Sars-Cov-2 Antigen Rapid Test

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.

REF - L031-125V5

Format - Cassette 3.5 mm

Finished or Bulk - Finished in kit box

Kit Size - 5

Carton Size - 600 pouches (120kits)

Carton Size (mm) - 520*395*440

Gross weight per carton (kg) - 10.55

quantity per carton - 600

Carton # - 1,666.67

Order quantity (pcs) - 1,000,000

Order gross weight (kg) - 17583

Order total volume (cbm) - 150.627

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%.

Sensitivity: 95.06% Specificity: 99.62%

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 .

The FlowFlex Rapid Antigen Test uses the latest patented technology to detect proteins in nasal samples, ensuring that it can detect all strains of the COVID-19 virus within just 15 minutes. Using a simple nasal swab with 2cm of the nose - it makes it extremely easy to personally administer an accurate lateral flow test without medical supervision.

Each individually packaged kit comes complete with:

1 x Test Cassette
1 x Extraction Buffer Tube with Reagent
1 x Disposable Swab
1 x Waste Bag
1 x Package Insert

Performance Efficacy:
Relative Sensitivity: 97.1% (83.8%-99.9%)*
Relative Specificity: 99.6% (97.7%-99.9%)*
Accuracy: 99.3% (97.5%-99.9%)*
*95% Confidence Intervals

PocRoc SARS-CoV-2 Antigen Rapid Test Kit (TRFIA) is intended for qualitative
detection of SARS-CoV-2 nucleocapsid antigen from NS specimen or VTM sample
without guanidine

-Target: nucleocapsid antigen
-Specimens: Nasal Swab (NS) /Oropharynge al Swab(OP) Virus Transport Medium (VTM)
- Time: Specimen lysis time: 1min; Detection Time: 15min
-Instrument: LTRIC-300,LTRIC-600,UV Flashlight
-Shelf Time: 18months
-LoD: Estimated 25 TCID50/Swab

The lab indicated that the recombinant protein of Indian mutant (B.1.617.2),
A.23.1(Unit Kingdom), AT.1 (Russia), B.1.1.7(Unit Kingdom), B.1.351 (South Africa),
B.1.616 (France), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil),
P.2 (Brazil) can be detected by Jinwofu SARS-CoV-2 Antigen Test Kit.
For the newly descovered mutant Omicron(B.1.1.529), we performed sequence
alignment analysis on its mutation sites, and found that all the mutation sites were
outside the epitope region recognized by the monoclonal antibody selected by our company.
By bioinformatics analysis, Jinwofu SARS-CoV-2 Antigen Test Kit can also effectively detect
mutant Omicron(B.1.1529)

The kit is used to qualitatively detect the novel coronavirus (SARS-CoV-2) nucleocapsid protein antigen in human nasal swab samples in vitro. In the acute phase of infection, antigens are usually detectable in upper respiratory tract specimens.