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

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

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

HBsAb Strip

Serum/Plasma

ABT-IDT-A7

100T;50T

HBsAb Cassette

Serum/Plasma

ABT-IDT-B7

50T;25T

KEY POINTS

Detection for:Antibody to Hepatitis B Surface Antigen in serum or plasma;

Specimen volume:75 μL;

Reading time:15 minutes;

Sensitivity:10mIU/ml of HBsAb;

Relative Sensitivity:>99.9% (97.5%CI*: 98.7%-100%);

Relative Specificity:98.4% (95%CI*: 95.3%-99.7%);

Accuracy:99.3% (95%CI*: 97.9%-99.9%).

*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, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. The antibody to HBsAg, HBsAb, may not become detectable for 3-6 months after acute infection. It is associated with resolution of the illness. This antibody is recognized as the marker of immunity to HBV. As a result, vaccination against HBV was introduced to control the morbidity and mortality associated with the virus.

INTENDED USE

ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Antibody to Hepatitis B Surface Antigen in serum or plasma.

TEST PROCEDUREof

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

For Cassette:

For Strip:

Note: A low HBsAb concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 20 minutes.

We also produce and

PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) has been tested with a sensitivity panel ranging from 1mIU/ml to 40mIU/ml. The test can detect 10mIU/ml of HBsAb in 15 minutes.

Specificity

Antigen used for ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) is highly specific for detecting HBsAb in serum or plasma. The specificity was comparable to RIA.

Method

RIA

Total Results

ACCU-TELL®HBsAbRapid Test(Serum/Plasma)

Results

Positive

Negative

Positive

231

3

234

Negative

0

180

180

Total Results

231

183

414

Relative Sensitivity: >99.9% (97.5%CI*: 98.7%-100%)

Relative Specificity: 98.4% (95%CI*: 95.3%-99.7%)

Accuracy: 99.3% (95%CI*: 97.9%-99.9%)

*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 HBsAb in 15 independent assays. Three different lots of ACCU-TELL®HBsAb Rapid Test Cassette/Strip (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®HBsAb Rapid Test Cassette/Strip (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®/Strip (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

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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