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Products

HBsAb Test
HBsAb Whole Blood Test Cassette

Catalog No.       Product Name

ABT-IDT-B79          Rapid HBsAb Whole Blood Test Cassette

 

INTENDED USE

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

PERFORMANCE CHARACTERISTICS

Sensitivity

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

 

Method

 

 

RIA

Total Results

ACCU-TELL®Rapid Test

 

Results

Positive

 

Negative

 

Cassette (Whole Blood

 

Positive

249

 

2

251

Serum/Plasma)

 

Negative

0

 

164

164

Total Results

 

249

 

166

415

Relative Sensitivity: >99.9% (95.0%CI*: 98.8%-100%)

Relative Specificity: 98.8% (95%CI*: 95.7%-99.9%)

Accuracy: 99.5% (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 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® Rapid HBsAb Test Cassette (Whole Blood/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® Rapid HBsAb Test Cassette (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 HBsAb Test Cassette (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, 1000mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.

 

LIMITATIONS

  1. ACCU-TELL® Rapid HBsAb Test Cassette (Whole Blood/ Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of HBsAb in serum or plasma specimen.

  2. ACCU-TELL® Rapid HBsAb Test Cassette (Whole Blood/ Serum/Plasma) cannot detect less than 10mIU/ml of HBsAb in specimens.

  3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.