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

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

Rapid Dengue Test

CATALOG

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 HBsAg Test (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 PROCEDURE of HAV Rapid Test

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the Cassette on a clean and level surface.

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.

3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.

We also produce HIV Type 1 Antibodies Rapid Test and HIV Ag/Ab Combo Rapid Test.

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.

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 HCV Test Cassette (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%.

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 HBsAg Test (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.

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

LIMITATIONS

1. This test is for in vitro diagnostic use only.

2. This test has been developed for testing serum /plasma specimens only. The performance of the test using other specimens has not been substantiated.

3. This test is a qualitative screening assay. It is not designed to determine the quantitative concentration of HBsAg or HCV antibody,

4. The HBsAg Rapid Test cannot detect less than 1 PEI ng/ml of HBsAg in specimens.

5. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

6. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is recommended. A negative result at any time does not preclude the possibility of HBsAg and/or Hepatitis C Virus.

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