GenePro SARS-CoV-2 Test kit is developed to enable high throughput analysis and flexibility in test numbers for a single run. It allows qualitative detection of Orf-1ab gene / E gene simultaneously. Orf-1ab gene has specific sequence from SARS-CoV-2 and E gene is common sequence within coronaviruses. The validity of RT-PCR reaction is confirmed by using RNA templete (SARS-CoV-2) as positive control.
BOSON RAPID SARS CoV-2 Antigen Test Card (Self Test) Manufactured by Xiamen Boson Biotech Co., Ltd.
DHSC - UK Approved - 3rd Phase Approved.
NASAL TEST
CE & ISO Approved
Full Home Test - Self Test Approval for UK and Europe
Test Result in 15 Minutes.
Sensitivity 97.70%
Specificity 99.84%
Accuracy 98.97%
Layperson study statistics
99.84% of non-professionals carried out the test without requiring assistance
99.82% of different types of results were interpreted correctly
Each Test have Unique Identifier Number - Easy to track
Approved By - UK, Germany, France, Spain, Netherlands, Greece, Belgium, Italy, Portugal.
1 Test / Kit
Catalog No.: 1N40C5-2
Kit Components:
1 Rapid SARS-CoV-2
Antigen Test Card (sealed
foil pouch)
1 sterilized swab
1 extraction tube
1 sample extraction buffer
IFU
Tube holder on back of box
Box / Carton Specifications :
1 Test / Kit
Box size - 190*60*15 mm
Carton size - 42*42*33 cm
Carton gross weight - 9.9 kg
250 tests (boxes) / carton
Self-test received notified body approved CE Marking on April 1, 2021
A home test for the rapid qualitative detection of SARS-Cov-2 virus antigen in
anterior nasal swabs from individuals with or without symptoms or other
epidemiological reasons to suspect COVID-19
Performance Characterisitics
Sample tyep: nasal swab Time to result: 15-20 minutes
Sensitivity: 97.70% Specificity: 99.84% Accuracy:98.97%
Layperson study statistics
99.84% of non-professionals carried out the test without requiring assistance
99.82% of different types of results were interpreted correctly.
Specifications
1 Test/kit
Catalog No.: 1N40C5-2
Kit components:
1 Rapid SARS-CoV-2
Antigen Test Card (sealed foil pouch)
1 sterilized swab
1 extraction tube
1 sample extraction buffer
IFU
Tube holder on back of box
Price 6.5 EUR + VAT
We send a POL after receiving the LOI.
We deliver in Europe only.
Only for Hospitals.
More information?
The new VivaDiag SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab,oropharyngeal swab or nasopharyngeal swab specimen. The test is for in vitro diagnostic use only.
Special features:
For nasal or throat swab samples
CE marked
Professional Use Only
High Sensitivity
Short Turnout Time
High Specificity
Test Principle: Colloidal gold
Sample Type: Nasal swab, oropharyngeal swab or nasopharyngeal swab
Sample Volume: 60 L
Test Time: 15 min
The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C).
During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. Theconjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area. If it is a negative sample, there is not a purple-red band appeared in the M and G test area. Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.
SARS-CoV-2 Antigen Rapid Test Cassette 1 pcs/pack, 25pcs/pack
available saliva, nasal, nasopharengeal
Products are in European common list.
High sensitivity and specificity
All documents available to sell in EU
We have tests with multilingual instructions manual. English, Bulgarian, Romanian, Greece, Spanish and Italian.
Available for immediate shipping. Delivery to all European countries in 4-10 days.
FlowFlex Sars-CoV-2 Antigen Rapid Test Self Test - Single Pack
The Flowflex SARS-CoV-2 Antigen Rapid Lateral FlowTest is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection by their healthcare provider within the first seven days of the onset of symptoms.
Supplied in a single pack
Cassette Format
Detects the nucleocapsid protein antigen from SARS-CoV-2
Nasal Specimen sample. Anterior Nares Only Test (2-4cm inside the nostril)
Results in 15 minutes
CE Marked for Self Test
Used by NHS track and trace as home test
Unique ID QR code number on each cassette
Pack Contents
1 x Test Cassette with QR code and unique ID number
1 x Extraction Buffer Tube
1 x Disposable Swab
1 x Waste Bag
1 x Package Insert
Features:
Fully Home Use Approved
FDA Approved
Validation from Public Health England Porton Down.
Full Home Test Approval Granted in the UK & EU
Registered with MHRA and CE Marked.
Used and trusted by companies around the world including all UK airports and the NHS.
Product Details:
Number of Reactions(Preps)/Kit : 25
Brand : Roche
ICMR Approved : Yes
Test Method : Antigen Test
Result Time (Rapid Kits) : 10-15 mins
Cat. No : 9901-NCOV-01G
Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2
The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx.
This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment
Cat. No : 9901-NCOV-01G. Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2
The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx.
This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment.
SARS-CoV-2 IgG/IgM Rapid Test Kit
Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma
Product Format:Â 25 tests/kit
Kit Contents: test card, diluent, capillary, lancet, and instruction for use.
Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision
100% Concordant across 3 lots with CV ±5%
Performance Comparison (A)
China Validation Test
Positive Samples 100 / 102
Sensitivity: 98.04%
Negative Samples 491/492
Specificity: 99.80%
Overall Accuracy: 99.49%
Performance Comparison (B)
Positive Samples 23 / 25
Sensitivity: 92%
Negative Samples 25 / 25
Specificity: 100%
Overall Accuracy: 96%
SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal swab samples)
SARS-CoV-2 Antigen Rapid Test Saliva)
We have two fast screening reagents for routine detection. One is the antibody iggigm detection reagent (that is, blood for three minutes) One is antigen rapid screening test reagent (the same is three minutes can use nasal mucosa, oral mucosa, and saliva three detection methods) 1.SARS-CoV-2 antigen testing can detect infection earlier than antibody testing 2.SARS-CoV-2 antigen testing can detect SARS-CoV-2 and all mutant virus strains 3.Easy operation and quick results 4.The result is clear. C-line and T-line determines the infection and the result is easy to read 5.The colloidal gold method has stable performance and is not interfered by environmental and experimental conditions 6.Application: for human throat swab , nasal swab and sputum extract Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 20 minutes
5. Cost-efficient
6:Listed on German BfArm ,got approval by PEI
Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.
Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation.
General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision.
Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals.
Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .
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