(87 days)
Not Found
No
The summary describes a multiplex flow immunoassay kit and its performance characteristics, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) intended for the qualitative detection of IgM antibodies to T. gondii, Rubella, and CMV to aid in the diagnosis of infection. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection." This directly indicates its role in diagnosing medical conditions.
No
The device description clearly outlines physical components including vials containing beads, antibodies, and control/calibrator serums. It also mentions required materials like sheath fluid and wash solution, indicating it is a hardware-based immunoassay system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the qualitative detection of IgM antibodies to Toxoplasma gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma...". This indicates that the device is used to examine specimens derived from the human body (serum and plasma) to provide information for the diagnosis of disease (current or recent T. gondii, Rubella and/or CMV infection).
- Device Description: The description details the components of the kit, which are reagents used to perform a test on human samples.
- Intended User / Care Setting: It is intended for use in the "clinical laboratory" and is for "prescription use only," which are typical characteristics of IVDs.
- Performance Studies: The document describes performance studies conducted to evaluate the device's accuracy and reliability for its intended diagnostic purpose, including method comparison with predicate devices.
- Key Metrics: The document provides key metrics like % Agreement (similar to sensitivity and specificity in this context) which are used to evaluate the performance of diagnostic tests.
- Predicate Device(s): The mention of predicate devices (K092587 and K923166) indicates that this device is being compared to other legally marketed IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin).
The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
The BioPlex 2200 ToRC IgM Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgM Reagent Pack.
The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.
Product codes (comma separated list FDA assigned to the subject device)
PUQ, JIX, JJX, LKQ, LFZ, LGD
Device Description
BioPlex ToRC IgM Reagent Pack includes the following components:
- One (1) 10 mL vial, containing dyed beads coated with lysates of T. gondii, Rubella and CMV ● plus an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in buffer with Glycerol and protein stabilizers (bovine and caprine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (0.8.
Reproducibility Studies:
A reproducibility panel, consisting of six (6) panel members made using serum matrix and BioPlex ToRC IgM OC controls was prepared by Bio-Rad Laboratories. The serum sample panel includes one (1) low negative, one (1) high negative, one (1) low positive near cut-off, one (1) medium positive, and one (1) high positive sample, and one (1) positive control for all three (3) analytes. Reproducibility testing was performed at three (3) US testing facilities using one (1) lot of the BioPlex 2200 ToRC IgM Pack, one (1) lot of BioPlex 2200 ToRC IgM Calibrator Set and one (1) lot of BioPlex 2200 ToRC IgM Control Set. The panels were provided to each of the testing sites. Each of the panel members and control sets were tested in replicates of four (4) on two runs per day over five (5) days at three (3) sites (4 replicates x 2 run x 5 days x 3 Sites = 120 replicates per panel member). The data were analyzed for withinrun (repeatability), between-run, between-day, between-site and total precision according to the principles described in Clinical Laboratory Standards Institute (CLSI) EP15-A3. The grand mean, standard deviation (SD) and percent coefficient of variation (% CV) were calculated. SD was evaluated for samples with AI values 0.8.
Cross Reactivity:
The study was conducted to determine if samples from various disease states interfere with test results when tested with the BioPlex 2200 ToRC IgM kit. A panel of at least ten (10) specimens that are positive for each cross reactant were evaluated for possible cross reactivity with the BioPlex 2200 ToRC IgM kit for each of the three antibody assays. The cross reactive samples were tested in commercially available predicate kits in order to confirm their negative status for the target analyte.
Interfering Substances:
An interfering substances study was conducted to evaluate the potential interference of specific endogenous and exogenous substances with the BioPlex 2200 ToRC IgM kit according to CLSI EP7-A2 guideline.
No significant interference was observed in any of the substances tested.
Assay cut-off:
A final cut-off of 1.0 AI was established for the BioPlex 2200 ToRC IgM assay based on an evaluation of 401, 454 and 511 test ordered and retrospective samples for T. gondli, Rubella and CMV IgM, respectively, of which the serological status was determined from the predicate T. gondii, Rubella and CMV IgM assays. The assay will employ an equivocal zone that brackets the cut-off, which results in samples >1.1 AI being positive and
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
0
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
BIO-RAD LABORATORIES ARLENE CARILLO REGULATORY AFFAIRS REPRESENTATIVE 5500 EAST SECOND STREET BENICIA, CA 94510
Re: K170509
Trade/Device Name: Bioplex 2200 ToRC IgM, Bioplex 2200 ToRC IgM Calibrator Set. Bioplex 2200 ToRC IgM Control Set Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella virus serological reagents Regulatory Class: II Product Code: PUQ, JIX, JJX, LKQ, LFZ, LGD Dated: February 17, 2017 Received: February 21, 2017
Dear Ms. Carillo:
This letter corrects our substantially equivalent letter of May 19, 2017.
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 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
1
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 regulations (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/Resourcesfor You/Industry/default.htm. 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
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,
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K170509
Device Name BioPlex 2200 ToRC IgM Kit BioPlex 2200 ToRC IgM Calibrator Set BioPlex 2200 ToRC IgM Control Set
Indications for Use (Describe)
BioPlex 2200 ToRC IgM Kit
The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin).
The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
BioPlex 2200 ToRC IgM Calibrator Set
The BioPlex 2200 ToRC IgM Calibrator Set is intended for the BioPlex 2200 ToRC IgM Reagent Pack.
BioPlex 2200 ToRC IgM Control Set
The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.
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)
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3
BioPlex 2200 ToRC IgM 510(k) Summary
Bio-Rad Laboratories hereby submits this 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This summary provides the information to support a determination of substantial equivalence for the BioPlex 2200 ToRC IgM kit.
510(k) Number: K170509
Summary Preparation Date: February 17, 2017
Applicant: Bio-Rad Laboratories
Contact: Arlene Carillo Regulatory Affairs Representative 5500 East Second Street Benicia, CA 94510
Purpose for Submission: New Device
Measurand: IgM antibodies to Toxoplasma gondii (T. gondii), Rubella and Cytomegalovirus (CMV)
Type of Test: Multiplexed Microparticle Immunoassay based on Luminex Technology
Proprietary and Established Names:
BioPlex 2200 ToRC IgM BioPlex 2200 ToRC IgM Calibrator Set BioPlex 2200 ToRC IgM Control Set
| Product code | Classification | Regulation section | Panel |
|---|---|---|---|
| PUQ: Multiplex | |||
| flow immunoassay, | |||
| T. gondii , Rubella, | |||
| CMV IgM | Class II | 21 CFR § 866.3510 – Rubella virus | |
| Serological Agents | Microbiology | ||
| JIT, Calibrator, | |||
| Secondary | Class II | 21 CFR §862.1150 – | |
| Calibrator | Clinical Chemistry | ||
| JJY, Multi-Analyte | |||
| Controls, All Kinds | |||
| (Assayed) | Class I | 21 CFR §862.1660 – | |
| Quality Control | |||
| Material (assayed | Clinical Chemistry |
Regulatory Information:
4
| Product code | Classification | Regulation section | Panel |
|---|---|---|---|
| and unassayed |
The following is a list of regulation sections and product codes that are applicable to the individual analytes detected by the device subject of this submission.
- 21 CFR § 866.3780 – Toxoplasma gondii Serological Agents (Microbiology Panel: Class II), Product Code LGD, Enzyme Linked Immunoabsorbent Assay, Toxoplasma gondii 2. 21 CFR § 866.3510 - Rubella virus Serological Agents (Microbiology Panel: Class II), Product Code LFX, Enzyme Linked Immunoabsorbent Assay, Rubella 3. 21 CFR § 866.3175- Cytomegalovirus Serological Agents (Microbiology Panel: Class II), Product Code LFZ, Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus and LKQ, Antibody IgM, if, Cytomegalovirus Virus
Intended Use:
-
- Intended use(s):
The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin).
- Intended use(s):
The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
The BioPlex 2200 ToRC IgM Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgM Reagent Pack.
The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.
-
- Indication(s) for use: Same as Intended Use
-
- Special conditions for use statement(s): For prescription use only
-
- Special instrument requirements: Bio-Rad BioPlex 2200 System
5
Device Description:
BioPlex ToRC IgM Reagent Pack includes the following components:
- One (1) 10 mL vial, containing dyed beads coated with lysates of T. gondii, Rubella and CMV ● plus an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in buffer with Glycerol and protein stabilizers (bovine and caprine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (0.8.
| Within Run | Between Run | Between Day | Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample Type | T. gondii IgM | |||||||||||
| Panel Members | N | Mean | ||||||||||
| (AI) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| Serum | Negative | 80 | 0.5 | 0.039 | 7.9% | 0.000 | 0.0% | 0.007 | 1.3% | 0.039 | 8.0% | |
| High Negative | 80 | 0.7 | 0.034 | 4.8% | 0.011 | 1.6% | 0.012 | 1.7% | 0.037 | 5.3% | ||
| Cut-Off | 80 | 0.9 | 0.050 | 5.5% | 0.000 | 0.0% | 0.031 | 3.4% | 0.059 | 6.5% | ||
| Cut-Off | 80 | 1.0 | 0.064 | 6.3% | 0.000 | 0.0% | 0.030 | 2.9% | 0.071 | 6.9% | ||
| Low Positive | 80 | 1.3 | 0.057 | 4.3% | 0.042 | 3.2% | 0.039 | 2.9% | 0.081 | 6.1% | ||
| Positive | 80 | 2.3 | 0.113 | 5.0% | 0.000 | 0.0% | 0.034 | 1.5% | 0.118 | 5.2% | ||
| Positive | 80 | 3.3 | 0.164 | 4.9% | 0.034 | 1.0% | 0.053 | 1.6% | 0.175 | 5.3% | ||
| Potassium | ||||||||||||
| EDTA | Negative | 80 | 0.5 | 0.019 | 3.9% | 0.000 | 0.0% | 0.002 | 0.4% | 0.019 | 3.9% | |
| High Negative | 80 | 0.7 | 0.046 | 6.2% | 0.000 | 0.0% | 0.027 | 3.7% | 0.053 | 7.2% | ||
| Cut-Off | 80 | 0.9 | 0.056 | 6.3% | 0.000 | 0.0% | 0.017 | 1.9% | 0.059 | 6.6% | ||
| Low Positive | 80 | 1.2 | 0.073 | 6.0% | 0.000 | 0.0% | 0.049 | 4.0% | 0.088 | 7.3% | ||
| Positive | 80 | 2.0 | 0.089 | 4.4% | 0.037 | 1.8% | 0.062 | 3.1% | 0.114 | 5.7% | ||
| Positive | 80 | 3.2 | 0.167 | 5.3% | 0.059 | 1.9% | 0.098 | 3.1% | 0.203 | 6.4% | ||
| Sodium Heparin | Negative | 80 | 0.4 | 0.045 | 10.3% | 0.000 | 0.0% | 0.018 | 4.1% | 0.048 | 11.1% | |
| High Negative | 80 | 0.7 | 0.032 | 4.3% | 0.030 | 4.0% | 0.025 | 3.4% | 0.050 | 6.8% | ||
| Cut-Off | 80 | 0.9 | 0.058 | 6.2% | 0.025 | 2.7% | 0.022 | 2.4% | 0.067 | 7.2% | ||
| Low Positive | 80 | 1.3 | 0.068 | 5.3% | 0.000 | 0.0% | 0.035 | 2.7% | 0.076 | 5.9% | ||
| Positive | 80 | 2.1 | 0.109 | 5.3% | 0.000 | 0.0% | 0.060 | 2.9% | 0.124 | 6.0% | ||
| Positive | 80 | 3.1 | 0.117 | 3.8% | 0.000 | 0.0% | 0.049 | 1.6% | 0.127 | 4.1% | ||
| Lithium Heparin | Negative | 80 | 0.5 | 0.050 | 10.9% | 0.011 | 2.4% | 0.010 | 2.3% | 0.052 | 11.4% | |
| High Negative | 80 | 0.7 | 0.042 | 6.0% | 0.000 | 0.0% | 0.017 | 2.4% | 0.045 | 6.4% | ||
| Cut-Off | 80 | 0.9 | 0.061 | 6.7% | 0.000 | 0.0% | 0.018 | 2.0% | 0.064 | 7.0% | ||
| Low Positive | 80 | 1.3 | 0.063 | 5.0% | 0.050 | 4.0% | 0.019 | 1.5% | 0.083 | 6.6% | ||
| Positive | 80 | 2.0 | 0.108 | 5.4% | 0.045 | 2.2% | 0.031 | 1.6% | 0.121 | 6.1% | ||
| Positive | 80 | 3.1 | 0.145 | 4.7% | 0.000 | 0.0% | 0.064 | 2.1% | 0.159 | 5.1% |
BioPlex 2200 Toxo IgM – CLSI EP5-A3 Precision
12
| Within Run | Between Run | Between-Day | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample Type | Rubella IgM | ||||||||||
| Panel Members | N | Mean | |||||||||
| (AI) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Serum | Negative | 80 | 0.3 | 0.011 | 3.7% | 0.000 | 0.0% | 0.000 | 0.0% | 0.011 | 3.7% |
| High Negative | 80 | 0.6 | 0.040 | 6.6% | 0.000 | 0.0% | 0.016 | 2.6% | 0.043 | 7.1% | |
| Cut-Off | 80 | 0.8 | 0.049 | 5.9% | 0.000 | 0.0% | 0.014 | 1.6% | 0.051 | 6.1% | |
| Cut-Off | 80 | 1.1 | 0.066 | 5.8% | 0.000 | 0.0% | 0.031 | 2.7% | 0.073 | 6.4% | |
| Low Positive | 80 | 1.2 | 0.063 | 5.4% | 0.027 | 2.3% | 0.027 | 2.2% | 0.074 | 6.3% | |
| Positive | 80 | 1.5 | 0.085 | 5.7% | 0.039 | 2.6% | 0.000 | 0.0% | 0.094 | 6.2% | |
| Positive | 80 | 2.7 | 0.146 | 5.5% | 0.000 | 0.0% | 0.000 | 0.0% | 0.146 | 5.5% | |
| Positive | 80 | 3.0 | 0.157 | 5.3% | 0.035 | 1.2% | 0.091 | 3.0% | 0.185 | 6.2% | |
| Potassium | |||||||||||
| EDTA | Negative | 80 | 0.3 | 0.011 | 3.7% | 0.000 | 0.0% | 0.000 | 0.0% | 0.011 | 3.7% |
| High Negative | 80 | 0.6 | 0.045 | 7.0% | 0.000 | 0.0% | 0.029 | 4.6% | 0.053 | 8.4% | |
| Cut-Off | 80 | 1.0 | 0.055 | 5.6% | 0.016 | 1.6% | 0.026 | 2.7% | 0.063 | 6.5% | |
| Low Positive | 80 | 1.1 | 0.064 | 5.7% | 0.016 | 1.4% | 0.016 | 1.4% | 0.068 | 6.1% | |
| Positive | 80 | 1.6 | 0.084 | 5.4% | 0.000 | 0.0% | 0.057 | 3.7% | 0.101 | 6.5% | |
| Positive | 80 | 2.4 | 0.118 | 4.9% | 0.000 | 0.0% | 0.084 | 3.5% | 0.145 | 6.0% | |
| Positive | 80 | 3.0 | 0.168 | 5.6% | 0.000 | 0.0% | 0.103 | 3.4% | 0.198 | 6.5% | |
| Sodium Heparin | Negative | 80 | 0.3 | 0.045 | 13.3% | 0.011 | 3.3% | 0.014 | 4.1% | 0.048 | 14.4% |
| High Negative | 80 | 0.6 | 0.042 | 6.8% | 0.011 | 1.8% | 0.023 | 3.7% | 0.049 | 8.0% | |
| Cut-Off | 80 | 1.0 | 0.045 | 4.6% | 0.034 | 3.4% | 0.029 | 2.9% | 0.063 | 6.4% | |
| Low Positive | 80 | 1.1 | 0.066 | 5.8% | 0.016 | 1.4% | 0.018 | 1.6% | 0.070 | 6.2% | |
| Positive | 80 | 1.6 | 0.092 | 5.7% | 0.000 | 0.0% | 0.044 | 2.7% | 0.102 | 6.3% | |
| Positive | 80 | 2.5 | 0.123 | 4.9% | 0.039 | 1.5% | 0.036 | 1.4% | 0.134 | 5.3% | |
| Positive | 80 | 3.2 | 0.155 | 4.9% | 0.019 | 0.6% | 0.029 | 0.9% | 0.159 | 5.0% | |
| Lithium Heparin | Negative | 80 | 0.3 | 0.019 | 6.5% | 0.000 | 0.0% | 0.000 | 0.0% | 0.019 | 6.5% |
| High Negative | 80 | 0.6 | 0.047 | 8.3% | 0.000 | 0.0% | 0.023 | 4.1% | 0.053 | 9.2% | |
| Cut-Off | 80 | 1.0 | 0.063 | 6.6% | 0.000 | 0.0% | 0.032 | 3.3% | 0.071 | 7.4% | |
| Low Positive | 80 | 1.2 | 0.079 | 6.6% | 0.000 | 0.0% | 0.027 | 2.2% | 0.083 | 7.0% | |
| Positive | 80 | 1.5 | 0.089 | 5.9% | 0.047 | 3.1% | 0.026 | 1.7% | 0.105 | 6.8% | |
| Positive | 80 | 2.6 | 0.158 | 6.1% | 0.000 | 0.0% | 0.000 | 0.0% | 0.158 | 6.1% | |
| Positive | 80 | 3.1 | 0.150 | 4.8% | 0.070 | 2.2% | 0.039 | 1.3% | 0.170 | 5.5% |
BioPlex 2200 Rubella IgM – CLSI EP5-A3 Precision
13
| Within Run | Between Run | Between-Day | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample Type | CMV IgM Panel | ||||||||||
| Members | N | Mean | |||||||||
| (AI) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Serum | Negative | 80 | 0.4 | 0.039 | 10.3% | 0.019 | 5.2% | 0.005 | 1.5% | 0.044 | 11.6% |
| High Negative | 80 | 0.8 | 0.060 | 7.5% | 0.000 | 0.0% | 0.017 | 2.2% | 0.063 | 7.8% | |
| Cut-Off | 80 | 1.1 | 0.065 | 6.1% | 0.030 | 2.8% | 0.032 | 3.0% | 0.078 | 7.4% | |
| Cut-Off | 80 | 1.2 | 0.152 | 12.2% | 0.000 | 0.0% | 0.000 | 0.0% | 0.152 | 12.2% | |
| Low Positive | 80 | 1.2 | 0.089 | 7.2% | 0.000 | 0.0% | 0.000 | 0.0% | 0.089 | 7.2% | |
| Positive | 80 | 1.7 | 0.122 | 7.0% | 0.000 | 0.0% | 0.000 | 0.0% | 0.122 | 7.0% | |
| Positive | 80 | 3.0 | 0.196 | 6.6% | 0.000 | 0.0% | 0.030 | 1.0% | 0.198 | 6.7% | |
| Positive | 80 | 3.1 | 0.214 | 7.0% | 0.000 | 0.0% | 0.077 | 2.5% | 0.227 | 7.4% | |
| Potassium | |||||||||||
| EDTA | Negative | 80 | 0.3 | 0.047 | 13.8% | 0.000 | 0.0% | 0.022 | 6.5% | 0.052 | 15.3% |
| High Negative | 80 | 0.8 | 0.047 | 6.2% | 0.030 | 3.9% | 0.015 | 1.9% | 0.058 | 7.5% | |
| Cut-Off | 80 | 1.1 | 0.070 | 6.5% | 0.000 | 0.0% | 0.028 | 2.6% | 0.075 | 7.0% | |
| Low Positive | 80 | 1.3 | 0.089 | 6.7% | 0.000 | 0.0% | 0.000 | 0.0% | 0.089 | 6.7% | |
| Positive | 80 | 1.9 | 0.128 | 6.8% | 0.000 | 0.0% | 0.078 | 4.1% | 0.150 | 8.0% | |
| Positive | 80 | 3.1 | 0.185 | 6.0% | 0.000 | 0.0% | 0.088 | 2.9% | 0.205 | 6.7% | |
| Positive | 80 | 2.9 | 0.196 | 6.7% | 0.000 | 0.0% | 0.122 | 4.2% | 0.231 | 7.9% | |
| Sodium Heparin | Negative | 80 | 0.3 | 0.022 | 7.5% | 0.000 | 0.0% | 0.000 | 0.0% | 0.022 | 7.5% |
| High Negative | 80 | 0.8 | 0.065 | 7.8% | 0.000 | 0.0% | 0.000 | 0.0% | 0.065 | 7.8% | |
| Cut-Off | 80 | 0.8 | 0.047 | 6.3% | 0.022 | 3.0% | 0.017 | 2.3% | 0.055 | 7.3% | |
| Low Positive | 80 | 1.3 | 0.083 | 6.2% | 0.019 | 1.4% | 0.000 | 0.0% | 0.085 | 6.3% | |
| Positive | 80 | 2.0 | 0.121 | 6.0% | 0.000 | 0.0% | 0.048 | 2.4% | 0.130 | 6.5% | |
| Positive | 80 | 3.1 | 0.193 | 6.2% | 0.000 | 0.0% | 0.064 | 2.1% | 0.203 | 6.5% | |
| Positive | 80 | 3.1 | 0.167 | 5.4% | 0.000 | 0.0% | 0.076 | 2.5% | 0.184 | 6.0% | |
| Lithium Heparin | Negative | 80 | 0.3 | 0.040 | 14.2% | 0.000 | 0.0% | 0.000 | 0.0% | 0.040 | 14.2% |
| High Negative | 80 | 0.7 | 0.060 | 8.8% | 0.000 | 0.0% | 0.022 | 3.3% | 0.064 | 9.4% | |
| Cut-Off | 80 | 1.0 | 0.085 | 8.7% | 0.000 | 0.0% | 0.037 | 3.7% | 0.093 | 9.5% | |
| Low Positive | 80 | 1.4 | 0.104 | 7.5% | 0.000 | 0.0% | 0.055 | 4.0% | 0.118 | 8.5% | |
| Positive | 80 | 1.9 | 0.133 | 7.1% | 0.019 | 1.0% | 0.042 | 2.2% | 0.140 | 7.6% | |
| Positive | 80 | 3.0 | 0.222 | 7.5% | 0.096 | 3.2% | 0.000 | 0.0% | 0.242 | 8.1% | |
| Positive | 80 | 2.7 | 0.153 | 5.7% | 0.030 | 1.1% | 0.000 | 0.0% | 0.156 | 5.8% |
BioPlex 2200 CMV IgM – CLSI EP5-A3 Precision
14
Reproducibility Studies:
A reproducibility panel, consisting of six (6) panel members made using serum matrix and BioPlex ToRC IgM OC controls was prepared by Bio-Rad Laboratories. The serum sample panel includes one (1) low negative, one (1) high negative, one (1) low positive near cut-off, one (1) medium positive, and one (1) high positive sample, and one (1) positive control for all three (3) analytes. Reproducibility testing was performed at three (3) US testing facilities using one (1) lot of the BioPlex 2200 ToRC IgM Pack, one (1) lot of BioPlex 2200 ToRC IgM Calibrator Set and one (1) lot of BioPlex 2200 ToRC IgM Control Set. The panels were provided to each of the testing sites. Each of the panel members and control sets were tested in replicates of four (4) on two runs per day over five (5) days at three (3) sites (4 replicates x 2 run x 5 days x 3 Sites = 120 replicates per panel member). The data were analyzed for withinrun (repeatability), between-run, between-day, between-site and total precision according to the principles described in Clinical Laboratory Standards Institute (CLSI) EP15-A3. The grand mean, standard deviation (SD) and percent coefficient of variation (% CV) were calculated. SD was evaluated for samples with AI values 0.8.
| T. gondii IqM | Mean | Within Run | Between Run | Between Day | Between Site | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Panel Member | (AI) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Positive Control | 2.0 | 0.092 | 4.7% | 0.103 | 5.2% | 0.000 | 0.0% | 0.178 | 9.0% | 0.225 | 11.4% |
| Low Negative | 0.2 | 0.029 | 13.8% | 0.016 | 7.6% | 0.000 | 0.0% | 0.010 | 4.7% | 0.035 | 16.5% |
| High Negative | 0.8 | 0.040 | 4.8% | 0.012 | 1.5% | 0.028 | 3.3% | 0.100 | 12.0% | 0.112 | 13.4% |
| Low Positive | 1.3 | 0.051 | 4.0% | 0.032 | 2.5% | 0.023 | 1.8% | 0.148 | 11.6% | 0.162 | 12.7% |
| Mid Positive | 2.2 | 0.081 | 3.7% | 0.058 | 2.6% | 0.032 | 1.5% | 0.257 | 11.7% | 0.278 | 12.7% |
| High Positive | 3.2 | 0.172 | 5.3% | 0.093 | 2.9% | 0.043 | 1.3% | 0.280 | 8.7% | 0.344 | 10.7% |
BioPlex 2200 Toxo IgM - CLSI EP15-A3 Reproducibility
BioPlex 2200 Rubella IgM - CLSI EP15-A3 Reproducibility
| Rubella IgM | Mean | Within Run | Between Run | Between Day | Between Site | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Panel Member | (AI) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Positive Control | 1.9 | 0.086 | 4.5% | 0.053 | 2.8% | 0.043 | 2.3% | 0.198 | 10.5% | 0.227 | 12.0% |
| Low Negative | 0.3 | 0.026 | 9.3% | 0.013 | 4.7% | 0.000 | 0.0% | 0.042 | 15.3% | 0.051 | 18.5% |
| High Negative | 0.8 | 0.048 | 6.2% | 0.000 | 0.0% | 0.026 | 3.3% | 0.097 | 12.4% | 0.111 | 14.2% |
| Low Positive | 1.2 | 0.056 | 4.8% | 0.019 | 1.7% | 0.000 | 0.0% | 0.143 | 12.3% | 0.155 | 13.3% |
| Mid Positive | 1.5 | 0.051 | 3.5% | 0.014 | 1.0% | 0.027 | 1.8% | 0.197 | 13.6% | 0.206 | 14.2% |
| High Positive | 2.8 | 0.139 | 4.9% | 0.015 | 0.5% | 0.030 | 1.1% | 0.328 | 11.6% | 0.358 | 12.6% |
BioPlex 2200 CMV IgM - CLSI EP15-A3 Reproducibility
| CMV IgM Panel
Member | Mean
(AI) | Within Run | | Between Run | | Between Day | | Between Site | | Total | |
|-------------------------|--------------|------------|------|-------------|------|-------------|------|--------------|-------|-------|-------|
| | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Positive Control | 2.3 | 0.098 | 4.3% | 0.053 | 2.4% | 0.058 | 2.6% | 0.145 | 6.4% | 0.192 | 8.5% |
| Low Negative | 0.3 | 0.032 | 9.1% | 0.000 | 0.0% | 0.013 | 3.8% | 0.052 | 15.1% | 0.063 | 18.1% |
| High Negative | 0.7 | 0.048 | 7.0% | 0.011 | 1.6% | 0.009 | 1.3% | 0.062 | 9.0% | 0.080 | 11.6% |
| Low Positive | 1.2 | 0.071 | 6.2% | 0.029 | 2.5% | 0.000 | 0.0% | 0.096 | 8.3% | 0.123 | 10.6% |
| Mid Positive | 1.7 | 0.081 | 4.7% | 0.021 | 1.3% | 0.038 | 2.3% | 0.208 | 12.2% | 0.227 | 13.4% |
| High Positive | 2.9 | 0.146 | 5.1% | 0.026 | 0.9% | 0.065 | 2.3% | 0.257 | 9.0% | 0.304 | 10.6% |
15
b. Linearity/assay reportable range:
Not Applicable.
Traceability, Stability, Expected values (controls, calibrators, or methods) C.
Calibrator Traceability
The BioPlex ToRC IgM calibrators are traceable against frozen internal standards which are anchored to a quantitation panel. The quantitation panel consists of patient samples whose analyte values span the assay range.
The BioPlex 2200 ToRC IgM Reagent Kit is calibrated using a set of two distinct serum based calibrators. A negative and multianalyte T. gondii, Rubella CMV IgM calibrator is used to calibrate the T. gondii, Rubella and CMV IgM assays. The cut-off value and assignment of the calibrators are determined by determining the 98-99th percentile on normal samples and performing concordance and Receiver Operator Characteristic (ROC) analysis during feasibility and development.
The manufacturing target ranges of the Calibrator Set are listed below.
| Calibrator Set | Range (AI) |
|---|---|
| Calibrator Level 1 | 0.0 - 0.2 |
| Calibrator Level 2 | 1.1 - 2.0 |
Controls
The control set includes two vials each of negative control, multianalyte T. gondii, Rubella and CMV IgM. The positive controls contain known concentrations of human T. gondii, Rubella and CMV IgM, and are prepared by blending human disease state serum (T. gondii and CMV) and human recombinant Rubella IgM (huCal) with ToRC IgM negative serum matrix.
The assignment for the BioPlex 2200 ToRC IgM Control Set is performed using a minimum of two reagent lots along with matched calibrators with a target of three reagent lots with matched calibrators. For each control lot, three vials per control level are tested in replicates of five on all reagent lots for a total of fifteen replicates per reagent lot. This testing is performed on three analyzers yielding a total of forty-five replicates per reagent lot. The total number of replicates for each control level is 90 when two reagent lots are used and 135 when three reagent lots are used.
The manufacturing target ranges of the Control Set are listed below.
| Control Set | Range (AI) |
|---|---|
| Negative | |
| Control | 0.0 - 0.5 |
| Positive Control | 2.0 - 2.6 |
Kit Stability
16
BioPlex 2200 ToRC IgM Kit: Real Time (unopened) Kit Stability, 12 months or until the date of expiration when stored unopened on the instrument or at 2 to 8℃; the open kit claim is 60 days.
Calibrator and Control Stability
BioPlex 2200 ToRC IgM Control and Calibrator Sets:
Calibrator Open Vial Stability (2 to 8°C), 60 days from first opening; Control Open Vial Stability (2 to 8℃), 60 days from first opening: Onboard Calibration Curve Stability, 30 days: Real Time Stability of calibrators and controls (2 to 8℃), 12 months; labeled as until expiration date; Calibrators and Controls Accelerated Stability (2 to 8℃), 18 months predicted. Calibrators and Controls Freeze-thaw (-20℃ or -70℃), 5 freeze thaw cycles.
Sample Stability
Serum or plasma (K3 EDTA, lithium heparin, or sodium heparin) samples may be stored at room temperature (18 - 30℃) for up to 3 days and under refrigeration (2 - 8℃) for up to 7 days. For longer storage of samples, keep at -20°C or colder. Up to 5-freeze thaw cycles at -20℃ and -70℃ is acceptable.
- d. Detection limit: Not Applicable.
- e. Analytical specificity:
Cross Reactivity:
The study was conducted to determine if samples from various disease states interfere with test results when tested with the BioPlex 2200 ToRC IgM kit. A panel of at least ten (10) specimens that are positive for each cross reactant were evaluated for possible cross reactivity with the BioPlex 2200 ToRC IgM kit for each of the three antibody assays. The cross reactive samples were tested in commercially available predicate kits in order to confirm their negative status for the target analyte.
Cross reactivity, expressed as percent negative agreement is calculated by the ratio of the number of negative results to the total number of samples assayed for each cross reactant set of samples The results of each potential cross reactant are listed below.
| T. gondii IgM | Rubella IgM | CMV IgM | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Potential Cross Reactant | N | Neg | Pos | N | Neg | Pos | N | Neg | Pos | ||
| ANA Screen | 19 | 19 | 0 | 19 | 19 | 0 | 19 | 19 | 0 | ||
| CMV IgM | 10 | 10 | 0 | 10 | 10 | 0 | N/A | N/A | 0 | ||
| EBV IgM | 11 | 11 | 0 | 11 | 11 | 0 | 11 | 11 | 0 | ||
| HAMA | 15 | 15 | 0 | 15 | 15 | 0 | 15 | 15 | 0 | ||
| hCG | 12 | 12 | 0 | 12 | 12 | 0 | 12 | 12 | 0 | ||
| HIV | 10 | 10 | 0 | 10 | 10 | 0 | 10 | 10 | 0 | ||
| HSV-1/2 IgM | 13 | 13 | 0 | 13 | 13 | 0 | 13 | 13 | 0 | ||
| Hypergamma-globulinemia IgM | 21 | 21 | 0 | 21 | 20 | 1 | 21 | 21 | 0 | ||
| Influenza | 18 | 17 | 1 | 18 | 18 | 0 | 18 | 18 | 0 | ||
| Measles IgM | 16 | 16 | 0 | 16 | 16 | 0 | 16 | 16 | 0 | ||
| Mumps IgM | 13 | 12 | 1 | 13 | 13 | 0 | 13 | 13 | 0 |
BioPlex 2200 ToRC IgM Cross Reactivity
17
| Multiple Myeloma | 17 | 17 | 0 | 17 | 17 | 0 | 17 | 17 | 0 |
|---|---|---|---|---|---|---|---|---|---|
| Parvovirus B 19 IgM | 14 | 14 | 0 | 14 | 13 | 1 | 14 | 14 | 0 |
| Rheumatoid Factor | 11 | 11 | 0 | 11 | 11 | 0 | 11 | 11 | 0 |
| Rubella IgM | 16 | 16 | 0 | N/A | N/A | 0 | 16 | 16 | 0 |
| Toxo IgM | N/A | N/A | 0 | 10 | 10 | 0 | 10 | 10 | 0 |
| VZV IgM | 13 | 12 | 1 | 13 | 13 | 0 | 13 | 12 | 1 |
Interfering Substances:
An interfering substances study was conducted to evaluate the potential interference of specific endogenous and exogenous substances with the BioPlex 2200 ToRC IgM kit according to CLSI EP7-A2 guideline.
No significant interference was observed in any of the substances tested. The substances and the maximum levels tested are shown in the table below.
| Substance | Concentration |
|---|---|
| Hemoglobin | ≤ 500 mg/dL |
| Bilirubin (unconjugated) | ≤ 20 mg/dL |
| Bilirubin (conjugated) | ≤ 30 mg/dL |
| Cholesterol | ≤ 500 mg/dL |
| Red Blood Cells | ≤ 0.4% (v/v) |
| Gamma Globulin | ≤ 6 g/dL |
| Triglycerides | ≤ 3300 mg/dL |
| Beta Carotene | ≤ 0.6 mg/dL |
| Protein (total) | ≤ 12 g/dL |
| Ascorbic Acid | ≤ 6 mg/dL |
| Sodium Heparin | ≤ 8000 units/dL |
| Lithium Heparin | ≤ 8000 units/dL |
| EDTA (K2 and K3) | ≤ 800 mg/dL |
18
High dose hook effect: Not Applicable
f. Assay cut-off:
A final cut-off of 1.0 AI was established for the BioPlex 2200 ToRC IgM assay based on an evaluation of 401, 454 and 511 test ordered and retrospective samples for T. gondli, Rubella and CMV IgM, respectively, of which the serological status was determined from the predicate T. gondii, Rubella and CMV IgM assays. The assay will employ an equivocal zone that brackets the cut-off, which results in samples >1.1 AI being positive and T. gondii IgM | 1.02
(0.99 to 1.06) | -0.05
(-0.12 to 0.02) | 0.994 |
| K3 EDTA vs.
Serum | 53 | Rubella IgM | 1.03
(1.00 to 1.06) | -0.02
(-0.08 to 0.05) | 0.994 |
| K3 EDTA vs.
Serum | 60 | CMV IgM | 1.01
(0.97 to 1.05) | -0.02
(-0.10 to 0.05) | 0.989 |
| Lithium
Heparin vs.
Serum | 54 | T. gondii IgM | 1.02
(0.98 to 1.06) | -0.04
(-0.12 to 0.04) | 0.992 |
| | 51 | Rubella IgM | 1.03
(1.00 to 1.06) | -0.02
(-0.08 to 0.04) | 0.995 |
| | 60 | CMV IgM | 0.98
(0.93 to 1.02) | 0.00
(-0.09 to 0.09) | 0.985 |
| Sodium
Heparin vs.
Serum | 54 | T. gondii IgM | 1.03
(0.99 to 1.06) | -0.05
(-0.12 to 0.02) | 0.994 |
| | 51 | Rubella IgM | 1.01
(0.97 to 1.05) | -0.01
(-0.09 to 0.06) | 0.993 |
| | 59 | CMV IgM | 0.99
(0.96 to 1.03) | -0.04
(-0.11 to 0.04) | 0.991 |
3. Clinical studies:
a. Clinical Sensitivity:
19
Not Applicable
- b. Clinical Specificity: Not Applicable
- c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable
- Clinical cut-off: 4. Not Applicable
- ನ. Expected values/Reference range:
Expected values for the BioPlex 2200 ToRC IgM kit are presented by age and gender in the following tables for samples from pregnant women and patients sent to the lab for T. gondli, Rubella or CMV IgM testing. A total of two hundred (200) each of pregnant women samples sent to the lab for T. gondii, Rubella or CMV IgM testing and approximately five hundred (500) each of samples sent to the lab for T. gondii, Rubella or CMV IgM testing were tested.
BioPlex 2200 ToRC IgM Prevalence Results by Age and Gender: Samples from pregnant women who were sent for T.gondii, Rubella, or CMV IgM testing by Age Group
| T. gondii IgM | Rubella IgM | CMV IgM | ||||
|---|---|---|---|---|---|---|
| Age | Pos/Total | % Prevalence | Pos/Total | % Prevalence | Pos/Total | % Prevalence |
| 15-25 | 1/81 | 1.2% | 0/86 | 0.0% | 4/85 | 4.7% |
| 26-35 | 2/98 | 2.0% | 0/93 | 0.0% | 4/100 | 4.0% |
| 36-43 | 0/21 | 0.0% | 0/21 | 0.0% | 0/15 | 0.0% |
| Total | 3/200 | 1.5% | 0/200 | 0.0% | 8/200 | 4.0% |
BioPlex 2200 ToRC IgM Prevalence Results by Age and Gender: Samples from patients who were sent for T.gondii, Rubella, or CMV IgM testing
| Age | Gender | T. gondii IgM | Rubella IgM | CMV IgM | |||
|---|---|---|---|---|---|---|---|
| Pos/Total | % Prevalence | Pos/Total | % Prevalence | Pos/Total | % Prevalence | ||
| T. gondii , Rubella or CMV | |||||||
| IgM | Pos (+) | Eqv | Neg (-) | Total | Pos (+) | ||
| % Agreement | |||||||
| 95% CI | |||||||
| Commercially Available Immunoassay | T.gondii IgM | Pos (+) | 203 | 3 | 3 | 209 | 97.1% (203/209) |
| 93.9 to 98.7% | |||||||
| Eqv | 1 | 0 | 0 | 1 | |||
| Neg (-) | 0 | 0 | 0 | 0 | |||
| Total | 204 | 3 | 3 | 210 | |||
| Rubella IgM | Pos (+) | 96 | 1 | 1 | 98 | 98.0% (96/98) | |
| 92.9 to 99.4% | |||||||
| Eqv | 1 | 0 | 0 | 1 | |||
| Neg (-) | 1 | 0 | 1 | 2 | |||
| Total | 98 | 1 | 2 | 101 | |||
| CMV IgM | Pos (+) | 198 | 2 | 1 | 201 | 98.5% (198/201) | |
| 95.7 to 99.5% | |||||||
| Eqv | 4 | 1 | 0 | 5 | |||
| Neg (-) | 4 | 0 | 3 | 7 | |||
| Total | 206 | 3 | 4 | 213 |
Correlation with CDC Evaluation Panels: b.
A correlation study was performed to evaluate the characteristics of the BioPlex 2200 ToRC IgM kit with serum panels provided by the Centers for Disease Control and Prevention (CDC) for T. gondii IgM. The results are presented as a means to convey further information on the performance. This does not imply an endorsement of the BioPlex 2200 ToRC IgM kit by the CDC. Results are presented in the table below.
22
| CDC Panel
T. gondii
IgM | BioPlex T. gondii IgM | | | | Positive
Agreement | Negative
Agreement |
|--------------------------------------|------------------------------|----|---------|-------|-----------------------|-----------------------|
| | Pos (+) | Eq | Neg (-) | Total | | |
| Pos (+) | 32 | 0 | 0 | 32 | 100.0% | 100.0% |
| Neg (-) | 0 | 0 | 65 | 65 | 89.3 to 100.0 | 94.4 to 100.0 |
| Total | 32 | 0 | 65 | 97 | | |
Characteristics of CDC T. gondii Reference Sera (N=97)
- Seroconversion Testing: C.
Commercially available seroconversion panels for T. gondii, Rubella and CMV IgM were tested with the BioPlex 2200 ToRC IgM kit and compared with the predicate commercial method.
BioPlex 2200 ToRC IgM Kit, Comparison to Commercial Method - T. gondii IgM
| Panel | Day | VIDAS Toxo IgM
Index | BioPlex ToRC IgM
Antibody Index (AI) |
|------------------|-----|-------------------------|-----------------------------------------|
| | 0 | 0.24(Neg) | 4.0(Pos) |
| | 16 | 5.80(Pos) | >4.0(Pos) |
| | 23 | 5.38(Pos) | >4.0(Pos) |
| | 27 | 5.24(Pos) | >4.0(Pos) |
| | 30 | 5.04(Pos) | >4.0(Pos) |
| Antibody Systems | 49 | 4.59(Pos) | >4.0(Pos) |
| | 53 | 4.35(Pos) | >4.0(Pos) |
| | 86 | 3.30(Pos) | >4.0(Pos) |
| | 88 | 2.94(Pos) | 3.6(Pos) |
| | 93 | 2.67(Pos) | 3.1(Pos) |
| | 95 | 2.62(Pos) | 2.7(Pos) |
| | 100 | 2.58(Pos) | 2.8(Pos) |
| | 104 | 2.34(Pos) | 2.6(Pos) |
| | 107 | 2.36(Pos) | 2.2(Pos) |
| | 112 | 2.28(Pos) | 2.4(Pos) |
| | 114 | 2.21(Pos) | 2.3(Pos) |
| | 119 | 2.29(Pos) | 2.1(Pos) |
23
| Panel | Day | Rubella IgM | |
|---|---|---|---|
| BioPlex RC IgM | |||
| Antibody Index (AI) | BioPlex ToRC IgM | ||
| Antibody Index (AI) | |||
| Liquicheck - RP011 | 0 | 4.0 (Pos) | >4.0 (Pos) |
| 24 | >4.0 (Pos) | >4.0 (Pos) | |
| 27 | >4.0 (Pos) | >4.0 (Pos) | |
| 31 | 3.6 (Pos) | 3.4 (Pos) | |
| 36 | 2.1 (Pos) | 2.0 (Pos) | |
| 39 | 1.5 (Pos) | 1.4 (Pos) | |
| 43 | 1.0 (Eq) | 1.0 (Eq) | |
| 46 | 0.7 (Neg) | 0.6 (Neg) | |
| 50 | 0.6 (Neg) | 0.5 (Neg) | |
| 53 | 0.3 (Neg) | 0.4 (Neg) | |
| 57 | 0.3 (Neg) | 0.4 (Neg) | |
| 60 | 0.3 (Neg) | 0.3 (Neg) | |
| 64 | 0.2 (Neg) | 0.2 (Neg) | |
| 67 | 0.2 (Neg) | 0.2 (Neg) | |
| 71 | 0.2 (Neg) | 0.2 (Neg) |
BioPlex 2200 ToRC IgM Kit, Comparison to Commercial Method – Rubella IgM
24
| Panel | Day | CMV IgM | |
|---|---|---|---|
| BioPlex RC IgM | |||
| Antibody Index (AI) | BioPlex ToRC IgM | ||
| Antibody Index (AI) | |||
| Liquicheck - RP003 | 1 | >4.0 (Pos) | 2.8 (Pos) |
| 4 | >4.0 (Pos) | >4.0 (Pos) | |
| 8 | >4.0 (Pos) | >4.0 (Pos) | |
| 51 | 1.9 (Pos) | 2.3 (Pos) | |
| 55 | 1.8 (Pos) | 2.1 (Pos) | |
| 59 | 1.2 (Pos) | 1.8 (Pos) | |
| 65 | 1.3 (Pos) | 1.5 (Pos) | |
| 67 | 1.4 (Pos) | 1.5 (Pos) | |
| 72 | 1.3 (Pos) | 1.1 (Pos) | |
| 74 | 1.1 (Pos) | 1.0 (Eq) | |
| 79 | 1.6 (Pos) | 1.2 (Pos) | |
| 84 | 1.4 (Pos) | 1.3 (Pos) | |
| 88 | 1.3 (Pos) | 1.4 (Pos) | |
| 95 | 1.3 (Pos) | 1.1 (Pos) | |
| 99 | 1.4 (Pos) | 1.0 (Eq) |
BioPlex 2200 ToRC IgM Kit, Comparison to Commercial Method -CMV IgM
d. IgM Specificity:
Samples positive for T. gondii, Rubella and CMV IgM and IgG were treated with dithiothreitol (DTT) to inactivate IgM activity. The samples were assayed neat and diluted into assay range in replicates of two. IgM was measured using the BioPlex 2200 ToRC IgM kit.
| Sample ID | T. gondii IgM (AI) Before DTT | DTT Treatment Al
(% recovery) |
|-----------|--------------------------------------|----------------------------------|
| Sample 1 | 9.5 | 0.1 (1.05%) |
| Sample 2 | 9.5 | 0.1 (1.05%) |
| Sample 3 | 18.0 | 0.3 (1.67%) |
| Sample 4 | 15.5 | 0.5 (3.23%) |
| Sample 5 | 9.0 | 0.1 (1.11%) |
| Sample 6 | 14.0 | 0.2 (1.43%) |
| Sample 7 | 14.0 | 0.1 (0.71%) |
| Sample 8 | 15.0 | 0.1 (0.67%) |
| Sample 9 | 15.0 | 0.1 (0.67%) |
| Sample 10 | 16.5 | 0.1 (0.61%) |
BioPlex ToRC IgM - T. gondii IgM Specificity
25
| Sample ID | Rubella IgM (AI) Before DTT | DTT Treatment Al
(% recovery) |
|-----------|-----------------------------|----------------------------------|
| Sample 1 | 8.0 | 0.1 (1.25%) |
| Sample 2 | 9.0 | 0.0 (0.00%) |
| Sample 3 | 8.5 | 0.0 (0.00%) |
| Sample 4 | 5.0 | 0.1 (2.00%) |
| Sample 5 | 9.0 | 0.1 (1.11%) |
| Sample 6 | 7.0 | 0.1 (1.43%) |
| Sample 7 | 4.0 | 0.0 (0.00%) |
| Sample 8 | 5.0 | 0.0 (0.00%) |
| Sample 9 | 9.0 | 0.2 (2.22%) |
| Sample 10 | 6.0 | 0.1 (1.67%) |
BioPlex ToRC IgM – Rubella IgM Specificity
BioPlex ToRC IgM – CMV IgM Specificity
| Sample ID | CMV IgM (Al) Before DTT | DTT Treatment Al
(% recovery) |
|-----------|-------------------------|----------------------------------|
| Sample 1 | 25.0 | 0.1 (0.40%) |
| Sample 2 | 11.0 | 0.2 (1.82%) |
| Sample 3 | 8.5 | 0.1 (1.18%) |
| Sample 4 | 20.0 | 0.5 (2.50%) |
| Sample 5 | 15.5 | 0.2 (1.29%) |
| Sample 6 | 18.5 | 0.2 (1.08%) |
| Sample 7 | 21.0 | 0.2 (0.95%) |
| Sample 8 | 6.0 | 0.0 (0.00%) |
| Sample 9 | 16.5 | 1.2 (7.27%) |
| Sample 10 | 31.5 | 0.7 (2.22%) |