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Point of Care Testing

SARS-CoV-2 Antibody Test Strip

Overview

Sinocare SARS-CoV-2 Antibody Test Strip is a rapid, accurate and simple point-of-care IgM-IgG combined antibody test kit, using lateral flow immunoassays, which can qualitatively detect IgM and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15-20 minutes. 

(CE marked, FDA is coming soon!)


Incubation period of COVID-19 would be about 0-10 days,IgM can be detected about 7 days after onset,IgG would appear about 10 days after onset.

References:

1. Li Ping, Li Zhiyong, Preliminary study of serum 2019-nCoV IgM and IgG antibodies in the diagnosis of Novel Coronavirus Pneumonia ,Cite as Chin J Lab Med, 2020,43, DOI: 10.3760/cma.j.cn114452-20200302-00155

2. Xu Wanzhou, Li Juan, The diagnostic value of joint detection of serum IgMand IgG antibodies to 2019-nCoV in 2019-nCoV infection, Cite as Chin J Lab Med, 2020,43, DOI: 10.3760/cma.j.cn114452-20200223-00109


Rapid detection  &  Simple operation

The novel virus, now known as SARS-CoV-2 (also known as COVID-19 or 2019-nCoV), a RNA virus of the beta coronavirus family. IgM-IgG combined antibody test is suitable for rapid diagnosis and screening of the large amount of suspected patients and asymptomatic carriers to prevent secondary transmission and assure timely treatment of infections.


Method

RT-PCR Nucleic Acid Test

IgG-IgM Antibody Test

Specimen

Swab

Whole blood /Serum/Plasma

Test time

Over 2-3 hours

Within 15-20 minutes

Operation

Professional

Simple

Detection condition

Specific equipment required

Point-of-care

Detection rate
Prone to false negative
IgM-IgG test above 90%
Transport/Storage
Requires cold-chain
Room temperature


Accurate results

1.Clinical Evaluation

Total test on 320 subjects, include 240 excluded patients, 60 confirmed patients and 20 cured patients.

Sample type

Sensitivity

Specificity

Serum/Plasma

96.3%

99.6%

Whole blood

95.0%

99.2%

2. Precision


Repeatability

Intermediate Precision

Negative reference coincidence rate (-/-)

100%100%

Positive reference coincidence rate+/+

100%100%


Convenient procedure & Visual result


FAQ

1. What is SARS-CoV-2 & COVID-19?

The novel virus, now known as SARS-CoV-2 (also known as 2019-nCoV before), is a RNA virus of the b novel coronavirus strain, in charge of the current global pandemic. SARS-CoV-2 causes the disease named COVID-19.


2. What is Sinocare SARS-CoV-2 test strip?
It is the IgM-IgG combined test strip, is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.


3. Should I do the SARS-CoV-2 test?

It can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic.


4. How fast is Sinocare’s SARS-CoV-2 test?

Only needs 15-20 minutes.


5. What do the results tell me?

(1) Negative Result: If only the quality control line (C) appears and the detection lines is not visible, then no novel coronavirus antibody has been detected and the result is negative.

(2) Positive Result: Two red lines appear. One line should be in the control zone (C) and another line should be in the test zone (T) shows the result is positive for both the IgG and IgM antibodies.

(3) Invalid: Control line fails to appear (See picture 2). Test result is invalid.


6. If I need a lot, can you meet my demand? 

Yes, we can anlarge our scale production to meet your demands, please confirm your order in advance and our turnaround time is about 1 week.




Specification
Specification

Product

SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method)

Specimen

Whole blood /Serum/Plasma

Sample volume

1 drop(10μl)  of whole blood/ serum/ plasma 

Test time

15-20minutes

Package

25 strips/box; 5 strips/box

Storage condition

Store at 4~30in the foil punch, keep away from direct sunlight, moisture and heat. Do not freeze.



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