SARS-CoV-2 Antibody Test Strip
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% |
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.
| 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℃~30℃ in the foil punch, keep away from direct sunlight, moisture and heat. Do not freeze. |
