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

Product Description

CATALOG

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^® 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.

TEST PROCEDURE

For Cassette:

For Strips:

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

For Cassette:

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

3. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μL) to the specimen well of test Cassette and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

3. Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

3. To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

4. Wait for the colored line(s) to appear. Read results at 15 ~30 minutes.  Do not interpret the result after 30 minutes.

For Strips:

1. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it within one hour.

2. Place the strip on a clean and level surface.

For Serum or Plasma specimen:

3. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μL) to the specimen area of test strip and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

3. Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen area, then add 1 drop of buffer (approximately 40 μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

3. To use a capillary tube: Fill the capillary tube and transfer approximately 50 μL of fingerstick whole blood specimen to the specimen area of test Strip, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

4. Wait for the colored line(s) to appear. Read results at 15~30 minutes.  Do not interpret the result after 30 minutes.

PERFORMANCE CHARACTERISTICS

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:

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:

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^® HBsAg Rapid Test Cassette/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. ACCU-TELL^® HBsAg Rapid Test Cassette/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^® HBsAg Rapid Test Cassette/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^® HBsAg Rapid Test Cassette/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.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.