ACCU-Tell^® HBsAg Rapid Test Cassette/Strip (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: Hepatitis B Surface Antigen in serum or plasma;

Specimen volume: 120 μL;

Reading time: 15~30 minutes;

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

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 (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in serum or plasma.

For professional in vitro diagnostic use only.

TEST PROCEDURE

For Cassette:

For Strip:

For Cassette:

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. For Serum or Plasma specimen:

Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 120 μL) to the specimen well of test device and start the timer. See illustration below.

3. Wait for the colored line is appeared. The result should be read at 15~30 minutes. Do not interpret the result after 30 minutes.

For Strip:

1. Remove the test strip from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. With arrows towards pointing toward serum or plasma specimen, immerse the test strip vertically in the serum or plasma for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See illustration below.

3. Place the strip on a non-absorbent flat surface, start the timer and wait for the color line (s) to appear. The result should be read at 15 minutes.

Note: A low HBsAg concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 30 minutes.

PERFORMANCE CHARACTERISTICS 

Sensitivity

ACCU-TELL^® HBsAg Rapid Test (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^® HBsAg Rapid Test (Serum/Plasma). The test can detect 1 PEI ng/ml of HBsAg in serum/plasma

Specificity

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

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

 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^® HBsAg Rapid Test (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^® HBsAg Rapid Test (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 (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, 1000mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.

LIMITATIONS

1. ACCU-TELL^® HBsAg Rapid Test (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^® HBsAg Rapid Test (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^® HBsAg Rapid Test (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.

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