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.
CLINICAL PERFORMANCE
SARS-CoV-2 Antigen Test Kit
Comparator Method (NTA)
Positive Negative Total
Positive 97 0 97
Negative 3 100 103
Total 100 100 200
- Positive Agreement (95% CI): 97/100 97% (83.3% - 99.9%)
- Negative Agreement (95% CI): 100/100 100.0% (95.5% - 100%)
- 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
We can supply SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Imunoassay), to anywhere in the world, for more details please visit our
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.
Test Kit for self test 1 test/ 5 tests/ 20 test per kit
Test Kit for professional use 1 test/ 5 tests/ 20 test per kit
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 5 Tests/Kit Catalog No.: 1N40C5-4 Kit components: 5 Rapid SARS-Cov-2 Antigen Test Card (sealed foil pouch) 5 Sterilized swabs 5 extraction tubes 5 sample extraction buffer IFU 1 tube stand 20 Tests/Kit Catalog No.: 1N40C5-6 Kit components: 20 Rapid SARS-Cov-2 Antigen Test Card (sealed foil pouch) 20 Sterilized swabs 20 extraction tubes 20 sample extraction buffer IFU 1 tube stand
Key information of the specs for the Boson SARS-CoV-2 antigen self-tests that we distribute in Europe. For test kits in single-pack, we can offer the following terms from our OTG stock in Tananger, Norway: Product SARS-CoV-2 Rapid antigen test card (nasal) Brand Boson Biotech Pcs/box 250 tests Pcs/ctn 1 test Catalogue no. 1N40C5-2 Quantity 50'000 - 600000 tests Price/test EURO 0,61
RAPID SARS-CoV-2 antigen test card
BOSON - Rapid SARS-CoV-2 Antigen Test - Pack of 5 Available at 0.75 EUR Plus VAT and Transport per test IFU - Swedish, Finissh, Norwagian, English, Danish Product Descirption : "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 Characteristics: Sample type: nasal swab Time to result: 15-20 min Sensitivity - 97.70% Specificity - 99.84% Accuracy - 98.97% UK MHRA - DHSC Approved for Self Test Approved in Germany, France, Italy, Belgium, Netherlands, Greece, Spain, Portugal. 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 Test Kit Specifications: 5 Tests / Kit Catalog No.: 1N40C5-4 Kit Components: 5 Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 5 sterilized swabs 5 extraction tubes 5 sample extraction buffer IFU 1 tube stand Box / Carton Specifications : 5 Tests / Kit Box size - 202*60*37 mm Carton size - 42*42*33 cm Carton gross weight: 10 kg 500 tests (100 boxes) / carton" MOQ : 3000 FOB Price : Euro 1.03
Test Kit for self test (nasal swab) 1 test/ 5 tests/ 20 test per kit
