ACCU-TELL ANTI-HCV SERUM / WHOLE BLOOD TEST

Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

 

CATALOG

INTENDED USE

                                                                                PERFORMANCE CHARACTERISTICS

                                                                                BIBLIOGRAPHY

 

CATALOG

Catalog No.                    Product Name

ABT-IDT-A11                  Anti-HCV Serum Strip

ABT-IDT-B11                  Anti-HCV Serum Cassette

ABT-IDT-A12                  Anti-HCV Whole Blood Strip

ABT-IDT-B12                  Anti-HCV Whole Blood Cassette

 

Accu-Tell ^® Rapid Anti-HCV Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma(Whole blood). This test is a screening test and all positives must be confirmed using an altemate test such as Western Blot.The test is intended for healthcare professional use only.

 

The general method of detecting infection with HCV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with Western Blot. Accu-Tell ^® Rapid Anti-HCV Test is a simple, visual qualitative test that detects antibodies in human serum or plasma(Whole blood). This test is based on immunochromatography and can give a result within 15 minutes.

 

The assay starts with a sample applied to the sample well and add provided sample diluent immediately.The HCV antigen -colloidal gold conjugate embedded in the sample pad reacts with the HCV antibody present in serum or plasma sample forming conjugate/HCV antibody complex. As the mixture is allowed to migrate along the test strip, the conjugate/HCV antibody complex is captured by a antibody-binding protein A immobilized on a membrane forming a colored test band in the test region. A negative sample does not produce a test line due to the absence of colloidal gold conjugate/HCV antibody complex. The antigens used in the test are recombinant proteins corresponding to highly immunoreactive regions of HCV. A colored control band in the control region appears at the end of test procedure regardless of test result. This control band is the result of colloidal gold conjugate binding to an anti-HCV antibody immobilized on the membrane. The control line indicates that the colloidal gold conjugate is functional. The absence of the control band indicates that the test is invalid.

1.  All positive results must be confirmed by an alternative method.

2. Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens.

3.  Devices used for testing should be autoclaved before disposal.

4.  Do not use kit materials beyond their expiration dates.

5.  Do not interchange reagents from different lot of kit.

1.   Collect serum or plasma specimens following regular clinical laboratory procedures.

2.  Storage: A specimen should be refrigerated if not used the same day of collection. Specimens should be frozen if not used within 3 days of collecting. Avoid freezing and thawing the specimens more than 2-3 times before using. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.

Read the entire procedure carefully prior to performing any tests. Allow test devices and serum samples to equilibrate to room temperature (18-30°C) prior to testing. Remove test from the sealed pouch.

1.  Dispense 1 drop (10μl) of serum or plasma to the circular sample well of the test cassette;

2.  Add two (2) drops of Sample Diluent to the sample well immediately after the specimen is added.

3.  Interpret test results at 15 minutes.

1.  Dispense 1 drop (10μl) of serum or plasma to the upper edge of the sample pad of the test strip.

2.  Add two drops of Sample Diluent to the lower edge of the sample pad after the specimen is added.

3.  Interpret test results at 15 minutes.

Note:

1.  Applying sufficient amount of sample diluent is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of diluent to sample well.

2. The positive results could appear as soon as 1 minute for a sample with high levels of HCV antibodies.

3.  Do not interpret result after 20 minutes.

Negative: Only a single red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

Positive: Two distinct red lines will appear, one in the test region (T) and another in the control region (C).

Invalid: A total absence of colored lines in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.

NOTES: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible.

A procedural control is included in the test. A red line appearing in the control region (C) is considered as internal positive procedural control. A clear background in the result window is considered as internal negative procedural control.

1. Only samples that are clear and with good fluidity can be used in this test.

2. Fresh samples are best but frozen samples can be used. If a sample has been frozen, it should be allowed to thaw in a vertical position.

3. Do not agitate the sample. Insert a pipette just below the surface of the sample to collect the specimen.

Store as packaged in the sealed pouch at room temperature (2-30 ^oC) for duration of shelf life. The test cassette should be kept away from direct sunlight, moisture and heat.

1. Specificity:

The specificity of the Rapid Anti-HCV Test is based on clinical studies using confirmed negative serum samples from blood bank and hospital patients in USA (66 samples) and China (90 samples). The studies were performed comparing the results from Rapid Anti-HCV test and that from Abbott’s ELISA as a reference test. The overall specificity was found to be 97 – 99%.

2. Sensitivity:

In the same studies mentioned above, Rapid Anti-HCV Test was evaluated with 61 confirmed positive serum samples (USA: 31 samples and China: 30 samples). All 61 samples were found reactive.

1. Choo Q-L, Weiner AJ, Overby LR, Kuo G, Houghton M. Hepatitis C virus: the major causative agent of viral non-A, non-B hepatitis. Br Med Bull 1990;46:423-41.

2. Alter HJ, Purcell RH, Shih JW, Melpolder JC, Houghton M, Choo Q-L, Kuo G. Detection of antibody to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis. A Engl J Med 1989;321: 1494-500.

3. Esteban JI, Gonzalez A, Hernandez JM et al. Evaluation of antibodies to hepatitis C virus in a study of transfusion-associated hepatitis. N Engl J Med 1990;323:1107-12.

4. Alter HJ, Holland PV, Morrow AG et al. Clinical and serological analysis of transfusion-associated hepatitis. Lancet 1975;2:838-41.

 

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.