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

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

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

HBeAb Cassette

Serum/Plasma

ABT-IDT-B8

50T/25T

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

INTRODUCTIONof

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

PERFORMANCE CHARACTERISTICSof

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.

Method

EIA

Total Results

ACCU-TELL®HBeAb Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

118

8

126

Negative

5

318

323

Total Results

123

326

449

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.We are also .

LIMITATIONS

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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