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

Product Description

CATALOG

KEY POINTS

Detection for: Hepatitis B Surface Antigen (HBsAg), Hepatitis B Surface Antibody (HBsAb), Hepatitis B Envelope Antigen (HBeAg), Hepatitis B Envelope Antibody (HBeAb), and Hepatitis Core Antibody (HBcAb)  in serum or plasma.

Specimen volume: Serum or Plasma Specimen: 75μl

Reading time: 15 minutes

HBsAg:

Relative Sensitivity: >99.9% (97.5%CI*: 97.2%-100%)

Relative Specificity: 99.3% (95%CI*: 97.6%-99.9%)

Accuracy: 99.5% (95%CI*: 98.3%-99.9%)

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%)

HBeAg:

Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%)

Relative Specificity: 98.6% (95%CI*: 96.7%-99.5%)

Accuracy: 98.5% (95%CI*: 97.0%-99.4%)   

HBeAb:

Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)

Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)

Accuracy: 97.1% (95%CI*: 95.1%-98.4%)     

HBcAb:

Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)

Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)

Accuracy: 97.0% (95%CI*: 95.0%-98.3%)    

INTRODUCTION

Chronic hepatitis B is a serious, debilitating illness that can cause cirrhosis of the liver, liver cancer and death. Chronic hepatitis B is the main cause of liver cancer and the tenth leading cause of death worldwide, with 400,000,000 people infected with the virus. Every year, one million people worldwide are expected to die from this infection.

INTENDED USE

ACCU-TELL^® HBV Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.

TEST PROCEDURE

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 within one hour.

2. Place the test cassette on clean and level surface. Hold the dropper vertically and transfer 3 full drops of serum or plasma (approx.75μl) to each sample well of the test cassette respectively, then start the timer. Avoid trapping air bubbles in the specimen well. See the illustration .

3. Wait for the red line to appear. The result should be read at 15 minutes. Do not interpret the results after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL^® HBV Rapid Test Cassette (Serum/Plasma) was compared with leading commercial EIA/RIA HBsAg, HBsAb, HBeAg, HBeAb, HBcAb tests, the results show that ACCU-TELL^® HBV Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

HBsAg

Relative Sensitivity: >99.9% (97.5%CI*: 97.2%-100%)

Relative Specificity: 99.3% (95%CI*: 97.6%-99.9%)

Accuracy: 99.5% (95%CI*: 98.3%-99.9%)

*Confidence Intervals

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

HBeAg

Relative Sensitivity: 98.4% (95%CI*: 94.4%-99.8%)

Relative Specificity: 98.6% (95%CI*: 96.7%-99.5%)

Accuracy: 98.5% (95%CI*: 97.0%-99.4%)                  

*Confidence Intervals

HBeAb

Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)

Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)

Accuracy: 97.1% (95%CI*: 95.1%-98.4%)               

*Confidence Intervals

HBcAb

Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)

Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)

Accuracy: 97.0% (95%CI*: 95.0%-98.3%)                 

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive, high positive of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb. 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, high positive of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb in 15 independent assays. Three different lots of ACCU-TELL^® HBV Rapid 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 99% of the time.

Cross-reactivity

ACCU-TELL^® HBV Rapid 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^® HBV Rapid 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^® HBV Rapid Test Cassette (Serum/Plasma) is for professional in vitro diagnostic use only. The test should be used for the detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma specimen. Neither the quantitative value nor the rate of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb concentration can be determined by this qualitative test.

2. ACCU-TELL^® HBV Rapid Test Cassette (Serum/Plasma) will only indicate the presence of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb 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.

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