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
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.
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
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.
