INCSTAR HSV I/II IGG FAST ELISA ASSAY

K955362 · Incstar Corp. · IGC · Jul 24, 1996 · Pathology

Device Facts

• Record ID: K955362
• Device Name: INCSTAR HSV I/II IGG FAST ELISA ASSAY
• Applicant: Incstar Corp.
• Product Code: IGC · Pathology
• Decision Date: Jul 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.4010
• Device Class: Class 1

Intended Use

The INCSTAR Herpes Simplex Virus I/II IgG “fast” ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG “fast” ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.

Device Story

In vitro diagnostic ELISA kit; detects IgG antibodies to HSV-1 and HSV-2 in human serum. Principle: indirect ELISA using polystyrene microtiter wells coated with purified HSV-1 and HSV-2 antigens. Patient serum incubated with antigens; captured IgG detected via goat anti-human IgG (Fc) conjugated to horseradish peroxidase. Chromogen (tetramethylbenzidine) added; enzyme action produces color reaction measured by photometer at 450 nm. Enzyme activity proportional to specific anti-HSV IgG concentration. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing primary HSV infection and assessing immunological response.

Clinical Evidence

Clinical study of 305 serum samples from healthy individuals, transplant patients, and patients with various illnesses. Compared to reference ELISA kits. Results: relative sensitivity 94-99%, relative specificity 85-95%, overall agreement 90-100% (95% CI). Discrepant analysis via IFA showed 11/13 INCSTAR-positive/reference-negative samples were IFA-positive; 1/4 INCSTAR-negative/reference-positive samples was IFA-negative.

Technological Characteristics

Indirect ELISA; polystyrene microtiter wells coated with purified HSV-1 and HSV-2 antigens. Detection via goat anti-human IgG (Fc) conjugated to horseradish peroxidase. Chromogenic substrate: tetramethylbenzidine. Photometric detection at 450 nm. Manual or automated plate processing.

Indications for Use

Indicated for qualitative/semi-quantitative detection of IgG antibodies to HSV-1 and/or HSV-2 in human serum to determine immunological response to infection and aid in diagnosis of primary HSV infection. Population includes healthy individuals, transplant patients, and patients with various illnesses.

Regulatory Classification

Identification

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).

Predicate Devices

• Herpes 1 IgG Clin-ELISA (K852782)
• Herpes 2 IgG Clin-ELISA (K852781)

Reference Devices

• commercial HSV IgG IFA

Submission Summary (Full Text)

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K955362

JUL 24 1996

## I. SUMMARY OF SAFETY AND EFFECTIVENESS

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# I. SUMMARY OF SAFETY AND EFFECTIVENESS

**DEVICE NAME:** INCSTAR HSV I/II IgG “fast” ELISA Kit

**CLASSIFICATION:** Herpes simplex virus serological reagents
21 CFR 866.3305
Class III

**APPLICANT:** INCSTAR Corporation
1990 Industrial Boulevard
Stillwater, Minnesota 55082-0285

**INTENDED USE:**

The INCSTAR Herpes Simplex Virus I/II IgG “fast” ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG “fast” ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.

**DEVICE DESCRIPTION:**

The method for the determination of specific anti-HSV type 1 and/or type 2 IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified HSV type 1 and type 2 antigens. Diluted patient serum is incubated with the purified HSV antigens bound to the solid surface of the microtiter well. The HSV type 1 and/or type 2 IgG antibodies present in a patient’s serum will be captured by the solid phase. After washing, affinity purified polyclonal goat anti-human IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a wavelength of 450 nm. The measured enzyme activity is

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# I. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

directly proportional to the concentration of specific anti-HSV IgG bound to the solid phase.

## SAFETY AND EFFECTIVENESS:

The INCSTAR HSV I/II IgG “fast” ELISA Kit is substantially equivalent (SE) to the Herpes 1 IgG Clin-ELISA kit, 510(k) No. K852782 in combination with the Herpes 2 IgG Clin-ELISA kit, 510(k) No. K852781 which have been cleared by the FDA and are currently in U.S. commercial distribution.

In clinical performance studies, 305 serum samples represented by 305 individuals were tested with the INCSTAR HSV I/II IgG “fast” ELISA Kit and results were compared to those results generated from the Herpes 1 IgG Clin-ELISA and Herpes 2 IgG Clin-ELISA kits. The samples utilized represent a mixed population of healthy individuals, transplant patients, and patients with various illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 94% to 99%, a relative specificity of 85% to 95%, and an overall agreement of 90% to 100%.

Further resolution of discrepant results by a commercial HSV IgG IFA demonstrated that of the 13 samples positive by the INCSTAR HSV I/II IgG “fast” assay but negative by the reference ELISA assays, 11 were positive by IFA. Of the 4 samples negative by the INCSTAR HSV I/II IgG “fast” assay but positive by the reference ELISA assays, 1 was negative by IFA.

Prevalence, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR HSV I/II IgG “fast” ELISA Kit package insert. (See Section VII.A.1. Package Insert).