Accu-Tell^® HSV 1/2 IgM Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgM antibodies to HSV 1/2 in serum or plasma；

Reading time: 15 minutes；

Relative Sensitivity: 90.9%；

Relative Specificity: 99.7%

Accuracy: 99.1%

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 gennital and neonatal infections.

INTENDED USE

ACCU-TELL^® HSV 1/2 IGM Rapid 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.

TEST PROCEDURE

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. 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 draw the serum/plasma up to the Fill Line as shown in illustration below (approximately 10 ul ) and 2 drops of buffer (approx. 80ul) 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 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

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^® HSV 1/2 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 1/2 IGM 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^® HSV 1/2 IGM 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^® HSV 1/2 IGM 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^® HSV 1/2 IGM 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.

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