Immune Colloid Gold Asssays

One Step COVID-19 IgG/IgM Rapid Diagnostic Tests

Expanded diagnostic coverage from acute to convalescent phase of COVID-19 

Wholepower® COVID-19 IgG/IgM Rapid Diagnostic Test can be used for rapid screening of carriers of the virus that are symptomatic or asymptotic. The study shows the certain high percentage of patients show no clinical symptoms of the virus; thus screening patients is vitally important. Our tests should be ideally and widely used in hospitals, clinics and test laboratories. More important, early diagnostic and screening diagnostic for the group of people can significantly reduce the cost of PCR tests, and making the PCR tests are the confirmation tests only and make the CDC knows the spreading of the virus as early as possible by the fast, cost effective and convenient method. So the tests must be effectively deployed in business, schools, airports, seaports, and train stations, etc...

Principles

Wholepower® COVID-19 IgG/IgM Rapid Diagnostic Test is a colloid gold enhanced capture immunoassay for qualitative determination of COVID-19 IgG and IgM antibody in human serum, plasma and whole blood sample. The products is pre-embeded with recombined COVID-19 antigen and chicken IgY antibody on the nitrocellulose membrane, and coated with anti-human IgM, anti-human IgG and goat anti-chicken IgY antibody respectively on the G line, M line and C line on the nitrocellulose membrane. When a positive samples tested, the COVID-19 IgM and / or IgG antibody combine with the colloid gold labeled COVID-19 antigen to form a complex. Under the action of chromatography, the complex flows along the membrane, when it passes G line and / or M line it combines with the anti-human IgM and / or IgG to forma colloid labeled chicken IgY antibody combined with goat anti chicken IgY antibody at C line to show color. Negative samples only show color on C line. 

Specifications

Specimen

Serum / Plasma / Whole Blood

Time to Result

10 - 15 Minutes

Shelf Life

24 Months

Catalogue #

2700320

Packing 

20 Tests / Box

20 Boxes / Carton

Certificates List

Producer Certificates

ISO13485:2016

White List issued by Chinese Government

Products Certificates

CE Certificates issued by Qarad B.V

Belgium Government Registration of the products

Clinical Report

MDMS

Brochure

Buffer Air Transportation Safety Report

Risk Management Report

Transportation Stability Study Report

... ...

User Instruction

User Instruction

IFU.PDF

Vedio.mp4

Video of Test Procedure
1/5

OEM SERVICE

Rapid Diagnostic Tests OEM service

RT-PCR OEM Service

GLOBAL DISTRIBUTION

UK Sales Office

USA Sales Office

TECHNICAL TRANSFER

Semi-finished products 

Local Assembling

DOWNLOAD FILES

Catalogue(s)

Instruction(s)

Brochure(s)

General Sales Terms

RELATED WEBSITES

USPTO

WHO

US FDA

About Us   I     Contact Us   I     Disclaimer    I     On-Line Purchase    I     Tech Support

粤 ICP备 20063115号 © 2020 Whoelpower Biotech Co.,Ltd. All rights reserved.