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

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.

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

HBV Cassette

Serum/Plasma

ABT-IDT-E65

30T/15T

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®(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.

TEST PROCEDURE

PERFORMANCE CHARACTERISTICSof

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

Method

EIA

Total Results

HBsAg Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

128

2

130

Negative

0

300

300

Total Results

128

302

430

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

Method

RIA

Total Results

HBsAb Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

231

3

234

Negative

0

180

180

Total Results

231

183

414

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

Method

RIA

Total Results

HBeAg Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

125

5

130

Negative

2

350

352

Total Results

127

355

482

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

Method

EIA

Total Results

HBeAb Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

118

8

126

Negative

5

318

323

Total Results

123

326

449

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

Method

EIA

Total Results

HBcAb Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

327

5

332

Negative

10

150

160

Total Results

337

155

492

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

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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. We are .

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



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