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Products

HBsAg Test
HBsAg Serum Test Cassette

Catalog No.        Product Name                 

ABT-IDT-B5            HBsAg  Serum  Cassette

 

INTENDED USE

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

Specificity

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

Method

ELISA

Total Results

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

Results

Positive

Negative

Positive

241

2

243

Negative

0

359

359

Total Results

241

361

602

Relative Sensitivity: >99.9% (95%CI*: 98.8%-100%)

Relative Specificity: 99.4% (95%CI*: 98%-100%)

Accuracy: 99.7% (95%CI*: 98.8%-100%)   *Confidence Intervals

 Precision

 Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens containing 0 ng/ml, 1 ng/ml and 5 ng/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 0 ng/ml, 1 ng/ml and 5 ng/ml of HBsAg in 15 independent assays. Three different lots of Accu-Tell® Rapid HBsAg 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 98% of the time.

Cross-reactivity

Accu-Tell® Rapid HBsAg 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® Rapid HBsAg 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.

 

LIMITATIONS

  1. Accu-Tell® Rapid HBsAg Test Cassette (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® Rapid HBsAg Test Cassette (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® Rapid HBsAg Test Cassette (Serum/Plasma) cannot detect less than 1 PEI 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.