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Products

HBsAg Test
HBsAg Whole Blood Test Strip

Catalog No.       Product Name

ABT-IDT-A6           Rapid HBsAg Whole Blood Test Strip

 

INTENDED USE

ACCU-TELL® Rapid HBsAg Test 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.

PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL® Rapid HBsAg Test 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® Rapid HBsAg Test Strip (Whole/Blood/Serum/Plasma) were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of ACCU-TELL® Rapid HBsAg Test 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® Rapid HBsAg Test Strip (WholeBlood/

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® Rapid HBsAg Test 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® Rapid HBsAg Test 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® Rapid HBsAg Test 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® Rapid HBsAg Test 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. ACCU-TELL® Rapid HBsAg Test Strip(Whole Blood/Serum/Plasma) is for professional in vitro diagnostic use only. The test should be used for the detection of HBsAg in whole blood, serum or plasma specimen. Neither the quantitative value nor the rate of HBsAg concentration can be determined by this qualitative test.

  2. ACCU-TELL® Rapid HBsAg Test Strip(Whole Blood/Serum/Plasma) will only indicate the presence of HBsAg in the specimen and should not be used as the sole criteria for the diagnosis of Hepatitis B viral infection.

  3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician. ACCU-TELL® Rapid HBsAg Test Strip(Whole Blood/Serum/Plasma) cannot detect less than 1PEI ng/ml of HBsAg in specimens. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of Hepatitis B infection.