Hepatitis C Virus Home Testing Kits , Reliable Blood Home Health Drug Test CE

99% accuracy HCV Home Testing kits, full individual package, home test use, detecting Hepatitis C virus

INTENDED USE:

The HCV Home Testing kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus in blood for the self test at home.

INTRODUCTION

The current diagnosis of HCV infection relies primarily on the detection of HCV specific antibodies and/or clinical symptoms not attributed to Hepatitis A, B, D or E. The transmission of HCV has been reported to be via transfusion of contaminated blood or blood products as well as shared needles and close personal contact with an infected individual.

The HCV Home Testing kit is a rapid test to qualitatively detect the presence of antibodies to HCV in a serum or plasma sample. The test utilizes a combination of protein A coated particles and recombinant HCV proteins to selectively detect antibodies to HCV in serum or plasma. The recombinant HCV proteins used in the test kit are encoded with the genes for both structural (nucleocapsid) and non-structural proteins.

The availability of a rapid, simple test for HCV will enable HCV testing in urgent situations such as transplant and grafting procedures. Such a test will also allow small private laboratories to perform the assay in-house rather than referring the sample to the reference centre. The HCV Rapid Test may also be utilized by large reference centres or blood transfusion centres as a second assay when they are required to perform two methods on each reactive sample.

PRINCIPLE

The HCV Rapid Test utilizes a combination of protein A coated particles and recombinant antigens derived from HCV structural and non-structural sequences. The presence of antibodies is revealed by a reaction of antibodies with protein A coated particles and subsequent binding to recombinant HCV antigen that generates a red line on the membrane.

An internal sample/ reagent addition control is also included in the device to minimize the risk of a false negative reaction due to operational errors.

TEST PROCEDURE

Ensure that test device and sample are brought to room temperature (15oC - 30oC) before testing. Remove device from foil pouch and use within one hour. Place device on a clean and level surface.

1. Hold the sample applicator vertically and draw the sample up to the Fill Line as shown in the illustration below (approximately 5 µl). Transfer the sample to Sample well (S) of test device.

2. Then add 2 full drops of buffer (approximately 80 µl). Avoid air bubbles in the specimen well.

3. Start the timer and read the results at 10 minutes. Do not read the results after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity

The HCV Home Testing kit has been tested with a seroconversion panel and compared with leading commercial HCV EIA test using clinical samples.

Specificity

The recombinant antigens used for the HCV Home Testing kit are encoded by genes for both structural (nucleocapsid) and non-structural proteins. The HCV Home Testing kit is highly specific for antibodies to Hepatitis C Virus compared with a leading commercial HCV EIA test.

Relative Sensitivity: 96.8%

Relative Specificity: 99.0%

Accuracy: 98.9%