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RAPID ANTI-HCV SERUM TEST
| Catalog No. | Product Name | Specimen | Note |
| ABT-IDT-A11 | Anti-HCV Serum Strip | Serum | |
| ABT-IDT-B11 | Anti-HCV Serum Cassette | Serum | |
| ABT-IDT-A12 | Anti-HCV Whole Blood Strip | Whole Blood | |
| ABT-IDT-B12 | Anti-HCV Whole Blood Cassette | Whole Blood |
INTENDED USE
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. This test is a screening test and all positives must be confirmed using an alternate test such as Western Blot. The test is intended for healthcare professional use only.
PERFORMANCE CHARATERISTICS
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%.
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.
SPECIMEN COLLECTION
1. Collect serum or plasma specimens follwing 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 collectiong. 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.
TEST PROCEDURE
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 (10ul) 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.
INTERPRETATION OF RESULTS
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 tet 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 occured.
NOTES: It is normal to have a slightly lightened control band with very strong postive samples as long as it is distinctly visible.
ABOUT US
we have exported our in vitro rapid diagnostic test and lab equipment to over 50 countries.
Our Aim:
——Let every family benefit from our convenient and reliable diagnostic products and services.
——Let our lab equipment be used in every laboratory of the world.
Our Values on Quality:
——Delivers customer value in all in all projects, services and processes;
——Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made;
——Drives QMS results to the bottom line in terms of defect reduction and financial benefits;
——Allocates resources to achieve quality execution
Our product have got ISO13485 & ISO9001 certification.
If you need high quality product at competitive price, good after-sale service, good supply chain —— Please contact us without hesitation or visit our website at www.accubiotech.com
rapid anti-hcv serum test kits