(133 days)
No
The device description and performance studies detail a standard ELISA assay and its analytical and clinical performance, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: This device is an in vitro diagnostic test kit designed to detect antibodies to Borrelia burgdorferi for the diagnosis of Lyme disease. It does not provide any therapeutic benefit or treatment.
Yes
The device is explicitly described as a "qualitative test for the detection of IgG and IgM antibodies to Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection." This aligns with the definition of a diagnostic device, which is used to identify a disease or condition.
No
The device description clearly outlines a physical kit containing reagents, controls, and strips for performing an ELISA test, which is a laboratory-based assay involving chemical reactions and photometric reading. This is a hardware-based diagnostic test kit, not a software-only device.
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 device is a "qualitative test for the detection of IgG and IgM antibodies to Borrelia burgdorferi sensu stricto in human serum". This indicates that the device is used to examine specimens derived from the human body (serum) to provide information for the diagnosis of a disease (Lyme disease).
- Device Description: The description details the components of the kit and the procedure for performing the test on human serum samples. This aligns with the nature of an in vitro diagnostic device, which is used outside of the body to analyze biological samples.
- Performance Studies: The document includes detailed descriptions of nonclinical and clinical studies conducted to evaluate the performance of the device using human serum samples. This is a standard requirement for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device(s): The mention of predicate devices with K numbers (K033070, K113847, K113846) indicates that this device is being compared to previously cleared IVD devices.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative test for the detection of IgG and IgM antibodies to Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be confirmed through additional testing by one of the following methods:
• Standard two-tier test methodology (STTT) using an IgG and/or IgM blot testing following current interpretation guidelines, OR
• Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
Product codes
LSR
Device Description
The kit includes 12 x 8 well Antigen Coated strips, Conjugate, Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.
During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients' serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test kit is a combination of B. burgdorferi sensu stricto strain B31 lysate, B. burgdorferi sensu stricto strain 2591 lysate, and a recombinant VlsE from B. burgdorferi sensu stricto strain B31. The lysates use spirochetes growing in BSK-H complete medium until mid-exponential phase. The recombinant VlsE protein is produced in E. coli SURE2 cells and purified by affinity chromatography. The purity of each antigen is assayed by SDS-PAGE followed by Coomassie staining and/or Western blotting.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Studies: Determination of the Assay Cutoff
- Sample Size: 200 normal sera (100 from endemic region, 100 from non-endemic region) plus 125 characterized Lyme disease samples. Total of 325 samples.
- Data Source: Endemic and non-endemic regions for normal sera; characterized Lyme disease samples.
- Annotation Protocol: Normal sera were used to calculate the mean plus two standard deviations to determine the assay cutoff. A known positive sample was diluted to produce a ready-to-use cutoff control. An ROC analysis was generated with the 325 samples to verify the chosen cutoff.
- Key Results: The analysis confirmed that the assay cutoff provided an optimal level of sensitivity and specificity.
Nonclinical Studies: Precision
- Study Type: Within-lab precision study.
- Sample Size: A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with kit controls. Each panel member was tested in duplicate, twice per day, for 12 days.
- Key Results: Results summarized in a table showing SD and CV for within-run, between-run, between-day, and total for each sample type. For Moderate Positive, Total CV was 8.9%. For Low Positive, Total CV was 11.9%. For High Negative, Total CV was 11.4%. For Negative, Total CV was 11.6%.
Nonclinical Studies: Reproducibility
- Study Type: Reproducibility study at three different sites.
- Sample Size: A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with kit controls. Each panel member was tested in triplicate, twice per day, for five days.
- Key Results: Results summarized in a table showing SD and CV for within-run, between-run, between-day, between-sites, and total for each sample type. For Moderate Positive, Total CV was 9.0%. For Low Positive, Total CV was 9.4%. For High Negative, Total CV was 12.8%. For Negative, Total CV was 23.0%.
Nonclinical Studies: Analytical Specificity
- Study Type: Evaluation of analytical specificity.
- Sample Size: 210 asymptomatic individuals' samples (110 from endemic region, 100 from non-endemic region).
- Key Results: Analytical Specificity for Endemic Region: 97.3%. Analytical Specificity for Non-endemic Region: 98.0%.
Nonclinical Studies: Cross Reactivity
- Study Type: Evaluation of potential cross-reactivity from different disease conditions.
- Sample Size: 221 samples from serum vendors confirmed positive for respective markers.
- Key Results: Summary table showing number of positive/percentage for various infections/diagnoses. For example, Tick-borne Relapsing Fever (2/7.7%), Treponemal Infections (2*/8.7%), Fibromyalgia (1/10%). Most other conditions showed 0% positivity. (*Also positive on the predicate device)
Nonclinical Studies: Interfering Substances
- Study Type: Evaluation of the effect of potential interfering substances.
- Sample Size: Three samples (negative, low positive, moderate positive) spiked with high levels of interferants, and corresponding unspiked serum.
- Key Results: The tested substances (Albumin, Bilirubin, Cholesterol, Hemoglobin, Triglycerides) did not affect the performance.
Clinical Studies: Comparison with Predicate Device (STTT)
- Study Type: Comparison study.
- Sample Size: 520 serum samples.
- Data Source: Prospective samples submitted for Lyme serology testing at three sites (one internal, two external).
- Key Results:
- Positive percent agreement = 96.0% (72/75) with 95% CI (88.8% - 99.2%)
- Negative percent agreement = 97.5% (434/445) with 95% CI (95.6% - 98.8%)
Clinical Studies: Sensitivity Study (STTT)
- Study Type: Sensitivity study.
- Sample Size: 89 clinically characterized samples.
- Key Results:
- Early stage: 76.3% (29/38) for Subject Device, 78.9% (30/38) for Predicate.
- Disseminated stage: 100.0% (15/15) for both devices.
- Late stage: 97.2% (35/36) for Subject Device, 94.4% (34/36) for Predicate.
Clinical Studies: CDC Panel (STTT)
- Study Type: Panel testing.
- Sample Size: 40 samples (5 healthy, 35 Lyme disease patients stratified by disease stage) from CDC.
- Key Results:
- Healthy: 100.0% agreement for both (0 positive/equivocal).
- Early (0-2 months): 86.7% (13/15) for Subject Device, 80.0% (12/15) for Predicate.
- Convalescent (3-12 months): 53.8% (7/13) for both.
- Late (>1 year): 100.0% (7/7) for both.
Clinical Studies: Prospective Study (MTTT)
- Study Type: Comparison study of MTTT vs. STTT.
- Sample Size: 481 serum samples for first-tier testing; 54 positive/equivocal samples for second-tier testing.
- Data Source: Prospective samples from three sites.
- Key Results:
- Second-tier comparison (n=54): Positive percent agreement = 100.0% (36/36) with 95% CI (90.3% - 100.0%); Negative percent agreement = 27.8% (5/18) with 95% CI (9.7% - 53.5%).
- Full study comparison (n=481): Positive percent agreement = 100.0% (36/36) with 95% CI (90.3% - 100.0%); Negative percent agreement = 97.1% (432/445) with 95% CI (95.1% - 98.4%).
Clinical Studies: Sensitivity Study (MTTT)
- Study Type: Sensitivity study.
- Sample Size: 125 clinically characterized samples.
- Key Results:
- Early stage: 61.3% (38/62) for Subject MTTT, 62.9% (39/62) for Predicate STTT.
- Disseminated stage: 90.9% (20/22) for both.
- Late stage: 97.6% (40/41) for both.
Clinical Studies: CDC Reference Panel (MTTT)
- Study Type: Panel testing.
- Sample Size: 280 positive and negative specimens from CDC.
- Key Results:
- Healthy: 100.0% agreement for both (0 positive/equivocal).
- Early Lyme: 76.7% (46/60) for Subject MTTT, 61.7% (37/60) for Predicate STTT.
- Cardiac Lyme: 66.7% (2/3) for both.
- Neurological Lyme: 85.7% (6/7) for both.
- Late: 100.0% (20/20) for both.
- Look-alike Disease: 98.9% (1/90 positive) for Subject MTTT, 95.6% (4/90 positive) for Predicate STTT.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Analytical Specificity: Endemic Region: 97.3%; Non-endemic Region: 98.0%.
- Comparison (STTT): Positive percent agreement = 96.0%; Negative percent agreement = 97.5%.
- Sensitivity Study (STTT):
- Early: 76.3% (Subject), 78.9% (Predicate)
- Disseminated: 100.0% (Subject & Predicate)
- Late: 97.2% (Subject), 94.4% (Predicate)
- CDC Panel (STTT):
- Healthy: 100.0% (Subject & Predicate)
- Early (0-2 months): 86.7% (Subject), 80.0% (Predicate)
- Convalescent (3-12 months): 53.8% (Subject & Predicate)
- Late (>1 year): 100.0% (Subject & Predicate)
- MTTT Comparison - Prospective Study (Second-tier): Positive percent agreement = 100.0%; Negative percent agreement = 27.8% (Note: This is specifically for second-tier positive/equivocal samples previously found positive in the first-tier).
- MTTT Comparison - Prospective Study (Overall): Positive percent agreement = 100.0%; Negative percent agreement = 97.1%.
- Sensitivity Study (MTTT):
- Early: 61.3% (Subject MTTT), 62.9% (Predicate STTT)
- Disseminated: 90.9% (Subject MTTT & Predicate STTT)
- Late: 97.6% (Subject MTTT & Predicate STTT)
- CDC Reference Panel (MTTT):
- Healthy: 100.0% (Subject MTTT & Predicate STTT)
- Early Lyme: 76.7% (Subject MTTT), 61.7% (Predicate STTT)
- Cardiac Lyme: 66.7% (Subject MTTT & Predicate STTT)
- Neurological Lyme: 85.7% (Subject MTTT & Predicate STTT)
- Late: 100.0% (Subject MTTT & Predicate STTT)
- Look-alike Disease: 98.9% Agreement (Subject MTTT), 95.6% Agreement (Predicate STTT)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
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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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 22, 2021
Gold Standard Diagnostics Jennifer Roth Vice President, Product Development 2851 Spafford St. Davis, California 95618
Re: K203292
Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: November 4, 2020 Received: November 9, 2020
Dear Jennifer Roth:
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,
Maria Ines Garcia, Ph.D. Branch Chief 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) K203292
Device Name
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Indications for Use (Describe)
The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative test for the detection of IgG and IgM antibodies to Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be confirmed through additional testing by one of the following methods:
• Standard two-tier test methodology (STTT) using an IgG and/or IgM blot testing following current interpretation guidelines, OR
• Modified two-tier test methodology (MTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/ IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
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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Image /page/3/Picture/0 description: The image contains the logo for Gold Standard Diagnostics. The logo features the company name in bold, dark blue text, stacked in three lines. To the right of the text is a graphic of three overlapping, stylized hexagons in a gold color. The hexagons are arranged in a way that they appear to be interconnected.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
- Submitter's Name: Gold Standard Diagnostics Address: 620 Cantrill Drive Davis, CA. 95618 Phone Number: 530-759-8000 Contact Person: Jennifer Roth November 4, 2020 Date:
-
- Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Common Name: Lyme ELISA Test
- Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Regulation Section:
(21 CFR 866.3830) Treponema pallidum treponemal test reagents.
Classification: Class II
Product Code: LSR; Reagent, Borrelia Serological Reagent
- Note: This clearance is for a modified use (Modified Two-tier Testing or MTTT use) for the previously cleared IVD test, the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K180264). The information and study data for the modified use is presented under the heading of "MTTT Comparison" below. With the exception of the intended use, all other information and data remain the same.
3) Legally Marketed Device to Which the Submitter Claims Equivalence:
- a. STTT Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA Test Kit (K033070).
- b. MTTT Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test Kit (K113847) and the Gold Standard Diagnostics Borrelia burgdorferi IgM Blot Test Kit (K113846).
4) Description of the Device:
The kit includes 12 x 8 well Antigen Coated strips, Conjugate, Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.
During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody
4
complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG/IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients' serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test kit is a combination of B. burgdorferi sensu stricto strain B31 lysate, B. burgdorferi sensu stricto strain 2591 lysate, and a recombinant VlsE from B. burgdorferi sensu stricto strain B31. The lysates use spirochetes growing in BSK-H complete medium until mid-exponential phase. The recombinant VlsE protein is produced in E. coli SURE2 cells and purified by affinity chromatography. The purity of each antigen is assayed by SDS-PAGE followed by Coomassie staining and/or Western blotting.
5) Intended Use of the Device:
The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is intended as a qualitative test for the detection of IgG and IgM antibodies to Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be confirmed through additional testing by one of the following methods:
- . Standard two-tier test methodology (STTT) using an IgG and/or IgM blot testing following current interpretation guidelines, OR
- Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics . Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IzM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
6) Comparison with the Predicate Device:
The tables below provide a comparison of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test kit with the Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA Test kit (predicate device: K033070) when used as the first-step for the detection of IgG and IgM antibodies to B. burgdorferi in human serum. Positive and equivocal results must be supplemented by testing with a second-step Immunoblot assay.
5
| Similarities | ||
|---|---|---|
| Item | Subject Device: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Predicate Device: Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA Test Kit |
| Intended Use | The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test kit is intended as a qualitative presumptive (first step) test for the detection of IgG and IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay. | Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA Test kit is intended for the qualitative presumptive (first-step) detection of total (IgG/IgM) antibodies to B. burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western-blot (second step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second step) should not be used to exclude Lyme disease. |
| Assay Format | Antigen coated microtiter plate – 96 wells. | Same |
| Technology | ELISA | Same |
| Sample Matrix | Human serum | Same |
| Controls Provided | Positive, Cutoff, Negative | Same |
| Reagents Provided | Diluent, Wash, Conjugate, Substrate, Stop Solution | Same |
| Reported Results | Positive, Equivocal, Negative | Same |
| Interpretation | Optical density readings from Spectrophotometer | Same |
| Differences | ||
|---|---|---|
| Item | Subject Device: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Predicate Device: Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA Test Kit |
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| Sample Processing | Dilute Samples 1:100 in Diluent | Dilute Samples 1:20 in Diluent |
|---|---|---|
| Volumes | 100ul sample, 50ul substrate, 50ul stop solution | 100ul sample, 100ul substrate, 100ul stop solution |
| Incubation | 15/15/15 minutes at room temperature | 25/25/10-15 minutes at room temperature |
| Antigens | B. burgdorferi B31 strain, | |
| B. burgdorferi 2591 strain, | ||
| B. burgdorferi recombinant VlsE | ||
| B31 strain | B. burgdorferi B31 strain | |
| Results Interpretation | Convert to units. | |
| Negative 11.0 | Convert to units. | |
| Negative ≤0.90 | ||
| Equivocal 0.91-1.09 | ||
| Positive ≥1.10 |
6(b1): Nonclinical Studies:
Determination of the Assay Cutoff
The cutoff was determined by testing a total of 200 normal sera which consisted of 100 sera from an endemic region of Lyme disease and 100 sera from a non-endemic region of Lyme disease. The mean plus two standard deviations was used to determine the assay cutoff. A known positive sample was then diluted to produce a ready to use cutoff control. After the cutoff was determined 125 characterized Lyme disease samples were tested. An ROC analysis was then generated with the 325 samples (200 normal and 125 characterized samples) to verify the chosen cutoff. The analysis confirmed that the assay cutoff provided an optimal level of sensitivity and specificity.
Precision
To determine the precision of the Borrelia burgdorferi IgG/IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate, twice per day, for 12 days. The sample panel was masked and randomized. The results are summarized in the following table:
| Sample | N | Mean
Units | | Within-Run | Between-Run | Between-Day | Total |
|----------------------|----|---------------|----|------------|-------------|-------------|-------|
| Moderate
Positive | 48 | 19.6 | SD | 0.815 | 1.534 | 1.472 | 1.737 |
| | | | CV | 4.2% | 7.8% | 7.5% | 8.9% |
| Low
Positive | 48 | 12.1 | SD | 0.267 | 1.417 | 1.248 | 1.442 |
| | | | CV | 2.2% | 11.7% | 10.3% | 11.9% |
| High
Negative | 48 | 6.1 | SD | 0.211 | 0.662 | 0.642 | 0.695 |
| | | | CV | 3.4% | 10.8% | 10.5% | 11.4% |
| Negative | 48 | 1.7 | SD | 0.113 | 0.164 | 0.151 | 0.199 |
| | | | CV | 6.6% | 9.6% | 8.8% | 11.6% |
7
Reproducibilitv
A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The sample panel was masked and randomized. The results are summarized in the following table:
| Sample | N | Mean
Units | | Within-
Run | Between-
Run | Between-
Day | Between-
Sites | Total |
|----------------------|----|---------------|----|----------------|-----------------|-----------------|-------------------|-------|
| Moderate
Positive | 90 | 21.1 | SD | 1.117 | 1.543 | 1.434 | 0.386 | 1.905 |
| | | | CV | 5.3% | 7.3% | 6.8% | 1.8% | 9.0% |
| Low
Positive | 90 | 13.8 | SD | 0.591 | 1.155 | 1.026 | 0.404 | 1.297 |
| | | | CV | 4.3% | 8.4% | 7.5% | 2.9% | 9.4% |
| High
Negative | 90 | 6.4 | SD | 0.323 | 0.756 | 0.715 | 0.237 | 0.822 |
| | | | CV | 5.0% | 11.7% | 11.1% | 3.7% | 12.8% |
| Negative | 90 | 1.6 | SD | 0.145 | 0.335 | 0.312 | 0.347 | 0.365 |
| | | | CV | 9.1% | 21.1% | 19.6% | 21.8% | 23.0% |
Analytical Specificity
The analytical specificity was determined by testing 210 asymptomatic individuals' samples from endemic (Pennsylvania) and non-endemic (Arizona) regions. The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test results are summarized in the following table:
| | Number of Samples | Number
Positive/Equivocal | Analytical Specificity |
|--------------------|-------------------|------------------------------|------------------------|
| Endemic Region | 110 | 3 | 97.3% |
| Non-endemic Region | 100 | 2 | 98.0% |
Cross Reactivity
A study using 221 samples was conducted to evaluate potential cross reactivity from different disease conditions. The samples were obtained from serum vendors who confirmed their positivity for each respective marker. The samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table:
| Infection / Diagnosis | Number of Sera
Tested | # Positive / (%) |
|----------------------------|--------------------------|------------------|
| Tick-borne Relapsing Fever | 26 | 2 / (7.7%) |
| Treponemal Infections | 23 | 2* (8.7%) |
| Rickettsia | 10 | 0 / (0%) |
| Ehrlichiosis | 10 | 0 / (0%) |
| Babesiosis | 11 | 0 / (0%) |
8
| Leptospirosis | 11 | 0 / (0%) |
|---|---|---|
| Parvovirus B19 | 12 | 0 / (0%) |
| Influenza A&B | 10 | 0 / (0%) |
| Epstein-Barr Virus | 10 | 0 / (0%) |
| Cytomegalovirus | 19 | 0 / (0%) |
| H. pylori | 11 | 0 / (0%) |
| Fibromyalgia | 10 | 1/ (10%) |
| Rheumatoid Arthritis | 11 | 0 / (0%) |
| Herpes Simplex Virus | 13 | 0 / (0%) |
| Varicella Zoster Virus | 12 | 0 / (0%) |
| Autoimmune Disease | 22 | 0 / (0%) |
*Also positive on the predicate device
Interfering Substances
The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test was evaluated. Three samples, a negative, a low positive and a moderate positive were spiked with high levels of interferants and were tested along with serum without spiked interferants. The recommended concentrations from the guideline "Interference Testing in Clinical Chemistry EP7-A2" from the Clinical and Laboratory Standards Institute were used (see table below). The tested substances did not affect the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test.
| Substance | Concentration | Interference |
|---|---|---|
| Albumin | 120 g/L | None detected |
| Bilirubin | 342 μmol/L | None detected |
| Cholesterol | 13 mmol/L | None detected |
| Hemoglobin | 2 g/L | None detected |
| Triglycerides | 37 mmol/L | None detected |
6(b2): Clinical Studies:
Comparison with Predicate Device
Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Five hundred and twenty (520) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate B. burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table:
| Predicate IgG/IgM ELISA | |||||
|---|---|---|---|---|---|
| Positive | Equivocal* | Negative | Total | ||
| Gold Standard | |||||
| Diagnostics Borrelia | |||||
| burgdorferi IgG/IgM | |||||
| ELISA Test Kit | Positive | 55 | 7 | 2 | 64 |
| Equivocal* | 8 | 2 | 9 | 19 | |
| Negative | 2 | 1 | 434 | 437 | |
| Total | 65 | 10 | 445 | 520 |
*Equivocal samples counted as positive
9
| Positive percent agreement = 96.0% (72/75) | 95% CI (88.8% - 99.2%) |
|---|---|
| Negative percent agreement = 97.5% (434/445) | 95% CI (95.6% - 98.8%) |
Clinical Sensitivity
Sensitivity Study
A sensitivity study was performed on 89 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate B. burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table:
| Disease
Stage | n | Gold Standard
Diagnostics Borrelia
burgdorferi IgG/IgM
ELISA Test Kit | Predicate
IgG/IgM ELISA |
|------------------|----|--------------------------------------------------------------------------------|----------------------------|
| Early | 38 | 76.3% (29/38) | 78.9% (30/38) |
| Disseminated | 15 | 100.0% (15/15) | 100.0% (15/15) |
| Late | 36 | 97.2% (35/36) | 94.4% (34/36) |
CDC Panel
Forty samples of various reactivity were acquired from the Centers for Disease Control (CDC). Of the 40 samples, five were from healthy individuals and 35 were from patients diagnose with Lyme disease and stratified by disease stage. All samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test and on the predicate Borrelia burgdorferi IgG/IgM ELISA Test. The results are summarized in the following table:
| Disease
Stage | n | Gold Standard Diagnostics
Borrelia burgdorferi
IgG/IgM ELISA Test Kit | | Predicate
IgG/IgM ELISA | |
|-------------------------------|----|------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 5 | 0 | 100.0% | 0 | 100.0% |
| Early
(0-2 months) | 15 | 13 | 86.7% | 12 | 80.0% |
| Convalescent
(3-12 months) | 13 | 7 | 53.8% | 7 | 53.8% |
| Late
(>1 year) | 7 | 7 | 100.0% | 7 | 100.0% |
Expected Values
The range of values and positivity rate among different studies and population for the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test are as follows:
10
| Population | # Samples | Unit Results | Qualitative Results | |||
|---|---|---|---|---|---|---|
| Mean | Range | Std. | ||||
| Dev. | # | |||||
| Positive/ | ||||||
| Equivocal | % | |||||
| Positive/ | ||||||
| Equivocal | ||||||
| Normal | ||||||
| Endemic | 110 | 5.8 | 0.6 - 11.3 | 2.075 | 3 | 2.7% |
| Normal | ||||||
| Non-Endemic | 100 | 4.2 | 0.9 - 12.3 | 2.077 | 2 | 2.0% |
| Prospective | ||||||
| Study | 520 | 6.3 | 0.70 - 32.3 | 5.407 | 83 | 16.0% |
| Sensitivity | ||||||
| Study | 89 | 25.0 | 3.6 - 34.9 | 8.449 | 79 | 88.8% |
Note: It is recommended that each laboratory determine its own normal range based on the population.
7) Conclusion:
From the comparison data, we conclude that the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test is substantially equivalent to the Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA Test kit (predicate device: K033070).
MTTT Comparison:
Comparison with the Predicate Device - MTTT:
The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit, when used as the first-step or second-step test in combination with another Gold Standard Diagnostics Borrelia burgdorferi ELISA Test Kit in the Modified Two-tier Testing (MTTT) method, was compared to the Standard Two-tier testing (STTT) method using the predicates Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA (K180264) Test Kit as the first-step test followed by testing all the positive and equivocal results on the Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test (K113847) and the Gold Standard Diagnostics Borrelia burgdorferi IgM Blot Test (K113846). Below are tables comparing the two devices.
| Similarities | ||||
|---|---|---|---|---|
| Item | Subject Device: Gold | |||
| Standard Diagnostics | ||||
| Borrelia burgdorferi | ||||
| IgG/IgM ELISA Test Kit | Predicate Device: Gold | |||
| Standard Diagnostics | ||||
| Borrelia burgdorferi IgG Blot | ||||
| (K113847) | Predicate Device: Gold | |||
| Standard Diagnostics Borrelia | ||||
| burgdorferi IgM Blot | ||||
| (K113846) | ||||
| Intended Use | The Gold Standard | |||
| Diagnostics Borrelia | ||||
| burgdorferi IgG/IgM ELISA | ||||
| Test Kit is intended as a | ||||
| qualitative test for the | ||||
| detection of IgG and IgM | ||||
| antibodies to Borrelia | ||||
| burgdorferi sensu stricto in | ||||
| human serum from | ||||
| symptomatic patients or | ||||
| people suspected of infection. | The Gold Standard Diagnostics | |||
| Borrelia burgdorferi B31 IgG | ||||
| Line Blot Test Kit is intended | ||||
| for the qualitative detection of | ||||
| IgG antibodies to B. | ||||
| burgdorferi sensu stricto (B31) | ||||
| in human serum. This test is | ||||
| intended for use in testing | ||||
| human serum samples which | ||||
| have been found positive or | The Gold Standard Diagnostics | |||
| Borrelia burgdorferi B31 IgM | ||||
| Line Blot Test Kit is intended | ||||
| for the qualitative detection of | ||||
| IgM antibodies to B. | ||||
| burgdorferi sensu stricto (B31) | ||||
| in human serum. This test is | ||||
| intended for use in testing | ||||
| human serum samples which | ||||
| have been found positive or |
11
| When used as the first-tier
screening test, positive and
equivocal results must be
confirmed through additional
testing by one of the
following methods: | equivocal using an ELISA or
IFA test procedure to provide
supportive evidence of
infection with B. burgdorferi . | equivocal using an ELISA or
IFA test procedure to provide
supportive evidence of infection
with B. burgdorferi . | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------|
| Standard two-tier test
methodology (STTT) using
an IgG and/or IgM blot
testing following current
interpretation guidelines, OR
Modified two-tier test
methodology (MTTT) using
one or more of the following
three ELISA based assays:
• Gold Standard Diagnostics
Borrelia burgdorferi VlsE-
OspC IgG/IgM ELISA Test
• Gold Standard Diagnostics
Borrelia burgdorferi IgG
ELISA Test
• Gold Standard Diagnostics
Borrelia burgdorferi IgM
ELISA Test | | | |
| The assay can also be used as
a second-tier confirmation
test using the MTTT
methodology when used with
one or more of the following
three ELISA based assays:
• Gold Standard Diagnostics
Borrelia burgdorferi VlsE-
OspC IgG/IgM ELISA Test
• Gold Standard Diagnostics
Borrelia burgdorferi IgG
ELISA Test
• Gold Standard Diagnostics
Borrelia burgdorferi IgM
ELISA Test | | | |
| Positive test results by either
the STTT or MTTT
methodology are supportive
evidence for the presence of
antibodies and exposure to
Borrelia burgdorferi , the
cause of Lyme disease. A
diagnosis of Lyme disease
should be made based on the | | | |
| | presence of Borrelia
burgdorferi antibodies,
history, symptoms, and other
laboratory findings. | | |
| Antigens | B. burgdorferi B31 strain, | Same | Same |
| Sample Matrix | Human serum | Same | Same |
| Controls Provided | Positive, Cutoff, Negative | Same | Same |
| Sample Processing | Dilute Samples 1:100 | Same | Same |
| Assay Type | Qualitative | Same | Same |
12
| Differences | |||
|---|---|---|---|
| Item | Subject Device: Gold | ||
| Standard Diagnostics Borrelia | |||
| burgdorferi IgG/IgM ELISA | |||
| Test Kit | Predicate Device: Gold | ||
| Standard Diagnostics Borrelia | |||
| burgdorferi IgG Blot | |||
| (K113847) | Predicate Device: Gold | ||
| Standard Diagnostics | |||
| Borrelia burgdorferi IgM Blot | |||
| (K113846) | |||
| Assay Format | Antigen coated microtiter plate |
- 96 wells. | Nitrocellulose Strips | Nitrocellulose Strips |
| Reagents
Provided | Diluent, Wash, Conjugate,
Substrate, Stop Solution | Diluent/Wash, Conjugate,
Substrate | Diluent/Wash, Conjugate,
Substrate |
| Volumes | 100ul sample, 50ul substrate,
50ul stop solution | 1500ul sample, 1500ul
substrate | 1500ul sample, 1500ul
substrate, |
| Incubation | 15/15/15 minutes at room
temperature | 30/30/10-13 minutes at room
temperature | 30/30/10-13 minutes at room
temperature |
| Interpretation | Optical density readings from
Spectrophotometer | Visual | Visual |
| Results
Interpretation | Convert to units.
Negative 11.0 | Compare to cutoff band | Compare to cutoff band |
| Reported
Results | Positive, Equivocal, Negative | Positive, Negative | Positive, Negative |
Method Comparison MTTT - IgG/IgM
The following studies were conducted to determine the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test as a first-tier or second-tier assay in the modified two-tier testing (MTTT) methodology.
Gold Standard Diagnostics MTTT-IgG/IgM ELISA Method Comparison: The Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test was utilized in a MTTT (2-ELISA) protocol with the Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test. The MTTT (2-ELISA) results were compared to the standard two-tier testing (STTT) using the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA followed by testing all positive and equivocal results on the predicate Gold Standard Diagnostics Borrelia burgdorferi IgG blot test and Gold Standard Diagnostics Borrelia burgdorferi IgM blot test.
13
Prospective Study
Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Four hundred eighty-one (481) serum samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test. A total of 54 positive and equivocal samples were obtained.
In the STTT protocol the samples that were positive or equivocal (n=54) were tested with B. burgdorferi IgG and IgM blot tests. In the MTTT protocol the samples (n=54) were tested on a second ELISA, the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test. In the second-tier ELISA test, positive and equivocal results were considered positive.
The results of the second-tier test of the STTT when compared to the second-tier test of the MTTT, including only the samples that were positive in the first tier, are summarized in the following table:
| | | Predicate IgG & IgM
Immunoblots | | |
|----------------------------------------------------------------------------------------------|----------|------------------------------------|----------|-------|
| | | Positive | Negative | Total |
| Gold Standard Diagnostics
Borrelia burgdorferi VlsE -
OspC IgG/IgM ELISA | Positive | 36 | 13 | 49 |
| Gold Standard Diagnostics
Borrelia burgdorferi VlsE -
OspC IgG/IgM ELISA | Negative | 0 | 5 | 5 |
| Gold Standard Diagnostics
Borrelia burgdorferi VlsE -
OspC IgG/IgM ELISA | Total | 36 | 18 | 54 |
Positive percent agreement = 100.0% Negative percent agreement = 27.8% 95% CI (90.3% - 100.0%) 95% CI (9.7% - 53.5%)
The results of the MTTT when compared to the STTT, including all samples that were part of the prospective study (n=481), are summarized in the following table:
| Predicate STTT- IgG/IgM | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Gold Standard Diagnostics | ||||
| MTTT- IgG/IgM | Positive | 36 | 13 | 49 |
| Negative | 0 | 432 | 432 | |
| Total | 36 | 445 | 481 |
Positive percent agreement = 100.0% Negative percent agreement = 97.1%
95% CI (90.3% - 100.0%) 95% CI (95.1% - 98.4%)
Sensitivity Study
A sensitivity study was performed on 125 clinically characterized samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics MTTT-IgG/IgM and on the predicate STTT-IgG/IgM. The results are summarized in the following table:
14
| Disease
Stage | n | Gold Standard Diagnostics
MTTT – IgG/IgM | | Predicate
STTT - IgG/IgM | |
|------------------|----|---------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Early | 62 | 38 | 61.3% | 39 | 62.9% |
| Disseminated | 22 | 20 | 90.9% | 20 | 90.9% |
| Late | 41 | 40 | 97.6% | 40 | 97.6% |
CDC Reference Panel
A panel of 280 positive and negative specimens from the Centers of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics MTTT-IgG/IgM and on the predicate STTT-IgG/IgM. The results are summarized in the following table:
| Disease Stage | n | Gold Standard Diagnostics MTTT-IgG/IgM | Predicate STTT- IgG/IgM | ||
|---|---|---|---|---|---|
| Positive or Equivocal | % Agreement with Clinical Diagnosis | Positive or Equivocal | % Agreement with Clinical Diagnosis | ||
| Healthy | 100 | 0 | 100.0% | 0 | 100.0% |
| Early Lyme | 60 | 46 | 76.7% | 37 | 61.7% |
| Cardiac Lyme | 3 | 2 | 66.7% | 2 | 66.7% |
| Neurological Lyme | 7 | 6 | 85.7% | 6 | 85.7% |
| Late | 20 | 20 | 100.0% | 20 | 100.0% |
| Look-alike Disease* | 90 | 1 | 98.9% | 4 | 95.6% |
*infectious mononucleosis, fibromyalgia, multiple sclerosis, rheumatoid arthritis, syphilis and severe periodontitis
8) Conclusion:
From the comparison data, we conclude that the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test is substantially equivalent to the Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test Kit (K113847) and the Gold Standard Diagnostics Borrelia burgdorferi IgM Blot Test Kit (K113846) when used for the Modified Two-tier Testing (MTTT) Lyme testing.