The Hepatitis C Rapid Screen Test is a screening test for the qualitative detection of the anti-HCV antibodies in whole blood, as an aid in the diagnosis of Hepatitis C infection. Hepatitis C is a liver disease. The virus can cause both acute and chronic hepatitis, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. The most common routes of hepatitis C transmission are: the reuse or inadequate sterilization of medical equipment, especially syringes and needles in healthcare settings, the transfusion of unscreened blood and blood products, and the shared use of injection equipment between drug users.
- Do not use the test kit beyond the expiration date.
- Do not use the kit if the pouch is punctured or not well sealed.
- For in vitro use only. Do not swallow.
- All specimens from the body should be treated as potentially infectious.
- Contaminated blood may give incorrect test results.
- Discard after first use. The test cannot be used more than once.
- DISPOSAL: The used-device has the risk of infection. Please dispose all used contents properly.
HEPATITIS C RAPID SCREEN TEST CONTENTS
Each Kit Contains:
- Hepatitis C test card, individually foil pouched with a desiccant (silicon gel)
- Plastic dropper
- Sample diluent
- Safety lancet
- Alcohol swab
- Package insert
Material Required But Not Provided:
STORAGE AND STABILITY
The kit must be stored between 2-30OC.
Do not open pouch until you are ready to test the sample.
ASSAY PROCEDURES FOR FINGER BLOOD
- Bring the hepatitis C test card, sample diluent, alcohol swab, safety lancet and plastic dropper to room temperature.
- Take out the test card from the sealed pouch.
- To perform the test, please follow the steps from picture 1 to picture 8.
ASSAY PROCEDURES AT CLINICS
- Bring all reagents and specimens to room temperature.
- Remove the hepatitis C test card from the foil pouch and place it on a clean and dry surface.
- Identify the test card for each specimen or control.
- For whole blood/serum/plasma testing: Dispense one drop (30μl) of sample or control into the sample well on the card using the plastic dropper provided, then add two drops (80μl) of sample diluent into the same well.
- Interpret test results at 15 minutes. A positive result may be interpreted early, however read any negative at 15 minutes to ensure sample is negative and not a low concentration of Anti-HCV. Do not interpret the result after 20 minutes.
It is recommended to run a known positive control and negative control in each performance to ensure the assay procedure.
READING THE TEST RESULTS
- Positive: Both purplish read test band and purplish read control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
- Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
- Invalid: There should always be a purplish red control band in the control region regardless of test result. If control band is not seen, the test is considered invalid. Repeat the test using a new test device.
Note: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible.
- Specificity: The specificity of the Hepatitis C Rapid Screen Test is based on clinical studies using confirmed negative serum samples from blood banks and hospital patients in the USA (66 samples) and China (90 samples). The studies were performed comparing the results from the Hepatitis C Rapid Screen Test and that from the Abbott's ELISA as a reference test. The overall specificity was found to be 97 - 99%.
- Sensitivity: In the same studies mentioned above, the Hepatitis C Rapid Screen Test was evaluated with 61 confirmed positive serum samples (USA: 31 samples and China: 30 samples). All 61 samples were found reactive.
This test is a screening test and all positives must be confirmed using an alternate test such as a Western Blot performed by a doctor or clinic to confirm the diagnosis. This test is intended for field and professional use only.
- Choo Q-L, Weiner AJ, Overby LR, Kuo G, Houghton Hepatitis c· virus: the major causative agent of viral non-A, non-B hepatitis. Br Med Bull 1990;46:423-41.
- 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.
- 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.
- Alter HJ, Holland PV, Morrow AG et al. Clinical and serological analysis of transfusion-associated Lancet 1975;2:838-41.