COVID 19

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by infection with the SARS-CoV-2 virus, a new strain of coronavirus that was first identified during 2019-2020 pandemic

7,000,000

Delivered serology tests (July 17,2020)

Along with the spreading global pandemic of Novel Coronavirus, countries around the world have been struggling to diagnose and control this disease in time. Xiamen University and Wantai have jointly developed a series of innovative, highly sensitive and specific serological and molecular assays for testing of Covid-19. Together our tests offer total testing solution for Covid-19 diagnosis with results available in just 75-minutes. Download Wantai COVID-19 Diagnostics Test Introduction Brochure.

Wantai SARS-CoV-2 Diagnostic Kits:

SARS-CoV-2 Total Ab ELISA

SARS-CoV-2 Total Ab ELISA   Download Brochure

WANTAI SARS-CoV-2 Ab ELISA detects total antibody as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of seroconversion in patients following known recent SARS-CoV-2 infection. The test may also be used to aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information. The prevalence of SARS-CoV-2 infection in the area where testing has occurred should be considered when interpreting positive test results. The test should not be used as the sole basis for diagnosis.

Performance evaluations (click on the links to open each study report)

The kit detects TOTAL ANTIBODIES (IgG, IgM and IgA) against S1-RBD and it has been extensively evaluated and validated in Europe.

In the Netherlands, reporting by the Dutch Serology Taskforces shows sensitivity of the kit of 98.1%  for samples collected > 14 days after onset of illness, the Dutch Serology Taskforce report can be downloaded from HERE. In other studies conducted in the Netherlands, Erasmus Medical Center showed sensitivity of 98% (100% >14days) and Sanquin Blood Bank calculated PPV of 99%, 88%, and 72% in areas with prevalence of 4-10%, 2-4%, and <2%. .

Statens Serum Institut in Denmark showed sensitivity of 71% (7~13days) ~ 100% (10days) . Also in Denmark, multicentre comparison study ranked Wantai SARS-CoV-2 Ab ELISA as the top serology assay among 15 commercially evaluated tests including automated immunoassays.  The Medizinische Universität Wien in Austria calculated sensitivity of 92~100% , and in France, the French National Reference Center (CNR) evaluated the kit and concluded that it has sensitivity of 100% (7-13days), 95% (14-19days) and 98% (>20days) respectively. Over 98% agreement with automated immunoassays has been demonstrated during a study conducted by the University Hospital in Padova, Italy.  In Belgium, AZ Delta Medical Laboratories and Ghent University concluded that Wantai SARS-COV-2 Ab ELISA is suitable for sensitive and specific screening of a SARS-CoV-2 infection from 10 days after symptom onset. ICMR/NIV in India evaluated the kit, the sensitivity was 98% and the specificity was 100%.

In the United States, validation study conducted by the National Cancer Institute (NCI) showed sensitivity of 96.7% (29/30) and specificity of 97.5% (78/80) of the test. Subsequently, WANTAI SARS-CoV-2 Ab ELISA received FDA Emergency Use Authorization on August.05,2020. Downloads: Letter of Authorization , HCP , Recipients , IFU , NCI Report.

FIND results are expected soon.

SARS-CoV-2 lgM ELISA

SARS-CoV-2 lgM ELISA    Download Brochure

Wantai SARS-CoV-2 lgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of lgM-class antibodies to SARS-CoV-19 virus in human serum or plasma. It is intended for testing of patients suspected of recent infection with the SARS-CoV-2 virus. The test should not be used as the sole basis for diagnosis. The test is based on antibody-capture method.

Performance evaluations (click on the links to open each study report)

The Medizinische Universität Wien in Austria reported sensitivity of 92% (6 ~10days) to 100% after day 11 post disease onset, and 97% specificity of the kit. In the Netherlands, data collection and reporting by the Serology Taskforce, which is part of the Dutch National Testing Capacity Coordination Structure  shows sensitivity of the kit of 91.9% for samples collected > 14 days after onset of illness. The  Dutch Serology Taskforce report can be downloaded from HERE.

FIND results are expected soon.

SARS-CoV-2 Total Ab Rapid Test

Rapid Test for Total Antibody to SARS-CoV-2    Click to Download Brochure

! IMPORTANT : THIS PRODUCT IS INTENDED FOR PROFESSIONAL USE ONLY, NOT FOR SELF-TESTING OR TESTING AT HOME !

WANTAI SARS-CoV-2 Ab Rapid Test is a 15minutes test that detects total antibody as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of seroconversion in patients following known recent SARS-CoV-2 infection. The kit is based on double antigen "sandwich" method and it detects TOTAL ANTIBODIES against S1-RBD. The test may also be used to aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information. The prevalence of SARS-CoV-2 infection in the area where testing has occurred should be considered when interpreting positive test results. The test should not be used as the sole basis for diagnosis.

Performance evaluations (click on the links to open each study report) :

In a limited validations, the RIVM National Institute for Public Health in the Netherlands, and the Ministry of Health in the Czech Republic both reported sensitivity and specificity of 100%. In Austria, the Medizinische Universität Wien calculated sensitivity of 80% (6-10days) and 100% (>11days) respectively, and the University of Innsbruck reported sensitivity of 95.7% (100% >14days) and specificity of 100%. In France, the French National Reference Center (CNR) evaluated the kit and conclude that it has sensitivity of 89% (7-13days), 92% (14-19days) and 94% (>20days) respectively.

In the United States, validation study conducted by the National Cancer Institute (NCI) showed sensitivity of 100% (30/30) and specificity of 98.8% (79/80) of the test. Subsequently, WANTAI SARS-CoV-2 Ab Rapid Test received FDA Emergency Use Authorization on July.10,2020.  Downloads: Letter of Authorization , HCP , Recipients , IFU , NCI Report.

FIND and Doherty Institute evaluation results are expected soon.

View our how to operate video.


SARS-CoV-2 Ag Rapid Test

Rapid Test for SARS-CoV-2  Antigen (FIA)

! IMPORTANT : THIS PRODUCT IS INTENDED FOR PROFESSIONAL USE ONLY, NOT FOR SELF-TESTING OR TESTING AT HOME !

WANTAI SARS-COV-2 Antigen Rapid Test is a lateral flow immunofluorescent assay (FIA) intended for qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal (NP) and nasal (NS) swab specimens after the swabs have been collected into viral transport media (VTM).

Specifications:

-  target:  nucleocapsid antigen
-  specimens: nasopharyngeal (NP) and nasal (NS) swab specimens after
-  time to results: 20min.
-  instrument:  FS-100 fluorescence spectrometer

Performance  :

-  patients with RT-PCR Ct≤30, sensitivity 93%, specificity 100%
-  patients with RT-PCR Ct≤35, sensitivity 83%, specificity 100%
-  patients within 7 days of symptoms onset,  sensitivity 81%
-  patients after 7 days of symptoms onset,  sensitivity 30%
-  LoD of 5pg/mL

SARS-CoV-2 RT-PCR

SARS-CoV-2  RT-PCR  Download Brochure 

Wantai SARS-CoV-2  RT-PCR Kit is a Nucleic Acid Detection kit for the detection of Severe Acute Respiratory Syndrome Coronavirus (PCR – Fluorescence Probing).

This kit is intended for detection of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 ) RNA extracted from oropharyngeal swab, nasopharyngeal swab, sputum, endotracheal aspirate and bronchoalveolar lavage fluid samples of patients suspected for infection with COVID-19.

Wantai SARS-CoV-2  RT-PCR  is a qualitative, real-time fluorescent PCR in which specific primers and fluorescent probes are designed to detect the highly conservative regions of the ORF1ab and N genes of the virus. This kit has integrated quality control (IC, human housekeeping gene) intended for monitoring of the test run.

LoD: 50 copies/ml

Ct cut-off: ≤40

Clinical sensitivity (50 positives):  100% (95%CI: 93 ~ 100)

Clinical specificity (100 negatives):  100%(95%CI: 96 ~ 100)

FIND evaluation results are available here.


SARS-COV-2 PCR Extraction Kit

Nucleic Acid Extraction Kit (magnetic beads method)

Nucleic Acid Extraction Kit for isolating viral DNA and RNA using superparamagnetic beads, the extracted nucleic acid is applicable for molecular detection such as PCR and real time-PCR.  High purity viral nucleic acid can be extracted from human nasopharyngeal swabs, sputum, broncho lavage and alveolar lavage fluid samples.

-  Purity (A260/A280) : DNA 1.8 ~ 1.9 ; RNA 1.9 ~ 2.0

-  Extraction Efficiency : >95%

Recommended Extraction Instrument : NEXOR 32 


SARS-COV-2 VTM  (Nucleic Acid Releaser)

Viral Transport Media - transportation and storage tube with virus lysis buffer.

Clinical specimens collected with nasopharyngeal and oropharyngeal swabs can be dissolved into this product for later testing or storage. This product contains appropriate concentrations of guanidine isothiocyanate and other components for cellular lysis to effectively suppress the activity of DNase/RNase in specimens, which contributes to the stable storage of the specimen’s nucleic acid without affecting its extraction/purification and amplification tests.

Authorized Distributors

DISTRIBUTORS

Nordic countries: Nordic Biosite

Telephone: +46(0)8-54443340

info@nordicbiosite.com

www.nordicbiosite.com


Austria & Switzerland: SZABO-SCANDIC

Telephone: +43-1-489 3961-0

mail@szabo-scandic.com

www.szabo-scandic.com


Benelux: Sanbio B.V.

Telephone: +31 413 251115

orders@sanbio.nl

www.sanbio.com


Germany: Sanbio B.V.

Sanbio B.V.

Telephone: +31 413 251115

orders@sanbio.nl

www.sanbio.com

Germany: Human Diagnostica

Telephone: +49 6122 9988-0

info@human.de

www.human.de


Iberia: Quilaban

Telephone: +351 21 923 63 50

quilaban@quilaban.pt

www.quilaban.pt


France: Eurobio Scientific

Telephone: +33 1 69 79 18 26

supplychain@diaxonhit.com

www.eurobio-scientific.com


Italy: D.B.A. ITALIA s.r.l.

Telephone: 02 2692 2300

orders@dbaitalia.it

www.dbaitalia.it


Balkans, Africa and South America (non exclusive): Human Diagnostica

Telephone: +49 6122 9988-0

info@human.de

www.human.de


The Balkans (PCR only) : Interactive d.o.o.

Telephone: +385 91 5500 900

eu.interactive@gmail.com


Czech & Slovak: Testline (ELISA)

Telephone: +420 549 121 239

sales@testlinecd.com

www.testlinecd.com

Czech & Slovak: Kommand Team s.r.o. (Rapid Test)

Telephone: +420776606860

kommand2010@atlas.cz


Russia & CIS: Cosmopharm LLC

Telephone: +7 (495) 644 00 31

office@cosmopharm.ru

www.cosmopharm.ru

www.covidlabtest.ru


UK & Ireland: Cambridge Bioscience

Telephone: +44( 0) 1223 316 855

salesl@bioscience.co.uk

www.bioscience.co.uk


Australia & New Zealand: Suretest

Telephone: +61449994615

app@surecell.com

www.suretest.com.au


USA: Dynex Technologies

Telephone: +1  703.631.7800

customerservice@dynextechnologies.com

www.dynex.com


Mexico, Venezuela, Colombia : Laboratorios DAI

Telephone: +57 1 2122744 (Colombia, Venezuela)

Telephone: +52 (55) 2624-2500 (Mexico)

jolivera@labdai.com

www.labdai.com


Ecuaodor : Vibag C.A.

Telephone: +593 4288407 Ext. 113

kavendano@vibag.com.ec

www.vibag.com.ec


Chile : 

Vytrous

Telephone: +56 9 65183943

yumi.ikei@vytrous.com

www.vytrous.com

Biocant

Telephone: +56 226830900

cristian.zamora@biocant.cl

www.biocant.cl


The Philippines:  Caffrey Trading Co.

Telephone: 0956-188-8873 /  0951-336-9656

medical.querries@caffrey.ph


Thailand : Hippo Marketing

Telephone: +66 66-164-9199

natkrita.lip@hippomarketing.co.th

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