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

Product Name:

One Step Herpes Simplex Virus IgG/IgM Combo Rapid Diagnostic test

One Step HSV IgG/IgM Combo Rapid Diagnostic test

Intended Use:

The HSV 1/2 IgG/IgM Combo Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma to aid in the diagnosis of HSV 1/2 infection.

Summary:

HSV 1/2 virus is a member of the Togaviridae family, found mainly in human populations. Generally rubella is considered a mild adolescence disease. However a maternal infection could be transmitted through the placenta to the fetus, causing congenital rubella. Primary rubella infection contracted during early pregnancy, may have severe consequences as severe fetal damage, stillbirth or abortion. Children born asymptomatic may develop these abnormalities later in life.1,2 Widespread vaccination has significantly reduced the incidence of rubella in all age groups. However, 10 to 20% of young adults still appear susceptible to the virus. To reduce risk of severe complications, accurate serological methods must be performed to determine the serologic status of childbearing aged women. The HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to rubella virus in whole blood, serum or plasma specimens.

TEST PRINCIPLE

The HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma specimens. In this test, HSV 1/2 Antigen is coated in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with mouse anti-human IgG or goat anti-human IgM coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the HSV 1/2 Antigen on the membrane in the test line region respectively. The presence of a colored line in the test line region indicates a positive result for HSV 1/2 infection, while its absence indicates a negative result for that infection.

To serve as a procedural control, a colored line will always appear in the respective control line regions of all the two strips indicating that proper volume of specimen has been added and membrane wicking has occurred.

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 cassette from the sealed pouch and use it within one hour. Best results will be obtained if the assay is performed as soon as possible.

3. Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen about 1cm above the upper end of the nozzle as shown in illustration below. Transfer 1 full drop (approx. 20μL) of specimen to each sample well, then add 2 drops of buffer (approximately 80μL) to each sample well and start the timer. See the illustration below.

4. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results 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:

Sensitivity and Specificity

The HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with leading commercial EIA HSV 1/2 tests; the results show that HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) has a high sensitivity and specificity.

Relative Sensitivity: 91.4% (95%CI*: 76.9%-98.2%) *Confidence Interval

Relative Specificity: 98.7% (95%CI*: 96.7%-99.6%)

Accuracy: 97.9% (95%CI*: 95.8%-99.2%)

Relative Sensitivity: 94.3% (95%CI*: 80.8%-99.3%) *Confidence Interval

Relative Specificity: 98.4% (95%CI*: 96.2%-99.5%)

Accuracy: 97.9% (95%CI*: 95.8%-99.2%)

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.