage PCR array control). The Global Fever Panel External Control Kit contains no biological hazards and is 100% non-infectious.
The External Controls are referenced in the Ouick Guide and product literature as Control Injection Vials. The use of room-temperature stable External Controls contained within an injection vial simplifies the workflow and allows for use of the External Controls in settings where access to refrigeration may be limited. Each individually packaged, ready-to-use FilmArray Global Fever External Control is processed separately according to the Instructions for Use, and follows the procedure as outlined in the Quick Guide for the FilmArray Global Fever External Control Kit. Each External Control Injection Vial is intended for a single use.
The Global Fever Panel External Control Kit is designed to mitigate the risk of control contamination and misuse when evaluating clinical samples on the FilmArray 2.0 System.
- Negative External Controls are tested using the Negative External Control protocol, which monitors for contamination from both external control material and target pathogens; it will fail if either is detected.
- The Positive External Contains DNA sequences that produce signature amplicon melting temperature (Tm) values distinct from the amplicon Tm values produced by each of the pathogens detected by the Global Fever Panel. By design, the Positive ECM will not be detected when using the Global Fever Panel Whole Blood Protocol, and reciprocally, amplified pathogen-specific nucleic acid will not be detected when using the Positive External Control Protocol. Through modification of the sequence between the inner primers for each ECM target, the Tm value of the amplicon is shifted to higher or lower Tm values relative to the expected Global Fever Panel target amplicon while running the same Global Fever Panel pouches with the same physical pouch manipulation in the FilmArray 2.0 Instrument. Positive External Control-specific pouch module software detects the expected shifted Tm values as being from ECM amplicon, thereby evaluating the performance of the FilmArray 2.0 System. Also, the modification of the ECM sequence mitigates possible contamination events and does not cause false positives in clinical samples. In the unlikely event that Positive ECM or ECM amplicon is introduced into a patient sample, the resulting amplification Tm value(s) is not detected within the pathogen(s) Tm window in the Global Fever Panel Whole Blood Protocol. where different Tm windows are used to detect amplified pathogen sequence.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: During the prospective clinical evaluation of the FilmArray Global Fever Panel, six sites were required to perform one valid Global Fever Panel External Control test at the start of each day of specimen testing or contamination monitoring. A valid External Control run was one that exactly matched the expected results for each analyte in the mix (i.e., Positive or Negative).
Sample size: 317 External Control tests (160 positive and 157 negative).
Key results: Overall External Control 'Passed' rate of 98.7% (313/317).
Positive External Controls: 159/160 (99.4%) completed with expected result.
Negative External Controls: 155/157 (98.7%) completed with expected result.
Two Positive External Controls (2/160; 1.3%) and two Negative External Controls (2/157; 1.3%) had unexpected (Failed) results.
Negative External Control testing identified one instance of pathogen contamination out of 157 tests, but no instances of External Control amplicon contamination. In all cases of a 'Failed' External Control test, the site immediately tested a new External Control and obtained the expected result.
Repeatability / Multi-Site Reproducibility:
Repeatability: One operator testing one kit lot of External Controls using one reagent kit lot on one FilmArray 2.0 Instrument over 14 days.
Sample size: 45 Positive and 45 Negative External Controls.
Key results: All 45 Positive and 45 Negative External Controls passed with no failures (100% agreement).
For Positive External Controls, all target assays had Tm standard deviations between 0.1-0.2℃, with coefficient of variation (CV) between 0.1-0.3%.
Multi-site Reproducibility: Evaluated in a multi-site study using three External Control kits and three reagent pouch lots. Testing was performed at three sites, with two operators and three FilmArray 2.0 instruments at each site.
Sample size: 135 Positive and 135 Negative External Controls (45 per site).
Key results:
Overall Agreement with Expected Result: 265/270 (98.1%) [95.7-99.2%].
Positive External Controls: 132/135 (97.8%) [93.7-99.2%] passed. Three Positive External Controls failed.
Negative External Controls: 133/135 (98.5%) [94.8-99.6%] passed. Two Negative External Control failures were caused by detection of pathogen and not due to contamination with Positive External Control material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Testing:
Positive External Controls: 99.4% completed with expected result.
Negative External Controls: 98.7% completed with expected result.
Overall External Control 'Passed' rate: 98.7%.
Repeatability / Multi-Site Reproducibility:
Repeatability:
Positive: Observed/Expected (Percent Agreement) 45/45 (100%)
Negative: Observed/Expected (Percent Agreement) 45/45 (100%)
Multi-Site Reproducibility:
Positive: All Sites Observed/Expected (Percent Agreement) [95% Confidence Interval] 132/135 (97.8%) [93.7-99.2%]
Negative: All Sites Observed/Expected (Percent Agreement) [95% Confidence Interval] 133/135 (98.5%) [94.8-99.6%]
Overall Agreement with Expected Result: 265/270 (98.1%) [95.7-99.2%]
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FilmArray Warrior Control Panel M290 (K163522)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3920 Assayed quality control material for clinical microbiology assays.
(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2020
BioFire Defense. LLC Cynthia Phillips VP of Regulatory, Quality, and Clinical Affairs 79 West 4500 South, Suite 14 Salt Lake City, Utah 84107
Re: K202382
Trade/Device Name: FilmArray Global Fever Panel External Control Kit Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: August 19, 2020 Received: August 20, 2020
Dear Cynthia Phillips:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kristian Roth, Ph.D. Branch Chief Bacterial Respiratory and Medical Counter Measures Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202382
Device Name
FilmArray Global Fever Panel External Control Kit
Indications for Use (Describe)
The FilmArray® Global Fever Panel External Control Kit contains Positive External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.
Both the Positive and Negative External Controls are provided in a FilmArray Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the FilmArray Global Fever Panel. The Negative Control Injection Vial contains no DNA, and is nonreactive with the Global Fever Panel assays.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
510(k) Number:
Purpose for submission: New product Applicant Information:
| Applicant: | BioFire Defense, LLC |
|---|---|
| Address: | 79 West 4500 South, Suite 14 |
| Salt Lake City, Utah 84107 | |
| Contact Person: | Cynthia Phillips, VP of Regulatory, Quality, and Clinical Affairs |
| Phone: | 801-262-3592 extension 1370 |
| Fax: | 801-447-6907 |
| Email Address: | cynthia.phillips@biofiredefense.com |
Preparation Date: August 19, 2020
De vice
| Device Trade Name: | FilmArray® Global Fever Panel External Control Kit |
|---|---|
| Device Common Name: | Quality Control Material for Microbiology Assays |
| Device Type: | Assayed quality control material for clinical microbiology |
| assays | |
| Class: | Class II (Special Controls) |
| Regulation: | 21 CFR 866.3920 |
| Panel: | Microbiology - 83 |
| Product code: | PMN |
Predicate Device
FilmArray Warrior Control Panel M290 (K163522)
De vice De scription
The FilmArray Global Fever Panel External Control Kit contains Positive and Negative External Controls. The Positive External Control has been optimized to be detected by all pathogen assays contained in the Global Fever Panel (Table 1). The Negative External Control contains no nucleic acid and a successful run will be negative for all assays on the panel. These controls are not intended to replace the internal FilmArray Global Fever Panel pouch controls (RNA process control and second stage PCR array control). The Global Fever Panel External Control Kit contains no biological hazards and is 100% non-infectious.
4
| Disease | Pathogen Assay Result | Type |
|---|---|---|
| Leptospirosis | Leptospira spp. | Bacterial |
| Malaria | Plasmodium spp. | |
| Plasmodium falciparum | ||
| Plasmodium vivax/ovale | Protozoan | |
| Chikungunya fever | Chikungunya virus | Viral |
| Dengue fever | Dengue virus | Viral |
Table 1. Pathogens Detected by the FilmArray Global Fever Panel
The External Controls are referenced in the Ouick Guide and product literature as Control Injection Vials. The use of room-temperature stable External Controls contained within an injection vial simplifies the workflow and allows for use of the External Controls in settings where access to refrigeration may be limited. Each individually packaged, ready-to-use FilmArray Global Fever External Control is processed separately according to the Instructions for Use, and follows the procedure as outlined in the Quick Guide for the FilmArray Global Fever External Control Kit. Each External Control Injection Vial is intended for a single use.
The Global Fever Panel External Control Kit is designed to mitigate the risk of control contamination and misuse when evaluating clinical samples on the FilmArray 2.0 System.
- Negative External Controls are tested using the Negative External Control protocol, ● which monitors for contamination from both external control material and target pathogens; it will fail if either is detected.
- The Positive External Contains DNA sequences that produce signature amplicon melting temperature (Tm) values distinct from the amplicon Tm values produced by each of the pathogens detected by the Global Fever Panel. By design, the Positive ECM will not be detected when using the Global Fever Panel Whole Blood Protocol, and reciprocally, amplified pathogen-specific nucleic acid will not be detected when using the Positive External Control Protocol. Through modification of the sequence between the inner primers for each ECM target, the Tm value of the amplicon is shifted to higher or
5
lower Tm values relative to the expected Global Fever Panel target amplicon while running the same Global Fever Panel pouches with the same physical pouch manipulation in the FilmArray 2.0 Instrument. Positive External Control-specific pouch module software detects the expected shifted Tm values as being from ECM amplicon, thereby evaluating the performance of the FilmArray 2.0 System. Also, the modification of the ECM sequence mitigates possible contamination events and does not cause false positives in clinical samples. In the unlikely event that Positive ECM or ECM amplicon is introduced into a patient sample, the resulting amplification Tm value(s) is not detected within the pathogen(s) Tm window in the Global Fever Panel Whole Blood Protocol. where different Tm windows are used to detect amplified pathogen sequence.
De vice Intended Use
The FilmArray® Global Fever Panel External Control Kit contains Positive and Negative External Controls intended for use as assaved quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.
Both the Positive and Negative External Controls are provided in a FilmArray Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the FilmArray Global Fever Panel. The Negative Control Injection Vial contains no DNA, and is non-reactive with the Global Fever Panel assays.
| Element | New Device:
FilmArray Global Fever Panel
External Control Kit | Predicate:
FilmArray Warrior Control Panel
M290 (K163522) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | Positive and Negative External
assayed quality controls to monitor
multiple targets in an in vitro lab
nucleic acid diagnostic test | Same |
| Technological Principles | Nested multiplex RT-PCR followed by
melting analysis to confirm identity of
amplified product. | Same |
| Test Interpretation | Automated test interpretation and
report generation. User cannot access
raw data. | Same |
| Sample Preparation Method | Process like patient sample. | Same |
| Composition | Tm-shifted Synthetic DNA | Synthetic DNA |
| Physical format | External Control Material dried on
Control Injection Vialfilter | Ready-to-use liquid |
Substantial Equivalence
6
| New Device: | Predicate: | |
|---|---|---|
| Element | FilmArray Global Fever Panel | |
| External Control Kit | FilmArray Warrior Control Panel | |
| M290 (K163522) | ||
| Reagent Storage | Reagents are stored at room | |
| temperature (18° to 30°C). | Reagents are stored refrigerated | |
| (2°C to 8°C). | ||
| Pouch Module Software | External Control-specific protocols | |
| providing overall passed or failed | ||
| results. | Sample specific protocols | |
| providing pathogen-specific | ||
| results. |
Summary Performance Data
Clinical Testing
During the prospective clinical evaluation of the FilmArray Global Fever Panel, six sites were required to perform one valid Global Fever Panel External Control test at the start of each day of specimen testing or contamination monitoring. A valid External Control run was one that exactly matched the expected results for each analyte in the mix (i.e., Positive or Negative). Results are shown in Table 2.
Table 2. FilmArray Global Fever Panel External Control Performance as Compared to the Expected ('Passed') Result
| External Control
Type | Completed with Expected
Result | Total Completed | % |
|--------------------------|-----------------------------------|-----------------|-------|
| Positive | 159a | 160 | 99.4% |
| Negative | 155a | 157 | 98.7% |
| Overall | 314 | 317 | 99.1% |
ª Appeared that user accidentally swapped Positive External Control-loaded pouches on instrument load.
Between July 2019 and January 2020, a total of 317 External Control tests (160 positive and 157 negative) were completed and had internal pouch controls that passed. Two Positive External Controls (2/160; 1.3%) and two Negative External Controls (2/157; 1.3%) had unexpected (Failed) results, for an overall External Control 'Passed' rate of 98.7% (313/317). Negative External Control testing identified one instance of pathogen contamination out of 157 tests, but no instances of External Control amplicon contamination. In all cases of a 'Failed' External Control test, the site immediately tested a new External Control and obtained the expected result.
Repeatability / Multi-Site Reproducibility
Repeatability was evaluated by having one operator testing one kit lot of External Controls using one reagent kit lot on one FilmArray 2.0 Instrument over 14 days. Table 3 shows the results for the Repeatability evaluation.
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| Global Fever Panel
External Control Type | Expected Result | Observed/Expected
(Percent Agreement) |
|---------------------------------------------|-----------------|------------------------------------------|
| Positive | Passed 1 | 45/45
(100%) |
| Negative | Passed 2 | 45/45
(100%) |
Table 3. Summary of Global Fever Panel External Control Repeatability Test Results
1 All Global Fever Panel assays have a positive amplicon melt in the External Control melt range.
2 All Global Fever Panel assays have no melt in both the External Control melt range and in the pathogen melt range.
All 45 Positive and 45 Negative External Controls passed with no failures and therefore no additional testing was performed. For Positive External Controls, all target assays had Tm standard deviations between 0.1-0.2℃, with coefficient of variation (CV) between 0.1-0.3%. Combined with the pass rate, these results demonstrate repeatability for both the Negative and Positive External Controls.
The reproducibility of External Control test results was evaluated in a multi-site study using three External Control kits and three reagent pouch lots. Testing was performed at three sites, with two operators and three FilmArray 2.0 instruments at each site.
The percent agreement between the observed and expected test results for the Positive and Negative External Controls per test site and overall are shown in Table 4.
Table 4. Multi-Site Reproducibility Test Results of the Global Fever Panel Positive and Negative External Controls
| Global Fever
Panel External
Control Type | Expected Result | Observed/Expected
(Percent Agreement)
[95% Confidence Interval] | | | |
|------------------------------------------------|-----------------|-----------------------------------------------------------------------|--------------------|--------------------|------------------------------------|
| | | Site 1 | Site 2 | Site 3 | All Sites |
| Positive | Passed 1 | 42/45
(93.3%) | 45/45
(100%) | 45/45
(100%) | 132/135
(97.8%)
[93.7-99.2%] |
| Negative | Passed 2 | 45/45
(100%) | 44/45 3
(97.8%) | 44/45 4
(97.8%) | 133/135
(98.5%)
[94.8-99.6%] |
| Overall Agreement with Expected
Result | | | | | 265/270
(98.1%)
[95.7-99.2%] |
1 All Global Fever Panel assays have a positive amplicon melt in the External Control melt range.
2 All Global Fever Panel assays have no melt in both the External Control melt range and in the pathogen melt range.
3 Unexpected detection of pathogen amplicon for an off-panel assay, suspected laboratory contamination.
4 Unexpected detection of pathogen amplicon for DENV 2 1 assay, suspected laboratory contamination.
The expected 'Passed' results for Positive External Controls were observed in 132 out of 135 (97.8%) tests, meeting the required pass rate of ≥95%. Three Positive External Controls failed; one failed due a single assay being called negative, and the other two showed no amplification of
8
External Control Material for any of the Global Fever Panel assays. For Negative External Controls, 133 out of 135 (98.5%) tests passed. The two Negative External Control failures were caused by detection of pathogen and not due to contamination with Positive External Control material.