SARS-CoV-2 Antibody Test - Bilcare Research Antibody Test (Lateral Flow Me… · SARS-CoV-2...
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SARS-CoV-2 Antibody Test (Lateral Flow Method) GUANGZHOU WONDFO BIOTECH CO., LTD. CFDA CE The 1 st officially approved antibody test in China! Easy to use, no equipment required Multiple sample types, including fingerstick blood Instant result in 15 minutes Total antibody test, higher detection rate comparing with single IgG/IgM test CFDA and CE certified IgM IgM IgG Antibody concentration Days Infection 0 Days after infection Window period (Around 7 days) Recovering Second infection IgG IgM IgM PCR PCR Total antibodies(≈IgM+IgG) Detection time .......................................................... Application • Antibodies usually become detectable in the human blood 7 days later after disease onset, detection rate is higher after 10 days since disease onset. • RT-PCR test should be comfirmed in case of false positive/negative of antibody detection. • Because of high false-negative rate of RT-PCR test， antibody test is recommended for re-confirmation. • Suspected patients can be excluded from COVID-19 if two negative results for two consecutive RT-PCR tests of respiratory tract samples taken at least 24 hours apart and negative result for antibody test performed 7 days after disease onset. Suspected case screening Help the exclusion of non-COVID-19 patients RT-PCR negative patients re-confirmation Identify asymptomatic patients Epidemiological tracing Suspected Patients SARS-CoV-2 Real-Time RT-PCR Test Wondfo SARS-CoV-2 Antibody Test
Transcript of SARS-CoV-2 Antibody Test - Bilcare Research Antibody Test (Lateral Flow Me… · SARS-CoV-2...
SARS-CoV-2 Antibody Test(Lateral Flow Method)
GUANGZHOU WONDFO BIOTECH CO., LTD.
CFDA CE
The 1st officially approved antibody test in China!
Easy to use, no equipment required
Multiple sample types, including fingerstick blood
Instant result in 15 minutes
Total antibody test, higher detection rate comparing
with single IgG/IgM test
CFDA and CE certified
1
IgM
IgM
IgG
Ant
ibod
y co
ncen
trat
ion
DaysInfection
0
Days after infection
Windowperiod(Around7 days)
Recovering Second infection
IgG IgM IgM
PCR PCR
Total antibodies(≈IgM+IgG)
Detection time
..........................................................
Application
• Antibodies usually become detectable in the human blood 7 days later after disease onset, detection rate is higher after 10 days since disease onset.
• RT-PCR test should be comfirmed in case of false positive/negative of antibody detection.• Because of high false-negative rate of RT-PCR test， antibody test is recommended for re-confirmation.• Suspected patients can be excluded from COVID-19 if two negative results for two consecutive RT-PCR
tests of respiratory tract samples taken at least 24 hours apart and negative result for antibody testperformed 7 days after disease onset.
Suspected case screening
Help the exclusion of non-COVID-19
patients
RT-PCR negative patients re-confirmation
Identify asymptomatic patients
Epidemiological tracing
Suspected Patients
SARS-CoV-2Real-Time RT-PCR Test
Wondfo SARS-CoV-2Antibody Test
Operation procedure
Performance
Sensitivity: 86.43% (95%CI: 82.51%~89.58%)Specificity: 99.57% (95%CI: 97.63%~99.92%)Total consistent: 91.61% (95%CI: 89.10%~93.58%)
Order information
Product nameCatalog No. Packing size Sample type Storage condition Shelf life
SARS-CoV-2 Antibody Test
(Lateral Flow Method)
W195 20T Fingerstick blood, venous whole blood
plasma, serum
2~30℃ 12 months CFDA, CE
Qualification
Fingerstick
Whole Blood
Venous Whole
Blood/Serum/Plasma
10 μL
nCoV nCoV nCoVnCoV nCoV nCoVnCoV nCoV nCoV
CT
SARS-C
oV-2
nCoV nCoV nCoVnCoV nCoV nCoVnCoV nCoV nCoV
CT
2~3 Drops
SARS-C
oV-2
15 minutes
Control line
IgG+IgM line
Positive Negative Invalid
01.
03.
02.
04.
Reagents
Wondfo SARS-CoV-2Antibody Test(Laberal Flow Method)
Positive
Negative
312
49
361
1
234
235
313
283
596
Clinical cases
Confirmedcase samples
Excludedcase samples
Total
Total
Add: No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China
Tel: +86-20-32296083 Fax: +86-20-32296063 E-mail: [email protected] Websites: en.wondfo.com.cn
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