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Products

HSV 1/2 IgM Test Cassette
HSV 1/2 IgM SerumTest Cassette

Catalog No.      Product Name

ABT-FT-B212   Rapid HSV 1/2 IgM Serum/Plasma Test Cassette

INTENDED USE

ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to HSV 1/2 in serum or plasma to aid in the diagnosis of HSV 1/2 infection.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma) was compared with leading commercial EIA HSV 1/2 tests; the results show that ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma)has a high sensitivity and specificity.

Method

HSV 1/2 EIA (IgM)

Total Results

ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette

Results

Positive

Negative

Positive

20

1

21

Negative

2

305

307

Total Results

22

306

328

Sensitivity: 90.9% (95%CI*: 70.8%~98.9%)

Specificity: 99.7% (95%CI*: 98.2%~100%)

Accuracy: 99.1% (95%CI*: 97.4%~99.8%)

*Confidence Interval

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® Rapid HSV 1/2 IgM Test 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® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, RF, Syphilis, H. Pylori, Rubella, TOXO, CMV positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following compounds have been tested using ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma) and no interference was observed.

Acetaminophen: 20mg/dl          

 Caffeine: 20mg/dl            

 Hemoglobin: 1g/dl

 Oxalic acid: 60mg/dl                   

 Bilirubin: 1g/dL                  

 Uric acid: 20mg/ml

 Ascorbic Acid: 20mg/ml             

 Aspirin: 20mg/dl              

 Methanol: 10%

 Gentisic Acid: 20mg/dl               

 Creatine: 200mg/dl         

 Albumin: 2g/dl

LIMITATIONS

  1. ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of IgM antibodies to HSV-1 and/or HSV-2 in serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgM antibodies to HSV-1 and/or HSV-2 can be determined by this qualitative test.

  2. ACCU-TELL® Rapid HSV 1/2 IgM Test Cassette(Serum/Plasma) will only indicate the presence of IgM antibodies to HSV-1 and/or HSV-2 in the specimen and should not be used as the sole criteria for the diagnosis of HSV 1/2 infection.

  3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

  4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of HSV 1/2 infection.