Rapid Diagnostic HSV Test Kit Cassette Gold Colloidal Detect HSV 1/2 Antibodies

One Step HSV Rapid Diagnostic test, to detect antibodies to HSV 1/2 ,Gold colloidal,quickly and easily

Product Name:

One Step Herpes Simplex Virus Rapid Diagnostic test

One Step HSV Rapid Diagnostic test

Intended Use:

The Herpes Simplex Virus Rapid Test is a rapid qualitative lateral flow test designed for the quantitive detection of IgM antibodies to Herpes Simplex Virus (HSV) in human serum/plasma samples.

Summary:

HSV-1 is usually associated with infection in oropharyngeal area and eyes, while HSV-2 causes mostly genital and neonatal infections (5, 6), however, the tissue specificity is not absolute (7). HSV-2 can be isolated occasionally from the oropharynx and 5-10% of primary genital infections may be caused by HSV-1. Infants infected with HSV appear normal at birth, but almost invariably develop symptoms during the newborn period (5, 8, 9). Neonatal HSV infection may remain localized or become disseminated. Localized infection may involve one or a combination of sites. These are skin, eyes, mouth or the central nervous system. Disseminated infection is manifested by pneumonitis, hepatitis, disseminated intravascular coagulopathy and encephalitis. Of the infants with neonatal HSV, about one half of those surviving will develop severe neurological or ocular sequelae. A number of serological procedures have been developed to detect antibodies to HSV. These include complement fixation, indirect immunofluorescent antibody, plaque neutralization, and ELISA (6, 8, 10). Antibody of the IgM class is produced during the first 2-3 weeks of infection with HSV and exists only transiently in most patients. Serologic procedures, which measure the presence of IgM antibodies, help discriminate between primary and recurrent infections, since IgM antibodies is rarely found in recurrent infections. High affinity IgG antibodies to HSV, if present in a sample, may interfere with the detection of IgM specific antibody (9). High affinity IgG antibody may preferentially bind to HSV-1 antigen leading to false negative IgM results. Also, rheumatoid factor, if present, along with antigen specific IgG, may bind to IgG causing false positive IgM results. Both problems can be eliminated by deactivating IgG in the sample before testing for IgM.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready

to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid

cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERS:

Table: HSV Rapid Test vs. EIA Test

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.