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

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

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

HBeAg Cassette

Serum/Plasma

ABT-IDT-B9

50T/25T

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®(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAg in serum or plasma.

TEST PROCEDURE

PERFORMANCE CHARACTERISTICS of

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.

Method

RIA

Total Results

ACCU-TELL®HBeAg Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

125

5

130

Negative

2

350

352

Total Results

127

355

482

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®(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 of

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



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