Accu-Tell® HBsAg/HCV Combo Rapid Test Cassette (Serum/Plasma)

Accu-Tell®HBsAg/HCV Combo Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) and antibodies to Hepatitis C Virus in serum or plasma

CATALOG

Product Name	Specimen	Catalog No.	Quantity per box	Certificate
HBsAg/HCV Combo Cassette	Serum/Plasma	ABT-IDT-B56	40T/20T

KEY POINTS

Detection for:Hepatitis B surface antigen (HBsAg) and antibodies to Hepatitis C Virus in serum or plasma.

Specimen volume:For HBsAg Rapid Test: 75μL Serum or Plasma Specimen.

For HCV Rapid Test:25μL Serum or Plasma Specimen.

Reading time:10 minutes

HBsAg:

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%)

HCV:

Relative sensitivity: 99.1% (95%CI*: 94.9%~100.0%);

Relative specificity: 99.5% (95%CI*: 98.6%~99.9%);

Accuracy: 99.4% (95%CI*: 98.6%~99.8%).

INTRODUCTION

The Serum/Plasma) is a rapid test to qualitatively detect the presence of HBsAg in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in serum or plasma.

The HCV Test (Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a serum or plasma specimen. The test utilizes colloid gold conjugate and recombinant HCV proteins to selectively detect antibody to HCV in serum or plasma. The recombinant HCV proteins used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.

INTENDED USE

ACCU-TELL®HBsAg/HCV Combo Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) and antibodies to Hepatitis C Virus in serum or plasma

TEST PROCEDUREof

For HBsAg Rapid Test:Hold the dropper vertically and transfer 3 drop of serum or plasma (approximately 75μL) to the specimen area, and start the timer, see illustration below.

For HCV Rapid Test:Hold the dropper vertically and transfer 1 drops of serum or plasma (approximately 25μL) to the specimen area, then add 2 drops of buffer (approximately 80μL), and start the timer. See illustration below.

We also produce and .

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

HBsAg

The HBsAg 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 The HBsAg Rapid Test (Serum/Plasma). The test can detect 1 PEI ng/ml of HBsAg in serum/plasma Antibodies used for the HBsAg Test (Serum/Plasma) were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of the HBsAg Test (Serum/Plasma) was also tested with laboratory strains of Hepatitis A and Hepatitis C. They all yielded negative results.

Method		EIA		Total Results
HBsAg Test (Serum/Plasma)	Results	Positive	Negative
	Positive	205	3	208
	Negative	0	310	310
Total Results		205	313	518

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

HCV

The recombinant antigen used for the (Serum/Plasma) is encoded by genes for both structural (nucleocapsid) and non-structural proteins. The HCV Test Cassette (Serum/Plasma) has passed a seroconversion panel and compared with a leading commercial HCV EIA test using clinical specimens.

The results show that the relative sensitivity of the HCV Test Cassette (Serum/Plasma) is 99.1%, and the relative specificity is 99.5%.

Method		EIA		Total Results
HCV Test (Serum/Plasma)	Results	Positive	Negative
	Positive	107	3	110
	Negative	1	599	600
Total Result		108	602	710

Relative sensitivity: 99.1% (95%CI*: 94.9%~100.0%);

Relative specificity: 99.5% (95%CI*: 98.6%~99.9%);

Accuracy: 99.4% (95%CI*: 98.6%~99.8%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 20 replicates of four different specimens containing different concentrations of HBsAg and HCV antibody. The negative, positive values were correctly identified 100% of the time.

Inter-Assay

Between-run precision has been determined by 20 independent assays on the same four different specimens containing different concentrations of HBsAg, and HCV antibody. Three different lots of ACCU-TELL®HBsAg/HCV Combo Cassette (Serum/Plasma) have been tested over a 3-month period using above negative and positive specimens. The specimens were correctly identified 100% of the time.

Cross-reactivity

The (Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella, HCV, HEV and TOXO positive specimens. The results showed no cross-reactivity

The HCV Test (Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to HBsAg, HCV antibody negative and positive specimens.

Acetaminophen:	20 mg/dL	Caffeine:	20 mg/dL
Acetylsalicylic Acid:	20 mg/dL	Gentisic Acid:	20 mg/dL
Ascorbic Acid:	2g/dL	Albumin:	2 g/dL
Creatin:	200 mg/dL	Hemoglobin:	1000mg/dL
Bilirubin:	1g/dL	Oxalic Acid:	60mg/dL

None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

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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