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Products

HBsAg Test
HBsAg Serum Test Strip

Catalog No.       Product Name

ABT-IDT-A5           One Step HBsAg Serum Test Strip

 

INTENDED USE

ACCU-TELL® One Step HBsAg Test Strip(Serum/Plasma)is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in serum or plasma.

PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL® One Step HBsAg Test Strip(Serum/Plasma) has been tested with a sensitivity panel ranging from 0 to 300ng/ml. All 10 HBsAg subtypes produced positive results on ACCU-TELL® One Step HBsAg Test Strip(Serum/Plasma). The test can detect 1 PEI ng/ml of HBsAg in serum/plasma

Specificity

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

 

Method

EIA

Total Results

ACCU-TELL® One Step HBsAg Test Strip(Serum/

Plasma)

Results

Positive

Negative

Positive

205

3

208

Negative

0

310

310

Total Results

205

313

518

Relative Sensitivity: >99.9% (97.5%CI*: 98.2%-100%)

Relative Specificity: 99.0% (95%CI*: 97.2%-99.8%)

Accuracy: 99.4% (95%CI*: 98.3%-99.9%)                              *Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens containing 0ng/ml, 1ng/ml and 5ng/ml of HBsAg. The negative and positive values were correctly identified 98% of the time.

Inter-Assay

Between-run precision has been determined by using the same three specimens of 0ng/ml, 1ng/ml and 5ng/ml of HBsAg in 15 independent assays. Three different lots of ACCU-TELL® One Step HBsAg Test Strip(Serum/Plasma) has been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 98% of the time.

Cross-reactivity

ACCU-TELL® One Step HBsAg Test 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® One Step HBsAg Test 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

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

  2. ACCU-TELL® One Step HBsAg Test Strip(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.

  4. ACCU-TELL® One Step HBsAg Test Strip(Serum/Plasma) cannot detect less than 1ng/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.