Goldsite SARS-CoV-2 Antigen Kit (Colloidal Gold)
Packing:1 test/box, 5 tests/box, 25 tests/box
Use: For qualitative detection of SARS-CoV-2 nucleocapsid antigen to aid in the rapid diagnosis of SARS-CoV-2 infections
Kit components: Test cartridge, Sterilized swab Extraction tube (prefilled with buffer),
Instructions for Use
Time to results: 12 mins
Cert: CE 1434
Made in China
This kit is used to qualitatively detect the novel coronaviruses (SARS-CoV-2) antigen in human nasal throat swabs, oral throat swabs, posterior oropharyngeal saliva, sputum and stool samples.
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.
The current test kit is based on specific antibody antigen reaction and immunoassay technique. The test card contains a gold labeled novel
coronavirus N protein monoclonal antibody p re coated on the binding pad
and a paired novel coronavirus N protein monoclonal antibodies fixed in the
test line (T) and corresponding antibodies in the quality control line (C).
During the test, the N protein in the specimen binds to the gold-labeled nove lcoronavirus N protein antibody pre-coated on the binding pad, and the
conjugate moves upward under the capillary effect, and then is trapped by N
protein monoclonal antibody conjugate fixed in the Test Line (T). The higher
the N protein content in the specimen, the more conjugates are trapped, and
the darker the color of the Test Line (T). If there is no novel coronavirus in
the specimen or the virus content is below the detection limit, no colour
appears in the Test Line (T). A purple red band will app ear in the Control
Line (C) regardless of whether there is a virus in the specimen. The
purple red band that appears in the Control Line (C) is the criteria for
determining whether there is enough specimen and whether the
chromatography process is normal.
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
This kit is used for the qualitative detection of specific antigen against novel coronavirus (SARS-CoV-2) in human specimens (Nasal swabs, oropharyngeal swabs, lower respiratory tract samples).
Principle
This kit adopts colloidal gold-based flow-through, lateral-flow immunoassay and capture method to detect specific antigen against coronavirus in human specimens(Nasal swabs, oropharyngeal swabs.
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%.
SARS-CoV-2 Antigen Detection Kit
For Nasal Swab, home testing
Colloidal Gold Method
Package Available: 1 Test/box, 5 Tests/box, 10 Tests/box, 20 Tests/box
Carton Size: 63 x 39 x39cm
Price is different based on QTY from 10K to 500K or above
Payment Term: T/T
Delivery time: 3-5 days
Price Valid: 30 days
Quality Warranty: 2 years.
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 .
Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)
Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) is used for in vitro qualitative
detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs, oropharyngeal swabs
and nasal swabs from individuals who are suspected of SARS-CoV-2 by their healthcare
provider within the first seven days of symptom onset.
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
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
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
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)
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.
