Molecular Diagnostic Tests for SARS-CoV-2
Other Tests for SARS-CoV-2
Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
IVDs for Management of COVID-19 Patients
INTENDED USE
For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection.
FEATURES
Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2.
Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva.
Easy to use, easy results interpretation by naked eyes.
Test result available within 15minutes.
TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit.
RESULTS INTERPRETATION
Positive: A red line appears on the test line (T) and the control line (C).
NOTE: A positive result does not rule out co-infections with other pathogens.
Negative: Only the control line (C) appears, and no red line appears on the test line (T).
NOTE: A negative result does not exclude infection.
Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again.
- LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen.
- Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable.
- No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track.
- Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%)
- Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%).
[Product Name]: SARS-CoV-2 Antigen Test
[Product Code]: Cat# FP-318
[Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva
[Detection Method]: Colloidal Gold
[Reaction Time]: Within 15min
[Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1.
[Storage Conditions]: 2*C ~ 30*C
[Shelf Life]: 12 months
[CE Mark Registration No.]: RPS/99/2021.
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
Euro 1.12
17034 Antigen Diagnostic Tests For Sars Cov 2 Suppliers
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This SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) is intended for use by laypeople in the home environment. The application is carried out using saliva as a sample. - Patient-friendly - Saliva as a sample - User-friendly - simple and time-saving thanks to pre-filled sample tubes - Reliable - meets the valid requirements of the RKI and the BfArM and was evaluated by the Paul Ehrlich Institute PEI - Result within 15 minutes - All necessary materials in the pack contain specifications: - Colloidal gold immunoassay - Sensitivity: 95.51% (7 days after onset of symptoms) - Specificity: 99.45% - Sample material: saliva - Pack size: 1 test - Storage: 2 - 30 C - Shelf life: 18 months - Special approval for laypeople by the BfArM (BfArM GZ: 5640-S-032/21) - Specifications positively evaluated by the PEI (Paul-Ehrlich-Institut) Permitted users: Self-test for laypeople Scope of delivery per pack: 5x test cassette packed in foil pouch 5x sample tubes with extraction buffer 5x sterile disposable swabs 1x instructions for use 1x brief instruction
This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.
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
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.
A kit contains:
Package specifications: 25 tests/box
1) Getein SARS-CoV-2 antigen test card in a sealed pouch with desiccant
2) Sample extraction solution: 25 tubes/box
3) Sampling swab: 25 pieces/box
4) Disposable pipette: 25 pieces/box
5) User manual: 1 piece/box
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.
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.
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
