OEM Customized Rapid Test Device Detection Of China New Corona Virus - One Step SARS-CoV2(COVID-19)IgG/IgM  Test – TESTSEA

☆ A Much Easier and Faster Way to Diagnose COVID-19

Sero/oqv test such as immunochromatography rapid test is highly recommended in combination use of nucleic acid test in COVID-19 because:

1. The COVID-19 coronavirus misdiagnosis is a huge concern due to many reasons and more likely happens if only rely on single PCR test result.

2. The PCR/molecular tests require much higher standard and facilities to perform from both safety and quality perspectives. It becomes the major bottleneck to test suspected cases (can be large in some countries) in time. Shortage of test performed will lead to potential mass infection events in terms of COVID-19.

3. Serology test may also function as markers for prognosis, virus tracing and epidemiology study.

Diagnostic Kit for IgM/IgG Antibody to Novel Coronavirus (Colloidal Gold)

Diagnostic Kit for IgM/IgG Antibody to Novel Coronavirus (Colloidal Gold)

☆ IgM & IgG tests as lab confirmation method newly adopted in China from March

Serology tests have been adopted as one of the lab confirmation tests (molecular PCR, sequencing and serology) of COVID-19, published on the Guideline for COVID-19 Diagnosis and Treatment, 7th Editionby the National Health Commission of RR.China dated March 3rd, 2020. “Seroconversion of COVID-19 specific IgM antibodies usually can be detected in 3-5 days after symptoms”

Tonfirm suspected infection cases when:

1. COVID-19 specific IgM AND IgG antibody together show positive in serum; or
2. COVID-19 specific IgG antibody seroconverts or 4 times higher titer changes measured.“

☆ Performance Studies Overview

1. Specificity Study:

a. a.Internal enterprise controls including negatives and cross-reaction samples (other frequent respiratory infectious disease patients’ serum)
b. Official sampling validation performed by National Institutes for Food and Drug Control (China) and achieved PASS“
2. Sensitivity Study:

3. Advanced Confirmed (before positive PCR result) Cases Study:

8 antibody positive cases (symptomatic/asymptomatic) found before PCR confirmation (one even with 11 negative results in a row) then confirmed within days. Such indication is not priority study in China therefore no clinical enrollment carried out.

*Research Use Only product information
*Officially approved product inserts shall prevail

☆ ELISA test to COVID-19 IgM and IgG (RUO)

☆ ELISA test to COVID-19 IgM and IgG (RUO)

Economic and Efficient Batch Automation with hundreds of samples More Repeatable Lab Test Quality based on the most established ELISA Quantitative Tests In Research, can be used for:

• Detail study to course of disease and prognosis (e.g. IgG level)
• Assist determination of recovery period and hospital discharge
• Evaluate antibodies from the serum of cured patients for treatment
• All-in-one Lyophilized Kit, super stable in ambient temperature
• Large volume reaction system to ensure high sensitivity
• Optimized extraction system assures high quality result
• Full range mineral oil cover; safe and free of contamination
• Automation equipment for high throughput when shorthanded