Antigen Fastep Rapid Diagnostic Test Kit High Accuracy CE Europe Approval
Oropharyngeal Swab Specimen Collection:
Insert swab into the posterior pharynx and tonsillar areas.Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue,teeth,and gums.
Specimen Transport and Storge:
Do not retum the swab to the original swab packaging.Freshly collected specimens should be processed as soon as possible,but no later than one hour after specimen collection.Specimen collected may be stored at 2-8℃ for no more than 24 hours;store at-70℃ for a long time ,but avoid repeated freeze-thaw cycles.
Testing Procedure:
1, Peel off the aluminum foil seal from a sample extraction tube.
2, Immerse the sampled swab into the sample extraction tube to make the sample extraction buffer completely penetrate the swab,rotate and squeeze the swab 5 times,take out and discard the swab.
3, Insert the tube cap firmly on the sample extraction tube.Gently shake the extraction tube for about 5 seconds to make sure sample mix well with eatraction buffer.
4, Transfer 2-3 drops of mixed sample into the test card vertically,start the timer.Read the result at 15 minutes.Don’t interpret the result after 20 minutes.
* Read the result at 15 minutes.Result after 20 mins will not be valid.
SPECIMEN COLLECTION AND PREPARATION:
1. Specimen collection:
The swab sample should be collected using the collection tools provided with the kit.Follow the instructions detailed below.No other collection tool should be used with this test.The SWAB collected at any time of the day can be used.
2. Specimen preparation:
When the swab sample is collected,follow the direction to prepare the specimen with buffer provided with the kit.
STORAGE AND STABILITY:
Store The SARS-CoV-2 antigen IVD kit SWAB at room temperature or refrigerated(4-30℃).Do not freeze.All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.
PRODUCT FUNCTION:
The kit is used for qualitative detection of SARS-COV-2 antigen in human nasopharyngeal swab and oropharyngeal swab samples.
APPLICABLE MEDICAL STAGES:
This product can be used for diagnostic screening.
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Antigen Rapid Test Kit High Accuracy CE Europe Approval Images
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