The HCV Ab Rapid Screen Test Cassette (Whole Blood/Serum/Plasma) is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM, and IgA) anti- Hepatitis C virus (HCV) in human whole blood, serum or plasma.
Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. 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. HCV Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a whole blood, serum or plasma specimen. The test utilizes a combination of recombinant antigen to selectively detect elevated levels of HCV antibodies in whole blood, serum or plasma.

Quick Details

Product name:Hepatitis C (HCV Ab) Rapid Screen Test
Type:Pathological Analysis Equipment
Instrument classification:Class II
CertificateCE/ ISO
Storage2’C-30’C
Packing:Pouch/box
Format / SizeCassette: 3.0mm 4.0mm
Accuracy:99.6%
Function:Detect Hepatitis C 

Antigen Information

Gene Symbols:Ab

Assay Format

Number of Targets Detected:1
MethodologyChromatographic Immunoassay
Specimen:Serum/Plasma/Whole Blood
Design Principle:Sandwich-based
Method of Detection:Colloidal Gold
Assay TypeQualitative Detection
Solid Support:Lateral Flow
Principle The HCV Ab Rapid Test Cassette is a lateral flow chromatographic immunoassay based on the principle of the double antigen—sandwich technique. The test cassette consists of: 1) a burgundy colored conjugate pad containing HCV antigens conjugated with colloidal gold (HCV Ag conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated HCV antigens, and the C band is pre-coated with goat anti-rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. The antibodies: either the IgG, the IgM, or the IgA, to HCV if present in the specimen will bind to the HCV Ag conjugates. The immunocomplex is then captured on the membrane by the pre-coated HCV antigens, forming a burgundy colored T band, indicating a HCV Ab positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless the presence of any antibodies to HCV. Otherwise, the test result is invalid and the specimen must be retested with another device.  
TEST PROCEDURE: 1) Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible. Place the test strip on a clean and level surface.   2) For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen pad of the test strip, then start the timer. See illustration below. 3) For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 35μl) to the specimen pad of the test strip, then add 2 drops of buffer (approximately 70μl) and start the timer.    4) Wait for the coloured line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.   Important: In order to prevent an incorrect reading, do not read the test results after more than 8 minutes. If the test is read after 8 minutes, the intensity of the coloured lines may change or a new line may appear. To avoid confusion, discard the test device after interpreting the result

PRODUCT SPECIFICATIONS

Hepatitis C (HCV Ab) Rapid Screen Tests are supplied for both the professional Laboratory Environment and also Point of Care (POC) situations in remote settings. Components of each for of kit set are:

COMPONENTS PROVIDED

POC – HCV Ab test kits are individually packed testing kits that incorporate the required components to perform a test in remote settings by medical professionals, first responders and trained personal. The POC – HCV Ab test kit includes the following components:

  • Test Cassette
  • Buffer Solution
  • Lancet
  • Transfer Pipette
  • Prep Pad

Laboratory Environments require the testing device and supporting reagents and therefore the test kit comprises of:

EnvironmentsTotal Number of TestsMOQ
Laboratory40 Tests Per Box (Test Cassettes and Buffer Solution only)5 Boxes
Point of Care20 Complete Test Kits per box (Including Lancets, Alcohol Swabs and Pipettes)5 Boxes