(391 days)
BioWhitttaker's EBNA STAT test
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No
The device description details a standard ELISA assay, which is a biochemical method for detecting antibodies. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an In Vitro Diagnostic (IVD) used to aid in the diagnosis of infectious mononucleosis by detecting antibodies, not to treat or alleviate a disease.
Yes
The "Intended Use" section explicitly states that the assay "may be used in conjunction with other Epstein-Barr serologies... as an aid in the diagnosis of infectious mononucleosis." This clearly indicates its purpose in assisting with diagnosis.
No
The device description clearly outlines a physical ELISA kit with reagents, microtiter wells, and a photometric measurement step, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says "For In Vitro Diagnostic Use Only." This is a clear indication that the device is intended for use outside of a living organism to diagnose a condition.
- Device Description: The description details a laboratory test (ELISA) performed on a human specimen (serum) to detect antibodies. This is characteristic of an in vitro diagnostic test.
- Purpose: The intended use is "as an aid in the diagnosis of infectious mononucleosis," which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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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)
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Relative sensitivity and specificity: Three different sites compared the EBNA-1 IgG ELA test relative to a commercially available EIA assay. Two of the sites were R&D laboratories at commercial companies located in Maryland and New York. The other site was a large commercial lab located in Pennsylvania. The results of the studies are compiled and summarized in Table 1. None of the performance characteristics were established with specimens from patients having nasopharyngeal carcinoma or Burkitt's lymphoma.
Sample size: 350 (276 positive, 74 negative after excluding equivocals)
Relative Sensitivity = 270/276 = 97.8% (95% Confidence interval = 96.1% - 99.6%)
Relative Specificity = 74/74 = 100% (95% Confidence interval = 96.0% - 100%)
Relative Agreement = 344/350 = 98.3% (95% Confidence interval = 96.9% - 99.7%) -
Precision: Four different sera (High Positive, Mid Positive, Low Positive, and Negative) were assayed at three different sites to determine the precision of the assay. Each sera was tested three times each, twice a day for twenty days at each of the three study sites.
Sample size: n=360 total for inter-site precision.
High Positive: Mean 4.95, Std Dev 0.381, CV% 7.70%
Mid Positive: Mean 2.89, Std Dev 0.229, CV% 7.92%
Low Positive: Mean 1.41, Std Dev 0.152, CV% 10.78%
Negative: Mean 0.01, Std Dev 0.022, CV% not applicable
Calibrator (n=240): Mean 4.17, Std Dev 0.113, CV% 2.71%
High Positive Control (n=120): Mean 6.90, Std Dev 0.419, CV% 6.07% -
Linearity: The data illustrates EBNA-1 index values for serially two fold diluted sera. The index values are compared to log2 of dilution by standard linear regression. The data indicates that the antibody can be semi-quantitated by using a single serum dilution. Regression coefficients (slope, Y intercept, r) provided for 5 different sera.
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Cross-Reactivity: Tested sera containing IgG antibodies to Herpes Simplex Virus I & II, Cytomegalovirus, and Varicella Zoster Virus. The data indicates that antibodies to these Herpes Viruses do not cross-react with the EBNA-1 IgG EIA kit.
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Evaluation of paired sera: To validate the sensitivity of the paired sera procedure 20 high positive sera were serially two fold diluted and run on the assay. From these dilutions, there were 68 pairs that had a four fold dilution where the acute sera had a value of less than 3.70. All 68 pairs demonstrated a >46% rise in ISR value, showing a significant rise in antibody. Thus, the paired sera procedure demonstrated 100% sensitivity in being able to detect a four fold increase in antibody level when the acute sera has a value of
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).
0
APR 2 9 1996
Summary of Safety and Effectiveness Information EBNA-1 IgG EIA Test Kit
Immuno Probe Inc. I. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: March 28, 1995
II. Description of Device
The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
III. Predicate Device
The EBNA-1 IgG EIA test is substantially equivalent to BioWhitttaker's EBNA STAT test. Equivalence is demonstrated by the following comparative results:
1
Performance Characteristics
- Relative sensitivity and specificity. Three different sites compared the EBNA-1 IgG ELA test relative to a commercially available EIA assay. Two of the sites were R&D laboratories at commercial companies located in Maryland and New York. The other site was a large commercial lab located in Pennsylvania. The results of the studies are compiled and summarized in Table 1. None of the performance characteristics were established with specimens from patients having nasopharyngeal carcinoma or Burkitt's lymphoma.
Table 1 EBNA-1 IgG Relative Sensitivity and Specificity
+ eq = 270 5 + б Alternate EBNA-1 G 0 0 l eq ELISA -0 I 74
Total
281
1
હરે
357
ImmunoProbe EBNA-1 G EIA
| Relative Sensitivity = 270/276 = 97.8 | 95% Confidence interval = 96.1% - 99.6% |
|---|---|
| Relative Specificity = 74/74 = 100% | 95% Confidence interval = 96.0% - 100% |
| Relative Agreement = 344/350 = 98.3% | 95% Confidence interval = 96.9% - 99.7% |
6
8 I
270
Equivocals were not included in the above calculations.
Total
The 95% confidence interval for relative specificity was calculated assuming one false positive The 95% confidence intervals were calculated using the normal method.
2
- Precision. Four different sera (High Positive, Mid Positive, Low Positive, and Negative) were assayed at three different sites to determine the precision of the assay. Each sera was tested three times each, twice a day for twenty days at each of the three study sites. The inter-site coefficient of variation (CV) for each serum is presented in table i
Table 2 Inter Site Precision n= 360
| Mean | Std Dev | CV% | |
|---|---|---|---|
| High Positive | 4.95 | 0.381 | 7.70% |
| Mid Positive | 2.89 | 0.229 | 7.92% |
| Low Positive | 1.41 | 0.152 | 10.78% |
| Negative | 0.01 | 0.022 | not applicable |
| Calibrator (n=240) | 4.17 | 0.113 | 2.71% |
| High Positive Control (n=120) | 6.90 | 0.419 | 6.07% |
The data in table 3 illustrates EBNA-1 index values for serially two fold 3. Linearity. diluted sera. The index values are compared to log2 of dilution by standard linear The data indicates that the antibody can be semi-quantitated by using a single regression. serum dilution.
Table 3 EBNA-1 G Linearity
| Serum # | Neat | 1:2 | 1:4 | 1:8 | 1:16 | 1:32 | 1:64 | SLOPE | Y INTERCEPT | r |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 8.6 | 5.96 | 3.50 | 1.96 | 0.87 | 1.95 | -1.66 | 0.98 | ||
| 2 | 11.4 | 9.30 | 6.90 | 4.10 | 2.50 | 1.30 | 0.42 | 1.91 | -2.49 | 0.98 |
| 3 | 6.90 | 4.90 | 2.7 | 1.5 | 0.69 | 1.58 | -1.41 | 0.98 | ||
| 4 | 8.7 | 6.5 | 4.07 | 2.32 | 1.20 | 0.55 | 1.67 | -1.95 | 0.97 | |
| 5 | 9.4 | 7.17 | 4.8 | 3.2 | 1.5 | 0.70 | 1.77 | -1.75 | 0.98 |
Linear regression compared Index Values to log2 of dilution.
3
Serum containing IgG antibody detectable by ELISA to Herpes 4. Cross-Reactivity. Simplex Virus I & II, Cytomegalovirus, and Varicella Zoster Virus were assayed. The data summarized in Table 4 indicates that antibodies to these Herpes Viruses do not crossreact with the EBNA-1 IgG EIA kit.
TABLE 4
Cross Reactivity
| SERUM | EBNA-1 G | HSVI G | HSV2 G | CMV | VZV |
|---|---|---|---|---|---|
| 1 | 0.67 - | 2.43 + | 0.60 - | 1.69 + | 2.28 + |
| 2 | 0.36 - | 0.32 + | 0.08 - | 0.18 - | 3.17 + |
| 3 | 0.73 - | 3.67 + | 0.86 - | 1.11 + | 2.45 + |
| 4 | 0.29 - | 0.30 - | 0.39 - | 0.18 - | 3.21 + |
| 5 | 0.34 - | 6.18 + | 5.98 + | 0.18 - | 2.14 + |
Sera ≥ 1.10 were considered positive. Sera ≤ 0.90 were considered negative.
- Evaluation of paired sera. To validate the sensitivity of the paired sera procedure 20 high positive sera were serially two fold diluted and run on the assay. From these dilutions, there were 68 pairs that had a four fold dilution where the acute sera had a value of less than 3.70. All 68 pairs demonstrated a >46% rise in ISR value, showing a significant rise in antibody. Therefore the paired sera procedure demonstrated 100% sensitivity in being able to detect a four fold increase in antibody level when the acute sera has a value of