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

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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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