Accu-Tell^® HBsAb Rapid Test Cassette/Strip (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

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

Specimen volume: 75 μL;

Reading time: 15 minutes;

Sensitivity: 10mIU/ml of HBsAb;

Relative Sensitivity: >99.9% (97.5%CI*: 98.7%-100%);

Relative Specificity: 98.4% (95%CI*: 95.3%-99.7%);

Accuracy: 99.3% (95%CI*: 97.9%-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. The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. The antibody to HBsAg, HBsAb, may not become detectable for 3-6 months after acute infection. It is associated with resolution of the illness. This antibody is recognized as the marker of immunity to HBV. As a result, vaccination against HBV was introduced to control the morbidity and mortality associated with the virus.

INTENDED USE

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

TEST PROCEDURE

For Cassette:

For Strip:

Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30℃) prior to testing.

For Cassette:

1. Remove the test cassette 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. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μL) to the specimen well of test device and start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.

3. Wait for the colored line is appeared. The result should be read at 15minutes. Do not interpret the result after 20 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 pointing toward the serum or plasma specimens, 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. See the illustration below.

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

Note: A low HBsAb 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 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity

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

Relative Sensitivity: >99.9% (97.5%CI*: 98.7%-100%)

Relative Specificity: 98.4% (95%CI*: 95.3%-99.7%)

Accuracy: 99.3% (95%CI*: 97.9%-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^® HBsAb Rapid Test Cassette/Strip (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^® HBsAb Rapid Test Cassette/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^® HBsAb Rapid Test Cassette/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^® HBsAb Rapid Test Cassette/Strip (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^® HBsAb Rapid Test Cassette/Strip (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.

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