page

product

Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit (WB/S/P) – HEO

Short Description:


Product Detail

Product Tags

Related Video

Feedback (2)

We stay with the basic principle of "quality initially, services first, steady improvement and innovation to fulfill the customers" for your management and "zero defect, zero complaints" as the quality objective. To perfect our company, we give the goods while using the good high-quality at the reasonable selling price for Igm And Igg Difference, Nsi Ag Test, Dengue Test Igm Positive Means, We are one of the largest 100% manufacturers in China. Many large trading companies import products from us, so we can give you the best price with the same quality if you are interested in us.
Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit (WB/S/P) – HEO Detail:

HCV Rapid Test Cassette/Strip/kit (WB/S/P)

hcv rna
anti hcv test
hcv ab
hcv blood test
hepatitis c test

[INTENDED USE]

The HCV Rapid Test Cassette/Strip is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus in Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Hepatitis C Virus.

 [SUMMARY]

Hepatitis C virus (HCV) is a single stranded RNA virus of the Flaviviridae family and is the causative agent of Hepatitis C. Hepatitis C is a chronic disease affecting approximately 130-170 million people worldwide. According to the WHO, annually, more than 350,000 people die from hepatitis C-related liver diseases and 3-4 million people are infected with HCV. Approximately 3% of the world’s population is estimated to be infected with HCV. More than 80% of HCV-infected individuals develop chronic liver diseases, 20-30% develop cirrhosis after 20-30 yr, and 1-4% die from cirrhosis or liver cancer. Individuals infected with HCV produce antibodies to the virus and the presence of these antibodies in the blood indicates present or past infection with HCV.

[COMPOSITION] (25sets/ 40sets/50sets/customized specification are all approval)

The test cassette/strip contains a membrane strip coated with combination HCV antigen on the test line, rabbit antibody on the control line, and a dye pad which contains colloidal gold coupled with recombine HCV antigen. The quantity of tests was printed on the labeling.

Materials Provided

Test cassette/strip

Package insert

Buffer

Materials Required But Not Provided

Specimen collection container

Timer

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. The HCV Rapid Test Cassette/Strip detects antibodies to HCV infection in Whole Blood/Serum/Plasma. The test utilizes a combination of protein A coated particles and recombinant HCV proteins to selectively detect antibodies to HCV. The recombinant HCV proteins used in the test are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.

[PRINCIPLE]

The HCV Rapid Test Cassette/Strip is an immunoassay based on the principle of the double antigen-sandwich technique. During testing, a Whole Blood/Serum/Plasma specimen migrates upward by capillary action. The antibodies to HCV if present in the specimen will bind to the HCV conjugates. The immune complex is then captured on the membrane by the pre-coated recombinant HCV antigens, and a visible colored line will show up in the test line region indicating a positive result. If antibodies to HCV are not present or are present below the detectable level, a colored line will not form in the test line region indicating a negative result.

To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

310

(The picture is for reference only, please refer to the material object.) [For Cassette]

Remove the test cassette from the sealed pouch.

For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well (S) of the test device, then start the timer. See illustration below.

For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood(approximately 35μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.

Wait for colored line(s) to appear. Interpret the test results in 15 minutes. Do not read results after 20 minutes.

[WARNINGS AND PRECAUTIONS]

For in vitro diagnostic use only.

For healthcare professionals and professionals at point of care sites.

Do not use after the expiration date.

Please read all the information in this leaflet before performing the test.

The test cassette/strip should remain in the sealed pouch until use.

All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

The used test cassette/strip should be discarded according to federal, state and local regulations.

[QUALITY CONTROL]

A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

[LIMITATIONS]

The HCV Rapid Test Cassette/Strip is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood.

The results obtained from this test are intended to be an aid in diagnosis only. Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.

A negative test result indicates that antibodies to HCV are either not present or at levels undetectable by the test.

[PERFORMANCE CHARACTERISTICS]

Accuracy

Agreement with Commercial HCV Rapid Test

A side-by-side comparison was conducted using the HCV Rapid Test and commercially available HCV rapid tests. 1035 clinical specimens from three hospitals were evaluated with the HCV Rapid Test and the commercial kit. The specimens were checked with RIBA to confirm the presence of HCV antibody in the specimens. The following results are tabulated from these clinical studies:

Commercial HCV Rapid Test Total
Positive Negative
HEO TECH® Positive 314 0 314
Negative 0 721 721
Total 314 721 1035

The agreement between these two devices is 100% for positive specimens, and 100% for negative specimens. This study demonstrated that the HCV Rapid Test is substantially equivalent to the commercial device.

Agreement with RIBA

300 clinical specimens were evaluated with the HCV Rapid Test and the HCV RIBA kit. The following results are tabulated from these clinical studies:

RIBA Total
Positive Negative
HEO TECH®

Positive

98 0 98

Negative

2 200 202
Total 100 200 300

Product detail pictures:

Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit  (WB/S/P) – HEO detail pictures

Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit  (WB/S/P) – HEO detail pictures

Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit  (WB/S/P) – HEO detail pictures

Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit  (WB/S/P) – HEO detail pictures

Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit  (WB/S/P) – HEO detail pictures


Related Product Guide:

We stay with our company spirit of "Quality, Performance, Innovation and Integrity". We goal to create more value for our clients with our abundant resources, advanced machinery, experienced workers and superb solutions for Leading Manufacturer for Dengue Igg Igm - HCV Rapid Test Cassette/Strip/kit (WB/S/P) – HEO , The product will supply to all over the world, such as: Barbados, Salt Lake City, Pretoria, Now we've been sincerely consider to grant brand agent in different areas and our agents' maximum margin of profit is the most important thing we care about. Welcome all of the friends and customers to join us. We have been ready to share win-win corporation.
  • This company has the idea of "better quality, lower processing costs, prices are more reasonable", so they have competitive product quality and price, that's the main reason we chose to cooperate.
    5 Stars By Amelia from Turkey - 2018.11.28 16:25
    We are long-term partners, there is no disappointment every time, we hope to maintain this friendship later!
    5 Stars By Leona from Bulgaria - 2017.06.25 12:48
    Write your message here and send it to us