SERAQUEST HSV IGG

K963282 · Quest Intl., Inc. · LGC · Jan 22, 1997 · Microbiology

Device Facts

• Record ID: K963282
• Device Name: SERAQUEST HSV IGG
• Applicant: Quest Intl., Inc.
• Product Code: LGC · Microbiology
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Indications for Use

For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus. For manual use, or for use with the HyPrep System Plus. These reagents have not received FDA clearance for use in testing blood or plasma donors.

Device Story

SeraQuest™ HSV IgG is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against HSV-1 or HSV-2 in human serum. Input: human serum samples. Process: samples incubated in microwells coated with HSV-1 and HSV-2 antigens; captured IgG antibodies bind to enzyme-labeled anti-human IgG conjugate; substrate added to produce yellow end-product proportional to antibody concentration. Output: photometric absorbance read at 405 nm, normalized to Index values. Used in clinical laboratories; performed manually or via HyPrep System Plus. Results aid clinicians in assessing patient immunological response to HSV. Benefits include standardized serological assessment of HSV infection status.

Clinical Evidence

Bench testing only. Evaluated using CDC HSV/CMV serology panel (n=72), showing 95% total agreement (93% positive, 100% negative). Comparative study with 207 serum specimens against predicate device showed relative sensitivity of 99.5-100% and overall agreement ranging from 88.2% to 97.6% depending on the specific HSV type comparison.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA). Components: plastic microwell plates, HSV-1 (MacIntyre) and HSV-2 (MS) antigens, goat anti-human IgG (gamma chain specific) conjugated with alkaline phosphatase, p-Nitrophenyl phosphate substrate, 0.5 M Trisodium phosphate stop reagent. Readout: spectrophotometric at 405 nm. Manual or automated (HyPrep System Plus) processing.

Indications for Use

Indicated for qualitative and semi-quantitative detection of human IgG antibodies to HSV-1 or HSV-2 in human serum to aid in assessing immunological response. Population includes adults, including women of childbearing age (18-45 years). Not for use in blood or plasma donor screening.

Regulatory Classification

Identification

Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).

Predicate Devices

• HSV-1 and HSV-2 Clin-ELISA™ kits (INCSTAR Corporation)

Submission Summary (Full Text)

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APPENDIX 5.
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181
Page No. 256
JAN 22 1997
K963282

# 510(k) SUMMARY

| Applicant: | Quest International, Inc.
1938 N.E. 148th Terrace
North Miami, FL 33181 |
| --- | --- |
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, President |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest™ HSV IgG |
| Device Name: | Herpes Simplex Virus serological reagents (21CFR § 866.3305) |
| Device Classification: | Class III (premarket approval) |

## Description:

The SeraQuest™ HSV IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against type 1 or type 2 herpes simplex virus (HSV), in human serum.

The Calibrators in the SeraQuest HSV IgG test set have been assigned Index values based on an in-house standard. Test results are normalized and reported as Index values.

## Principle:

Diluted samples are incubated in wells coated with Type 1 and Type 2 herpes simplex virus. HSV antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically.

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APPENDIX 5.
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181
Page No. 257

# Intended Use:

For the qualitative and semi-quantitative detection of human IgG antibodies to herpes simplex virus (type 1 or type 2) in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to herpes simplex virus. For manual use, or for use with the HyPrep System Plus. These reagents have not received FDA clearance for use in testing blood or plasma donors.

# Predicate device:

The SeraQuest™ HSV IgG test is substantially equivalent in intended use and performance, to the HSV-1 and HSV-2 Clin-ELISA™ kits, INCSTAR Corporation, Stillwater Minnesota.

## Summary of technological characteristics:

| Characteristic | SeraQuest™ HSV IgG | INCSTAR Herpes Type 1 and Type 2 Clin-ELISA™ |
| --- | --- | --- |
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | Detection of IgG antibodies against type 1 HSV and type 2 HSV, in human serum. | Detection of IgG antibodies against type 1 HSV or type 2 HSV, in human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen Strain: | Type 1: MacIntyre
Type 2: MS | Type 1: MacIntyre
Type 2: MS |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:50 |
| Sample Incubation Duration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | | |
| Antibody | Goat anti-human IgG (gamma chain specific) | Goat or Sheep anti-human IgG (gamma chain specific) |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 μl | 200 μl |

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APPENDIX 5.
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181
Page No. 258

| Conjugate Incubation Duration: | 30 minutes | 30 minutes |
| --- | --- | --- |
| Substrate: | p-Nitrophenyl phosphate | p-Nitrophenyl phosphate |
| Substrate Volume: | 100 μl | 200 μl |
| Substrate Incubation Duration: | 30 minutes | 45 minutes |
| Stop Reagent: | 0.5 M Trisodium phosphate | 3 N Sodium Hydroxide |
| Stop Reagent Volume: | 100 μl | 50 μl |
| Readout: | Spectrophotometric 405 nm | Spectrophotometric 405 nm |

## Summary of Test Results Obtained with the Centers for Disease Control and Prevention HSV / CMV evaluation panel

The following information was obtained with the Centers for Disease Control and Prevention (CDC) serum panel for HSV / CMV serology assays, which was tested in-house by the SeraQuest™ HSV IgG test. The results are presented here as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement by the CDC.

The panel consists of 72 % positive and 28 % negative samples. The SeraQuest HSV IgG Test demonstrated 95 % total agreement with the CDC results. Of the results obtained by SeraQuest, there was 93 % agreement with the positive specimens, and 100 % agreement with the negative specimens.

## Comparison testing with the Predicate Device

Two hundred and seven serum specimens, which were randomly obtained in South Florida were assayed by the SeraQuest HSV IgG test and a predicate device which utilizes antigen wells coated with non-specific type 1, or type 2 HSV antigens. The results of these assays are shown below in Table 1.

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APPENDIX 5. Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181
Page No. 259

# TABLE 1.

RESULTS OF SeraQuest™ HSV IgG ASSAYS (USING THE REVISED CUT-OFF VALUES AS PER C.D.C.), AND ANOTHER COMMERCIALLY AVAILABLE HSV IgG ASSAY, OF 207 SERUM SPECIMENS. THE TEST SPECIMENS, WHICH INCLUDED 40 FROM WOMEN OF CHILD BEARING AGE (18 TO 45 YEARS), WERE COLLECTED IN SOUTH FLORIDA, AND TESTED AT QUEST INTERNATIONAL, INC., MIAMI, FL.

## SeraQuest HSV IgG

| INCSTAR HERPES IgG TYPE 1 | | | | | |
| --- | --- | --- | --- | --- | --- |
| | Positive | Equivocal | Negative | 95 % CI* | |
| Positive | 158 {36} | 0 | 0 | Relative sensitivity√ | 99.5 to 100 |
| Negative | 11 {2} | 8 | 30 {2} | Relative specificity√ | 59.6 to 86.7 |
| | | | | Overall agreement√ | 91.3 to 97.6 |
| INCSTAR HERPES IgG TYPE 2 | | | | | |
| | Positive | Equivocal | Negative | 95 % CI* | |
| Positive | 153 {35} | 0 | 0 | Relative sensitivity√ | 99.5 to 100 |
| Negative | 16 {3} | 8 | 30 {2} | Relative specificity√ | 51.5 to 79.0 |
| | | | | Overall agreement√ | 88.2 to 95.7 |
| INCSTAR HERPES IgG TYPE 1 & TYPE 2 | | | | | |
| | Positive | Equivocal | Negative | 95 % CI* | |
| Positive | 158 {36} | 0 | 0 | Relative sensitivity√ | 99.5 to 100 |
| Negative | 11 {2} | 8 | 30 {2} | Relative specificity√ | 59.6 to 86.7 |
| | | | | Overall agreement√ | 91.3 to 97.6 |

☑ Excluding equivocal results.
☐ Calculated by the normal method.
☐ Number of female donors of childbearing age.

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