(91 days)
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No
The device description and performance studies detail a standard ELISA assay and statistical analysis of the results, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is an in vitro diagnostic test kit designed to detect antibodies to B. burgdorferi in human serum, which is used for diagnosis, not for treating or preventing disease.
Yes
The device is intended as a qualitative presumptive test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients of infection, which directly supports the diagnosis of Lyme disease.
No
The device is a laboratory test kit that includes physical reagents, controls, and strips, requiring a microplate reader for analysis. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of IgM antibodies to B. burgdorferi sensu stricto in human serum". This indicates it's used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test kit that uses reagents to analyze human serum samples for the presence of specific antibodies. This is a hallmark of in vitro diagnostic devices.
- Performance Studies: The document includes detailed descriptions of nonclinical and clinical studies conducted to evaluate the performance of the device using human samples. This is a requirement for IVDs to demonstrate their accuracy and reliability.
- Key Metrics: The inclusion of metrics like sensitivity, specificity, and percent agreement, derived from testing human samples, further confirms its nature as an IVD used for diagnostic evaluation.
- Predicate Device: The mention of a predicate device (K894224; Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit) which is also an ELISA test kit for detecting Borrelia burgdorferi antibodies, strongly suggests that the subject device falls under the same regulatory category as an IVD.
The entire context of the provided information points to a device designed and intended for use in a laboratory setting to perform diagnostic testing on human specimens outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gold Standard Diagnostics Borrelia burgdorfer igG ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay.
Product codes (comma separated list FDA assigned to the subject device)
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 antibodies conjugated with horseradish peroxidase is then added, which binds to the antigenantibody 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 450mm. The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgG 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 protein 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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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
Description of the training set (for cutoff determination):
- 210 normal sera (105 from an endemic region of Lyme disease, 105 from a non-endemic region of Lyme disease).
- An additional 194 samples consisting of 114 samples from different phases of Lyme disease, 8 negative healthy samples, 72 negative Lyme disease samples but with other diseases that may cause serologic cross-reactivity.
Annotation protocol: 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. A receiver operating characteristics (ROC) analysis was performed to evaluate the performance of the assay and confirm that the chosen cutoff provided the best compromise between sensitivity and specificity.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Studies:
- Determination of the Assay Cutoff:
- Sample size: 210 normal sera (105 endemic, 105 non-endemic), plus 194 additional samples (114 Lyme disease, 8 negative healthy, 72 negative Lyme with other diseases).
- Method: Mean plus two standard deviations used for cutoff. ROC analysis performed to confirm cutoff performance.
- Precision:
- Study type: Within-lab precision study.
- Sample size: 48 replicates for each of 4 panel members (negative, high negative, low positive, moderate positive) and 3 controls (positive, cutoff, negative).
- Method: Panel tested in duplicate, twice per day, for 12 days.
- Key results: CVs for Moderate Positive (7.1%), Low Positive (7.1%), High Negative (10.4%), Negative (14.8%), Positive Control (5.4%), Cutoff Control (2.6%), Negative Control (12.7%).
- Reproducibility:
- Study type: Reproducibility study at three different sites.
- Sample size: 90 replicates for each of 4 panel members (negative, high negative, low positive, moderate positive) and 3 controls (positive, cutoff, negative).
- Method: Panel tested in triplicate, twice per day, for five days.
- Key results: Total CVs for Moderate Positive (6.1%), Low Positive (9.3%), High Negative (10.2%), Negative (18.3%), Positive Control (3.2%), Cutoff Control (2.2%), Negative Control (9.6%).
- Analytical Specificity:
- Sample size: 208 asymptomatic individuals' samples (103 from endemic, 105 from non-endemic regions).
- Key results: Analytical Specificity: Endemic Region 96.1% (4/103 positive/equivocal), Non-endemic Region 100% (0/105 positive/equivocal).
- Cross Reactivity:
- Sample size: 377 samples from various infections and disease conditions.
- Key results: Varying cross-reactivity rates for Rickettsiosis IgG (24%), Ehrlichiosis IgG (20%), Epstein-Barr Virus IgG (3%), Varicella Zoster Virus (6%). Others showed 0% cross-reactivity.
- Interfering Substances:
- Study type: Evaluation of potential interfering substances.
- Sample size: Three samples (high negative, equivocal, low positive) spiked with interferents.
- Method: Tested along with unspiked serum. Concentrations based on EP07-A3 from CLSI.
- Key results: No effect detected for Albumin, Bilirubin, Cholesterol, Hemoglobin, Triglycerides.
Clinical Studies:
- Comparison with Predicate Device:
- Study type: Comparison study at three sites (one internal, two external).
- Sample size: 523 serum samples.
- Method: Samples tested on both subject device and predicate device.
- Key results:
- Positive percent agreement = 90.2% (55/61) (95% CI: 79.8% - 96.3%)
- Negative percent agreement = 99.6% (460/462) (95% CI: 98.5% - 99.9%)
- Second Tier Testing:
- Samples: All positive and equivocal samples from both devices (57 for subject, 61 for predicate, 55 for both).
- Method: Tested by an FDA cleared IgG Western blot assay.
- Key results: 2nd Tier PPA = 100% (37/37) (95% CI: 92.2% - 100%).
- Clinical Sensitivity:
- Study type: Sensitivity study.
- Sample size: 114 clinically characterized samples (early, disseminated, late stages of Lyme disease).
- Method: Tested on both subject device and predicate device.
- Key results:
- Early: Subject 46.6% (27/58), Predicate 27.6% (16/58)
- Disseminated: Subject 82.4% (14/17), Predicate 52.9% (9/17)
- Late: Subject 97.4% (38/39), Predicate 97.4% (38/39)
- CDC Panel:
- Study type: Evaluation with CDC masked characterized serum panel.
- Sample size: 280 positive and negative specimens.
- Key results (Agreement with Clinical Diagnosis):
- Healthy: Subject 99.0% (1 positive/equivocal), Predicate 99.0% (1 positive/equivocal)
- Early Lyme: Subject 68.3% (41 positive/equivocal), Predicate 35.0% (21 positive/equivocal)
- Cardiac Lyme: Subject 66.7% (2 positive/equivocal), Predicate 100% (3 positive/equivocal)
- Neurological Lyme: Subject 85.7% (6 positive/equivocal), Predicate 42.9% (3 positive/equivocal)
- Late: Subject 100% (20 positive/equivocal), Predicate 100% (20 positive/equivocal)
- Look-alike Disease: Subject 87.8% (11 positive/equivocal), Predicate 88.9% (10 positive/equivocal)
- Expected Values:
- Study type: Range of values and positivity rate among different studies and populations.
- Samples: Normal Endemic (103), Normal Non-Endemic (105), Prospective Study (523), Sensitivity Study (114).
- Key results:
- Normal Endemic: 3.9% Positive/Equivocal
- Normal Non-Endemic: 0.0% Positive/Equivocal
- Prospective Study: 10.9% Positive/Equivocal
- Sensitivity Study: 71.1% Positive/Equivocal
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Analytical Specificity: 96.1% (Endemic Region), 100% (Non-endemic Region)
- Positive Percent Agreement (with predicate): 90.2% (95% CI: 79.8% - 96.3%)
- Negative Percent Agreement (with predicate): 99.6% (95% CI: 98.5% - 99.9%)
- 2nd Tier Percent Agreement (PPA): 100% (95% CI: 92.2% - 100%)
- Clinical Sensitivity:
- Early Lyme: 46.6% (subject device)
- Disseminated Lyme: 82.4% (subject device)
- Late Lyme: 97.4% (subject device)
- % Agreement with Clinical Diagnosis (CDC Panel):
- Healthy: 99.0%
- Early Lyme: 68.3%
- Cardiac Lyme: 66.7%
- Neurological Lyme: 85.7%
- Late: 100%
- Look-alike Disease: 87.8%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test kit (K894224)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3830
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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April 21, 2020
Gold Standard Diagnostics Napoleon Monce Director, Product Development 2851 Spafford St. Davis, California 95618
Re: K200025
Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: December 27, 2019 Received: January 6, 2020
Dear Napoleon Monce:
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/ofdocs/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 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
1
- 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 (QS) 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,
Steven R. Gitterman -S
Steven Gitterman, M.D. Ph.D. Deputy Director 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) K200025
Device Name
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Indications for Use (Describe)
The Gold Standard Diagnostics Borrelia burgdorfer igG ELISA Test Kit is intended as a qualitative presumptive (first-step) test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay.
| 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
Image /page/3/Picture/0 description: The image shows the logo for Gold Standard Diagnostics. The logo features the words "GOLD STANDARD" in large, bold, black letters. To the left of the words is a gold circle with the letters "GSD" inside. Below the words "GOLD STANDARD" is the word "DIAGNOSTICS" in smaller, black letters.
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: 2851 Spafford St. Davis, CA. 95618 Phone Number: 530-759-8000 Contact Person: Napoleon Monce Date: December 27, 2019
-
- Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Common Name: Lyme ELISA Test
Regulation Section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents.
Classification: Class II
Product Code: LSR; Reagent, Borrelia Serological Reagent
-
- Legally Marketed Device to Which the Submitter Claims Equivalence: Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit (K894224).
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 complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG antibodies conjugated with horseradish peroxidase is then added, which binds to the antigenantibody 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 450mm.
4
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgG 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 protein 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.
5) Intended Use of the Device:
The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test kit is intended as a qualitative presumptive (first step) test for the detection of IgG 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.
6) Comparison with the Predicate Device:
The tables below provide a comparison of the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test kit with the Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test kit (predicate device: K894224).
| Similarities | ||
|---|---|---|
| Item | Subject Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi | ||
| IgG ELISA Test Kit | Predicate Device: Trinity Biotech | |
| MarDx Borrelia burgdorferi EIA IgG | ||
| Test Kit | ||
| Intended Use | The Gold Standard Diagnostics | |
| Borrelia burgdorferi IgG ELISA | ||
| Test kit is intended as a qualitative | ||
| presumptive (first step) test for the | ||
| detection of IgG 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 MarDx Borrelia | |
| burgdorferi EIA IgG Test System is a | ||
| qualitative test intended for use in the | ||
| presumptive detection of human IgG | ||
| antibodies to Borrelia burgdorferi in | ||
| human serum. This EIA system should | ||
| be used to test serum from patients with | ||
| a history and symptoms of infection with | ||
| B. burgdorferi. All positive and | ||
| equivocal specimens should be retested | ||
| with a highly specific, second-tier test | ||
| such as Western blot. Positive second- | ||
| tier results are supportive evidence of | ||
| infection with B. burgdorferi. The | ||
| diagnosis of Lyme disease should be | ||
| made based on history and symptoms | ||
| (such as erythema migrans), and other | ||
| laboratory data, in addition to the | ||
| presence of antibodies to B. burgdorferi. | ||
| Negative results (either first or second- | ||
| tier) should not be used to exclude Lyme | ||
| disease. | ||
| Assay Format | Antigen coated microtiter plate – | |
| 96 wells. | Same | |
| Technology | ELISA | Same |
5
| Sample Matrix | Human serum | Same |
|---|---|---|
| Sample Processing | Dilute Samples 1:100 in Diluent | Same |
| Controls Provided | Positive, Cutoff, Negative | Same |
| Reagents Provided | Diluent, Wash, Conjugate, | Same |
| Reagents Provided | Substrate, Stop Solution | Same |
| Reported Results | Positive, Equivocal, Negative | Same |
| Assay Output | Optical density readings from | Same |
| Assay Output | Spectrophotometer | Same |
| Differences | ||
|---|---|---|
| Item | Subject Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi | ||
| IgG ELISA Test Kit | Predicate Device: Trinity Biotech | |
| MarDx Borrelia burgdorferi EIA | ||
| IgG Test Kit | ||
| Volumes | 100ul sample, 50ul substrate, 50ul stop solution | 100ul sample, 100ul substrate, 100ul stop solution |
| Incubation | 15/15/15 minutes at room | |
| temperature | 30/30/10 minutes at room | |
| temperature | ||
| Antigens | B. burgdorferi B31 strain, | |
| B. burgdorferi 2591 strain, | ||
| B. burgdorferi recombinant VlsE strain | B. burgdorferi B31 strain | |
| Results Interpretation | Convert to units. | |
| Negative 11.0 | Convert to units. | |
| Negative H. pylori IgG | 11 | 0 / (0%) |
| Parvovirus B19 IgG | 12 | 0 / (0%) |
| Influenza A&B IgG | 12 | 0 / (0%) |
| Epstein-Barr Virus IgG | 34 | 1 / (3%) |
| Cytomegalovirus IgG | 31 | 0 / (0%) |
| Herpes Simplex Virus IgG | 21 | 0 / (0%) |
| Varicella Zoster Virus | 16 | 1 / (6%) |
| Fibromyalgia | 32 | 0 / (0%) |
| Rheumatoid Arthritis | 12 | 0 / (0%) |
| Autoimmune Disease | 59 | 0 / (0%) |
| Multiple Sclerosis | 23 | 0 / (0%) |
| Severe Periodontitis | 23 | 0 / (0%) |
Interfering Substances
The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test was evaluated. Three samples, a high negative, an equivocal and a low positive were spiked with high levels of interferants and were tested along
8
with serum without spiked interferants. The recommended concentrations from the guideline "Interference Testing in Clinical Chemistry" EP07-A3 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 ELISA Test.
| Substance | Concentration | Interference |
|---|---|---|
| Albumin | 60 mg/ml | None detected |
| Bilirubin | 0.4 mg/ml | None detected |
| Cholesterol | 4.0 mg/ml | None detected |
| Hemoglobin | 10 mg/ml | None detected |
| Triglycerides | 15 mg/ml | 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 twenty three (523) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and on the predicate B. burgdorferi IgG ELISA Test. The results are summarized in the following table:
| Predicate IgG ELISA | |||||
|---|---|---|---|---|---|
| Positive | Equivocal* | Negative | Total | ||
| Gold Standard Diagnostics | |||||
| Borrelia burgdorferi IgG | |||||
| ELISA Test Kit | Positive | 40 | 5 | 2 | 47 |
| Equivocal* | 3 | 7 | 0 | 10 | |
| Negative | 2 | 4 | 460 | 466 | |
| Total | 45 | 16 | 462 | 523 |
*Equivocal samples counted as positive
| Positive percent agreement = 90.2% (55/61) | 95% CI (79.8% - 96.3%) |
|---|---|
| Negative percent agreement = 99.6% (460/462) | 95% CI (98.5% - 99.9%) |
Second Tier Testing: All positive and equivocal samples by the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and by the Predicate IgG ELISA were tested by an FDA cleared IgG Western blot assay. The results are summarized in the following table:
| | Tier 1 Positive
or Equivocal | IgG Blot
Positive | IgG Blot
Negative |
|----------------------------------------------------------------------------|---------------------------------|----------------------|----------------------|
| Predicate IgG ELISA | 61 | 37 | 24 |
| Gold Standard
Diagnostics Borrelia
burgdorferi IgG
ELISA Test Kit | 57 | 37 | 20 |
9
| Predicate IgG ELISA
+
Gold Standard Diagnostics Borrelia
burgdorferi IgG
| ELISA Test Kit | 55 | 37 | 18 |
|---|---|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ---- | ---- | ---- |
| 2nd Tier Percent Agreement | ||
|---|---|---|
| 2nd Tier PPA | ||
| (95% CI) | 100% | |
| (92.2% - 100%) | 37/37 |
Clinical Sensitivity
Sensitivity Study
A sensitivity study was performed on 114 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 ELISA Test and on the predicate B. burgdorferi IgG ELISA Test. The results are summarized in the following table:
| Disease
Stage | n | Gold Standard
Diagnostics Borrelia
burgdorferi IgG ELISA
Test Kit | Predicate
IgG ELISA |
|------------------|----|----------------------------------------------------------------------------|------------------------|
| Early | 58 | 46.6% (27/58) | 27.6% (16/58) |
| Disseminated | 17 | 82.4% (14/17) | 52.9% (9/17) |
| Late | 39 | 97.4% (38/39) | 97.4% (38/39) |
CDC Panel
A panel of 280 positive and negative specimens from the Center of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and on the predicate device. The results are presented as a means to convey further information on the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test with a masked characterized serum panel. This does not imply an endorsement of the assay by the CDC. The results are summarized in the following table:
| Disease Stage | n | Gold Standard Diagnostics
Borrelia burgdorferi IgG
ELISA Test Kit | | Predicate
IgG ELISA | |
|---------------|-----|--------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 100 | 1 | 99.0% | 1 | 99.0% |
| Early Lyme | 60 | 41 | 68.3% | 21 | 35.0% |
10
| Cardiac Lyme | 3 | 2 | 66.7% | 3 | 100% |
|---|---|---|---|---|---|
| Neurological Lyme | 7 | 6 | 85.7% | 3 | 42.9% |
| Late | 20 | 20 | 100% | 20 | 100% |
| Look-alike | |||||
| Disease | 90 | 11 | 87.8% | 10 | 88.9% |
Expected Values
The range of values and positivity rate among different studies and population for the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test are as follows:
| Population | # Samples | Unit Results | Qualitative Results | |||
|---|---|---|---|---|---|---|
| Mean | Range | Std. | ||||
| Dev. | # | |||||
| Positive/ | ||||||
| Equivocal | % | |||||
| Positive/ | ||||||
| Equivocal | ||||||
| Normal | ||||||
| Endemic | 103 | 3.7 | 0.5 – 14.3 | 2.452 | 4 | 3.9% |
| Normal | ||||||
| Non-Endemic | 105 | 3.9 | 0.6 – 8.9 | 2.002 | 0 | 0.0% |
| Prospective | ||||||
| Study | 523 | 4.3 | 0.1 – 22.2 | 4.409 | 57 | 10.9% |
| Sensitivity | ||||||
| Study | 114 | 13.6 | 0.9 – 40.4 | 7.994 | 81 | 71.1 % |
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 ELISA Test is substantially equivalent to the Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test kit (predicate device: K894224).