HCV Rapid Test Device Package Insert
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. Antibody to HCV is found in over 80% of patients with well‐documented non‐A, non‐B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross‐reactivity and to increase the sensitivity of the HCV antibody tests.
The HCV Rapid Test Device (Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
|Individually packed test devices||Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions|
|Disposable pipettes||For adding specimens use|
|Buffer||Phosphate buffered saline and preservative|
|Package insert||For operation instruction|
Materials Required But Not Provided
|Specimen collection container||For specimens collection use|
|Timer||For timing use|
|Centrifuge||For preparation of clear specimens|
★ For professional in vitro diagnostic use only.
★ Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
★ This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
★ Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
★ Read the entire procedure carefully prior to performing any tests.
★ Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
★ Do not interchange or mix reagents from different lots.
★ Humidity and temperature can adversely affect results.
★ The used testing materials should be discarded in accordance with local, state and/or federal regulations.
Storage and Stability
✽ The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
✽ The test must remain in the sealed pouch until use.
✽ Do not freeze.
✽ Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.
Specimen Collection and Storage
✔ The HCV Rapid Test Device (Serum/Plasma) is intended only for use with human serum or plasma specimens.
✔ Only clear, non‐hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated with soonest possible opportunity to avoid hemolysis.
✔ Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2‐8°C for up to 3 days. For long term storage, specimens should be kept below ‐20°C.
✔ Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
✔ Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
✔ Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2.Transfer 2 drops (approximately 50 L) of serum/plasma and 1 drop buffer to the specimen well of the device with a disposable pipette in the kit, and then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
3.Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Interpretation of Results
|* A colored band appears in the control band region (C) and another colored band appears in the T band region|
|One colored band appears in the control band region (C). No band appears in the test band region (T).|
|Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor|
1.The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2.Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
★ Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.
★ External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
Limitations of the Test
1.The HCV Rapid Test Device (Serum/Plasma) is for professional in vitro diagnostic use, and should be used for the qualitative detection of antibodies to HCV only.
2.The HCV Rapid Test Device (Serum/Plasma) will only indicate the presence of HCV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HCV viral infection.
3.If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime rule out the existence of HCV antibodies in blood, because antibodies may be absent or below the minimum detection level of the test.
4.Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Table: HCV Rapid Test vs. EIA
|Relative Sensitivity: 99.8% (99.0%-100.0%)*
Relative Specificity: 99.9% (99.8%-100.0%)*
Overall Agreement: 99.9% (99.7%-99.9%)*
*95% Confidence Interval
HCV Rapid Test
1.Choo, Q.L., G. Kuo, A.J. Weiner, L.R. Overby, D.W. Bradley, and M. Houghton. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science 1989; 244:359
2.Kuo, G., Q.L. Choo, H.J. Alter, and M. Houghton. An assay for circulating antibodies to a major etiologic Virus of human non-A, non-B hepatitis. Science 1989; 244:362
3.van der Poel, C. L., H.T.M. Cuypers, H.W. Reesink, and P.N.Lelie. Confirmation of hepatitis C Virus infection by new four-antigen recombinant immunoblot assay. Lancet 1991; 337:317
4.Wilber, J.C. Development and use of laboratory tests for hepatitis C infection: a review. J. Clin. Immunoassay 1993; 16:204