Accu-Tell^® HSV-2 IgG/IgM Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgG and IgM antibodies to HSV-2 in serum or plasma;

Reading time: 15 minutes;

Sensitivity & Specificity & Accuracy:

IgG:

Sensitivity: 97.5% (95%CI: 86.8%~99.9%)*

Specificity: 99.0% (95%CI: 96.4%~99.9%)*

Accuracy: 98.8% ( 95%CI: 96.4%~99.7%)*

*Confidence Interval

IgM:

Sensitivity: ＞90.0%(95%CI:68.3%-98.8%)*

Specificity: 100.0% (95%CI: 98.5%~100%)*

Accuracy: 99.1% (95%CI: 96.8%~99.9%)*  

INTRODUCTION

Herpes Simplex Virus (HSV) is a common pathogen of humans. There are two distinct types of HSV: Types 1 and 2. HSV-1 is usually associated with infection in the oropharyngeal area and eyes while HSV-2 causes mostly genital and neonatal infections.

INTENDED USE

ACCU-TELL^® HSV-2 IgG/IgM Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV-2 in serum or plasma to aid in the diagnosis of HSV-2 infection.

TEST PROCEDURE

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour. Best results will be obtained if the assay is performed within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 1 drops of serum or plasma (Approx.25ul) and 2 drops of buffer to the specimen well of the test cassette. Avoid trapping air bubbles in the specimen well. See the illustration above.

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

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

A clinical evaluation was conducted comparing the results obtained using ACCU-TELL^® HSV-2 IgG/IgM Cassette (Serum/Plasma) to HSV-2 IgG/IgM ELISA Testing. The study included 240 IgG specimens and 220 IgM specimens, and about the IgG specimen both assays identified 199 negative and 41 positive results, about the IgM specimen both assays identified 202 negative and 18 positive results.

IgG Results

Sensitivity: 97.5% (95%CI: 86.8%~99.9%)*

Specificity:   99.0% (95%CI: 96.4%~99.9%)*

Accuracy: 98.8% ( 95%CI: 96.4%~99.7%)*

*Confidence Interval

IgM Results

Sensitivity: ＞90.0%(95%CI:68.3%-98.8%)*

Specificity:   100.0% (95%CI: 98.5%~100%)*   

Accuracy: 99.1% (95%CI: 96.8%~99.9%)*

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive, and a high positive. The negative, low positive, and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same three specimens: a negative, a low positive, and a high positive. Three different lots of ACCU-TELL® HSV-2 IgG/IgM Cassette (Serum/Plasma) have been tested over a 3-day period using negative, low positive, and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® HSV-2 IgG/IgM Cassette (Serum/Plasma) has been tested for HBsAg, HBsAb, HbeAg, HBeAb, HBcAb, HCV, HIV, Syphilis, H. Pylori, CMV and Rubella positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following compounds have also been tested using ACCU-TELL^® HSV-2 IgG/IgM Cassette (Serum/Plasma) and no interference was observed.

Ascorbic Acid:  20mg/ml        

Hemoglobin: 1000mg/dl         

Gentisic Acid: 20 mg/dL

Oxalic Acid: 60mg/dL           

Bilirubin: 1000mg/dL            

Uric acid: 20mg/ml

Acetaminophen:  20 mg/dL     

Aspirin: 20mg/dl                

Methanol: 10%

Creatine: 200mg/dl             

Albumin: 2 g/dL                

Caffeine: 20 mg/dl

LIMITATIONS

1. The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to HSV-2 in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

2. ACCU-TELL^® HSV-2 IgG/IgM Cassette (Serum/Plasma) is limited to the qualitative detection of the antibodies to HSV-2 in human serum or plasma. The intensity of the test band does not linear correlation with the antibody titer in the specimen.

3. A negative result for an individual subject indicates absence of detectable HSV-2 antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with HSV-2.

4. A negative result can occur if the quantity of the HSV-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected

5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.