Accu-Tell^® HBeAg Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: HBeAg in serum or plasma

Specimen volume: 75ul

Reading time: 15 minutes

Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%)

Relative Specificity: 98.6% (95%CI*: 96.7%-99.5%)

Accuracy: 98.5% (95%CI*: 97.0%-99.4%)

*Confidence Intervals

INTRODUCTION

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. Hepatitis B e antigen is a viral protein secreted by HBV-infected cells. Its presence indicates high levels of virus in the blood, and it is an indicator of the infectiousness of the carrier.

INTENDED USE

ACCU-TELL^® HBeAg Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAg in serum or plasma.

TEST PROCEDURE

1. Remove the test cassette from the sealed foil 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 clean and level surface. Hold the dropper vertically and transfer 3 full drops of serum or plasma (approx.75ul) to each sample well of the test cassette respectively, then start the timer. Avoid trapping air bubbles in the specimen well. See the illustration above.

3. Wait for the red line to appear. The result should be read at 15 minutes. Do not interpret the results after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

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

Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%)

Relative Specificity: 98.6% (95%CI*: 96.7%-99.5%)

Accuracy: 98.5% (95%CI*: 97.0%-99.4%)

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive, high positive of HBeAg. The negative and positive values were correctly identified 99% of the time.

Inter-Assay

Between-run precision has been determined by using the same three specimens of negative, low positive, high positive of HBeAg in 15 independent assays. Three different lots of ACCU-TELL^® HBeAg Rapid Test Cassette (Serum/Plasma) has been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 99% of the time.

Cross-reactivity

ACCU-TELL^® HBeAg Rapid Test Cassette (Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity

Interfering Substances

ACCU-TELL^® HBeAg Rapid Test Cassette (Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens. No interference was observed.

In addition, no interference was observed in specimens containing up to 2,000 mg/dL Hemoglobin, 1000 mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.

LIMITATIONS

1. ACCU-TELL^® HBeAg Rapid Test Cassette (Serum/Plasma) is for professional in vitro diagnostic use only. The test should be used for the detection of HBeAg in serum or plasma specimen. Neither the quantitative value nor the rate of HBeAg concentration can be determined by this qualitative test.

2. ACCU-TELL^® HBeAg Rapid Test Cassette (Serum/Plasma) will only indicate the presence of HBeAg in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis B viral infection.

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

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