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Rapid Sars-Cov-2 Antigen Test Card

(1.1)
Supplier From China
Nov-26-21

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

Price and Minimum Quantity

Price: $1.15
MOQ: Not Specified
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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
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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.

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Kit Components:
1 Rapid SARS-CoV-2
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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
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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
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Test Kit Specifications:
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Everything needed to run a test with materials provided in each kit:

20 Rapid SARS-CoV-2 Antigen Test Cards
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Product Information:
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Sample type: Nasopharyngeal swab
Storage temperature: 2-30 C
Shelf life: 18 months
Test time: 15-20 minutes

Intended Use:
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Product Information:
Quantity: 20 tests/kit
Sample type: Nasopharyngeal swab
Storage temperature: 2-30°C
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Kit Contains:
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20 Sterilized swabs (Individually packaged)
20 Extraction tubes (Individually packaged)
1 Instructions for use
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For in vitro qualitative detect of Covid-19 antigen in nasal(NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of the symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.

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