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

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Accu-Tell® HBsAg/HCV/HIV/Syphilis Combo Cassette (Serum /Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen(HBsAg),antibodies to Hepatitis C Virus, antibodies to HIV type 1, type 2 and syphilis antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per box
HBsAg/HCV/HIV/Syphilis Combo CassetteSerum/PlasmaABT-IDT-B7830T/15T


KEY POINTS

Detection for: Hepatitis B surface antigen(HBsAg),antibodies to Hepatitis C Virus, antibodies to HIV type 1, type 2  and syphilis antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma..

Reading time: 10 minutes

Relative Sensitivity & Relative Specificity & Accuracy:

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%)  

*Confidence Intervals

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%).                    

*Confidence Intervals

HIV:

Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%); 

Relative specificity: 99.88% (95%CI*: 99.57%~99.99%);

Accuracy: 99.89% (95%CI*: 99.60%~99.99%).   

*Confidence Intervals

Syphilis:

Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);  

Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);

Accuracy:99.8%(95%CI*:98.2%~100.0%).

*Confidence Intervals

 

INTRODUCTION

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg.

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis.

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope.

Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane

 

INTENDED USE

ACCU-TELL® HBsAg/HCV/HIV/Syphilis Combo Rapid Test Cassette (Serum /Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen(HBsAg),antibodies to Hepatitis C Virus, antibodies to HIV type 1, type 2  and syphilis antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma..

 

TEST PROCEDURE

HBsAg-HIV-HCV-Syphilis Rapid Test Procedure.png

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

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 test cassette on a clean and level surface. Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50µL) to the specimen area, then add 1 drop of buffer (approximately 40µL), respectively. Start the timer. See the illustration above.

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.


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

HBsAg

Accu-Tell® 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 Accu-Tell® HBsAg Test (Serum /Plasma). The test can detect 1 PEI ng/ml of HBsAg in serum/plasma.

Antibodies used for Accu-Tell® HBsAg Test (Serum /Plasma) were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of Accu-Tell® HBsAg Test (Serum /Plasma) was also tested with laboratory strains of Hepatitis A and Hepatitis C. They all yielded negative results.

MethodEIATotal Results
Accu-Tell® HBsAg Test   (Serum /Plasma)ResultsPositiveNegative
Positive2053208
Negative0310310
Total   Results205313518

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 Accu-Tell® HCV Test (Serum /Plasma) is encoded by genes for both structural (nucleocapsid) and non-structural proteins. Accu-Tell® Rapid HCV Test (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 Accu-Tell® HCV Test (Serum /Plasma) is 99.1%, and the relative specificity is 99.5%.

MethodEIATotal Results
Accu-Tell® HCV Test (Serum /Plasma)ResultsPositiveNegative
Positive1073110
Negative1599600
Total   Result108602710

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

HIV 1.2

Accu-Tell® HIV 1.2 Test (Serum /Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of Accu-Tell® HIV 1.2 Test (Serum /Plasma)) is >99.99% and the relative specificity is 99.88%.

MethodELISATotal   Results
Accu-Tell® HIV 1.2 Test (Serum /Plasma)ResultsPositiveNegative
Positive1302132
Negative016831683
Total   Result13016851815

Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%); 

Relative specificity: 99.88% (95%CI*: 99.57%~99.99%);

Accuracy: 99.89% (95%CI*: 99.60%~99.99%).   

*Confidence Intervals

Syphilis

Accu-Tell® Syphilis Test (Serum /Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens. The results show that the relative sensitivity of Accu-Tell® Syphilis Test(Serum /Plasma) is >99.9% and the relative specificity is 99.7%.

MethodELISATotal Results
Accu-Tell® Syphilis Test (Serum   /Plasma)ResultsPositiveNegative
Positive1301131
Negative0299299
Total Result130300430

Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);  

Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);

Accuracy:99.8%(95%CI*:98.2%~100.0%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 20 replicates of four different specimens containing different concentrations of HBsAg, HCV antibody, HIV 1.2 antibody and syphilis 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, HCV antibody, HIV 1.2 antibody and syphilis antibody. three specimens: a negative, a HCV low titer positive and a HCV high titer positive.  Three different lots of ACCU-TELL® HBsAg/HCV/HIV/Syphilis 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

Accu-Tell® 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

Accu-Tell® 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.

Accu-Tell® HIV 1.2 Test (Serum /Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV,Syphilis, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Accu-Tell® Syphilis Test (Serum /Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV,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, HIV 1.2 antibody and syphilis antibody negative and positive specimens.

Acetaminophen:20 mg/dLCaffeine:20 mg/dL
Acetylsalicylic Acid:20 mg/dLGentisic Acid:20 mg/dL
Ascorbic Acid:2g/dLAlbumin:2 g/dL
Creatin:200 mg/dLHemoglobin:1000mg/dL
Bilirubin:1g/dLOxalic Acid:60mg/dL

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, HCV antibody, HIV 1.2 antibody or syphilis antibody.

4. Accu-Tell® HBsAg Test (Serum /Plasma) 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 and/or HIV1.2 and/or syphilis infection.

 

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