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Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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Single Pack HCV Uncut Sheet Rapid Test Hepatitis C Test Kit

Hangzhou Aichek Medical Technology Co.,Ltd
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Single Pack HCV Uncut Sheet Rapid Test Hepatitis C Test Kit

Brand Name : Aichek

Model Number : HCV-A01

Certification : CE 13485

Place of Origin : China

MOQ : 5000 Test

Price : negotiable

Payment Terms : T/T

Supply Ability : negotiable

Packaging Details : 40box/carton

Storage : 2℃-30℃

Sample Type : Blood

User : Professional

Accuracy : 99.6% (97.7%-99.9%)

Certificate : CE ISO 13485

OEM : OEM customized packing avaliable

Formats : 25T/box 1T/box

After-sales Service : Available

Key words : HCV Rapid Test uncut sheet

For the crowd : Preliminary screening of infected people

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Infection Disease Hepatitis C HCV Rapid uncut sheet

Product Name Infection Disease Hepatitis C HCV Rapid Test Device
Formats Strip(3mm)Device(4mm) uncut sheet
Place of Origen China
Specimen Blood
Read Time 15 minutes
Shelf life 2 years
Package uncut sheet
Storage 2℃-30℃


For professional in vitro diagnostic use only

INTENDED USE

The HCV Rapid Test (Whole Blood /Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HCV in human whole blood, serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HCV infection.

PERFORMANCE CHARACTERISTICS

Table: HCV Rapid Test vs. EIA

Relative Sensitivity: 99.8% (99.0%-100.0%)*

Relative Specificity: 99.9% (99.8%-100.0%)*

Overall Agreement: 99.9% (99.7%-99.9%)*

*95% Confidence Interval

HCV Rapid Test
+ - Total
EIA + 565 2 567
- 1 2543 2544
566 2545 3111

PRINCIPLE

The HCV Rapid Test Strip (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.


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