HCV(Hepatitis C Virus) Antibody Rapid Test Kit

For the Qualitative Detection of HCV Antibodies in serum/plasma and whole Blood

Main Features

☀ High Sensitivity

☀ High Specificity

☀ Simple: No Instrument Required

☀ Reliable: high accurate, early detection of the presence of HCV

☀ Convenient: Room Temperature Storage, Built-In Control line

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

☀ Certified by Authoritative Certification System and Standards

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

Newscen HCV Antibody Rapid Test is for the detection of antibodies to Hepatitis C type virus(HCV) in human serum, plasma or whole blood collected from vein or fingertip. It is intended for use in medical institutions by trained staff.

Principle

HCV(Core and NS 3) specific recombinant antigens are precoated on to the membrane as the capture reagent on the test zone. During the test, specimen is allowed to react with the colloidal gold particles,which have been conjugated with HCV specific recombinant antigens. Antibodies to HCV, if present, will specifically bind to colloidal gold-antigen complex.

When the colloidal gold-antigen-antibody complexes move to the test zone, they will specifically bind to the precoated antigens. At the same time, a red colored Iine will develop in the test zone.

Absence of this red colored line in the test zone suggests a negative result. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of antibodies to HCV.

Materials Required But Not Provided

☀ Timer or stopwatch

☀ Blood collection devices, for the testing of venipuncture whole blood, serum or plasma

☀ Biohazard disposal container

☀ Disposable gloves

For finger stick samples, the following materials are required:

Alcohol pad

Sterile lancet

Sterile gauze or cotton

Reagents and Materials Provided

Each kit contains:

☀ 40 test cassettes(individually pouched)

☀ Each pouch contains one cassette with one desiccant bag

☀ One bottle of diluent buffer(5mL)

☀ 40 disposable plastic droppers

☀ Instruction for use

Assay Procedure

☀ Place the test cassette on flat surface. Before unseal the pouch, allow the test cassette to reach laboratory temperature(15-30°C) .Use it immediately once unsealed.

☀ Open the pouch and add1dropor35pL of specimen into the sample well(S) .

☀ After adding the specimen, add1dropor35pL of diluent buffer vertically into the sample well(s) immediately.

☀ Avoid dropping specimen or diluent buffer in the observation window.

☀ Do not allow the diluent buffer bottle touch the sample well when dropping the diluent buffer so as to prevent the cross contamination with the specimen.

☀ Observe the result in 30 minutes once the diluent buffer added.

Interpretation of Results

Note:'C'-Control line； T'-Test line

Negative: No redline appear in 30 minutes in the test zone(T), only a redline in the control zone(C) ,which indicates that the absence of HCV antibodies or the concentration of antibodies is too low(i.e., window period of infection) .

Positive: One redline in the control zone(C) and one redline in the test zone(T) .This indicates the specimen contains HCV antibodies.

Invalid: If no redlines appear, the test is invalid. Discard the test cassette and perform with new cassette.

Built-In Control

Newscen HCV Antibody Rapid Test has a built-in procedural control that demonstrates assay validity. A redline appeared on the control zone(C) indicates that the test runs correctly.

Warning

For invitro diagnostic use ONLY

Storage

Newscen HCV Antibody Rapid Test should be stored at 4-30°C(do not freeze) for 24 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible(within 1hour) to avoid test cassette from becoming moist. Do not use the test beyond the indicated expiration date.

The diluent buffer should be stored at 4-30°C(do not freeze) for 24 months from the date of manufacture. After the diluent is opened, it will be stored for 24 months according to the validity period.