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

Product Description

CATALOG

KEY POINTS

Detection for: HBeAb in serum or plasma;

Specimen volume: 75 μL;

Reading time: 15 minutes;

Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)

Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)

Accuracy: 97.1% (95%CI*: 95.1%-98.4%)

*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 (HAV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).   Hepatitis B e antibody is a protein secreted by HBV-infected cells. The presence of antibody against hepatitis B viral e antigen is used as an indicator for early HBs antigenemia before the peak of viral replication and early convalescence when HBeAg has declined below detectable levels. It is also useful to confirm a seroconversion.

INTENDED USE

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

TEST PROCEDURE

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

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

Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)

Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)

Accuracy: 97.1% (95%CI*: 95.1%-98.4%)

*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 HBeAb. 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 HBeAb in 15 independent assays. Three different lots of ACCU-TELL^® HBeAb 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^® HBeAb 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^® HBeAb 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^® HBeAb Rapid Test Cassette (Serum/Plasma) is for professional in vitro diagnostic use only. The test should be used for the detection of HBeAb in serum or plasma specimen. Neither the quantitative value nor the rate of HBeAb concentration can be determined by this qualitative test.

2.ACCU-TELL^® HBeAb Rapid Test Cassette (Serum/Plasma) will only indicate the presence of HBeAb 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.