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Accu-Tell® HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma)

ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood /Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in whole blood, serum or plasma.

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

HBsAg Strip

Whole Blood/Serum/Plasma

ABT-IDT-A6

100T/40T

HBsAg Cassette

Whole Blood/Serum/Plasma

ABT-IDT-B6

40T/20T

KEY POINTS

Detection for:Hepatitis B Surface Antigen in whole blood, serum or plasma

Specimen volume:Serum or Plasma specimen: 75 μL, or

Venipuncture Whole Blood specimen: 50 μL, or

Fingerstick Whole Blood specimen: 50 μL;

Reading time:15 ~30 minutes;

Sensitivity:1PEI ng/ml of HBsAg

Relative Sensitivity:>99.9% (95%CI: 98.5%-100%)

Relative Specificity:99.7% (95%CI: 99.0%-99.9%)

Accuracy:99.7% (95%CI: 99.2%-99.9%)

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. The complex antigen found on the surface of HBV is called HBsAg.

INTENDED USE

ACCU-TELL®Strip (Whole Blood /Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in whole blood, serum or plasma.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

For Cassette:

For Serum or Plasma specimen:

For Venipuncture Whole Blood specimen:

For Fingerstick Whole Blood specimen:

For :

For Serum or Plasma specimen:

For Venipuncture Whole Blood specimen:

For Fingerstick Whole Blood specimen:

PERFORMANCE CHARACTERISTICSof

Sensitivity

ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) was tested against a sensitivity panel including both ad and ay subtypes with concentrations ranging from 0 to 300ng/mL. The test can detect 1PEI ng/ml of HBsAg in whole blood, serum or plasma in 15 minutes.

Specificity

Antibodies used for ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) was also tested with laboratory strains of Hepatitis A and Hepatitis C. They all yielded negative results.

Serum or plasma specimens:

Method

EIA

Total Results

ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma)

Results

Positive

Negative

Positive

200

3

203

Negative

0

910

910

Total Results

200

913

1113

Relative Sensitivity: >99.9% (95%CI: 98.5%-100%)

Relative Specificity: 99.7% (95%CI: 99.0%-99.9%)

Accuracy: 99.7% (95%CI: 99.2%-99.9%)

Whole blood specimens:

Method

EIA

Total Results

ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma)

Results

Positive

Negative

Positive

100

1

101

Negative

0

139

139

Total Results

100

140

240

Relative Sensitivity: >99.9% (95%CI: 97.0%-100%)

Relative Specificity: 99.3% (95%CI: 96.1%-99.9%)

Accuracy: 99.6% (95%CI: 97.7%-99.9%)

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of six specimens containing 0ng/ml, 2ng/ml, 5ng/ml, 12ng/ml and 20ng/ml of HBsAg. The negative and positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by using the same six specimens of 0ng/ml, 2ng/ml, 5ng/ml, 12ng/ml and 20ng/ml of HBsAg in 3 independent assays. Three different lots of ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) have been tested using negative, low positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL®Strip (Whole Blood/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®HBsAg Rapid Test Cassette/Strip (Whole Blood/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 2,000mg/dl Hemoglobin,1000 mg/dl Bilirubin, and 2000 mg/dl human serum Albumin.

LIMITATIONS

  1. the presence of HBsAg in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis B viral infection.
  2. We are

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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