.

17.Accu-Tell® HBcAb Rapid Test Cassette (Serum/Plasma)

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

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

HBcAb Cassette

Serum/Plasma

ABT-IDT-B10

50T;25T

KEY POINTS

Detection for:Hepatitis B Core Antibody (HBcAb) in serum or plasma;

Specimen volume:75 μL;

Reading time:15 minutes;

Relative Sensitivity:96.9% (95%CI*: 94.4%-98.5%)

Relative Specificity:96.8% (95%CI*: 92.6%-98.9%)

Accuracy:97.0% (95%CI*: 95.0%-98.3%)

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 core antibody 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. If this test is negative, but a person is known to be HBcAb positive, then it indicates low levels of virus in the blood or an "integrated phase" of HBV in which the virus is integrated into the host’s DNA.

INTENDED USE

ACCU-TELL®(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Core Antibody (HBcAb) in serum or plasma.

TEST PROCEDURE

Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30℃) prior to testing.

PERFORMANCE CHARACTERISTICSof

Sensitivity and Specificity

ACCU-TELL®HBcAb Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HBcAb test, the result show that ACCU-TELL®HBcAb Cassette (Serum/Plasma) has a high sensitivity and specificity.

Method

ELISA

Total Results

ACCU-TELL®HBcAb Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

327

5

332

Negative

10

150

160

Total Results

337

155

492

Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)

Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)

Accuracy: 97.0% (95%CI*: 95.0%-98.3%)

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive and high positive. 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 and high positive of HBcAb in 15 independent assays. Three different lots of ACCU-TELL® HBcAb 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®HBcAb 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®HBcAb 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 and

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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