SARS-CoV-2/Flu A+B Rapid Antigen Test

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Internal Quality Control: Each SARS-CoV-2/Flu A+B Rapid Antigen Test device has built-in controls. The Control line at the C position can be considered as an internal positive procedural control; i.e a proper amount of sample was used, sample was properly added to the Extraction Well, sample migrated properly and the reagent system worked properly.

A distinct reddish-purple Control line should always appear if the test has been performed correctly. If the Control line does not appear, the test result is invalid and a new test should be performed.

External Quality Control: It is recommended that external control testing be performed by each new operator and before using a new lot or shipment of SARS-CoV-2/Flu A+B Rapid Antigen Test to confirm the expected test performance, using the external controls provided in the kit. The frequency of additional Q.C test should be determined according to your laboratory’s standard Q.C procedures and local, state and federal regulations or accreditation requirements. Upon confirmation of the expected results, the kits is ready for use with patient specimens. If external controls do not perform as expected, do not use the test results.

25pcs per Box

 

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Specifications

  •  For use under the Emergency Use Authorization (EUA) only.
  • For in vitro diagnostic use.
  • Rx only.
  • Refer to the Package insert for the complete instructions. Read the complete test procedure, inlcuding recommended Quality Control procedures, before performing the test.
  • All clinical specimens must be at room temperature ranges provided may produce invalid results.
  • Performing the assay outside the time and temperature ranges must be repeated.
  • Expiration date: Check expiration on each individual test package or outer box before using. Do not use any test past the expiration date on the label.
  • Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between test) for symptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing. Consistent with serial testing recommendations for SARS-CoV-2 for multi-analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection.

 

  

For Research Use only. Not for use in diagnostic procedure. 

Kit Components: 

SARS-CoV-2/Flu A+B Rapid Antigen Test Kit

Applications:

SARS-CoV-2/Flu A+B Rapid Antigen Test is intended for use by medical professionals and laboratory

Storage:
Store all components at -20°C upon receipt.

 

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