Test Format: Strip/CassetteSpecimen: Whole Blood/Serum/PlasmaExpiry date: 24 MonthsFunction: Rapid testStorage: 2-30 centigrade
IVD Infections diseases Hepatitics C Virus HCV rapid test kit HCV test strip
Intended Use
The reagent is used to detect the Hepatitis C Virus Antibody in serum / plasma qualitatively.
Test Principle
The test utilizes antibodies including a recombinant protein mixed HCV antigen and rabbit anti-HCVantibody on the nitrocellulose membrane with colloidal gold marked mixed HCV antigen as a mark tracer. The reagent is used to detect the HCV antibody in serum / plasma according to the principle of double antigen sandwich method and gold
immunochromatography assay.
The sample mixing up HCV antigen–marker move along the membrane to the T line, and form the Tline when the sample contains HCV antibody,which a positive result. Conversely, it is a negativeresult.
Main Components
Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent paper and PVC board.
Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry place, valid for 24 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.
Sample Requirement
1. The reagent can be used for the serum, plasma samples. After collection, separate the serum and
plasma as soon as possible, in order to avoid hemolysis.
2. A serum / plasma sample must be collected in a clean and dry container. EDTA, sodium citrate,
sodium oxalate, heparin can be used as the anticoagulants. Detect immediately after collecting
blood. If blood coagulation occurs, serum samples are suggested to use.
3. Samples may be stored at 2-8℃ for 3 days prior to assay, and at -20 ℃.
Test Procedure
Instructions must be read entirely before taking the test. Allow the test device controls to
equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity: 20%~90%, Temp:10℃-50℃)
Strip and Cassette:
1. Take off the outer packing, put the strip/cassette onto the desk with the sample adding area of the strip/ the sample window of the cassette up.
2. Serum / Plasma: Drop 1 drop (25ul) serum/plasma vertically into the sample adding area of the strip/the sample hole of cassette. Add 2 drops (80-100ul) of sample buffer into the sample adding area of the strip/the sample hole of cassette.
3. Observe the test results immediately within 10-20 minutes, the result is invalid over 20 minutes.
Result Judgment
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
NEGATIVE: One red line appears in the control region(C). No apparent red or pink line appears in the test region (T).
INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Precaution
1. For IN VITRO diagnose only.
2. Do not use after the expiration date.
3. The test result is invalid over
Product Name | Production Information | ||||
Catalog No. | Specimen Used | Test Format | Kit Size | Sensitivity | |
HCV Hepatitis C Virus Ab Test | H128-11W | Whole blood/Serum/Plasma | Strip | 50 pcs per box | 99.00% |
HCV Hepatitis C Virus Ab Test | H128-23W | Whole blood/Serum/Plasma | Cassette | 25 pcs per box | 99.00% |
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