Real-Time Fluorescent RT-PCR COVID-19 Test Kit

GENERAL DESCRIPTION

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is an in vitro diagnostic real-time reverse transcription-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in throat swabs and bronchoalveolar lavage fluid (BALF) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, to perform high complexity tests.

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Real-Time Fluorescent RT-PCR Kit for detecting SARS-2019-nCoV is only for use under the FDA’s Emergency Use Authorization.

PRINCIPAL & PROCEDURE

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test. The SARS-CoV-2 primer and probe set(s) is designed to detect RNA from the SARS-CoV-2 in throat swabs and Broncho alveolar Lavage Fluid (BALF) from patients who meet CDC SARS-CoV-2 clinical criteria (e.g., signs and symptoms associated SARS-CoV-2 infection) in conjunction with CDC SARS-CoV-2 epidemiological criteria (e.g., history of residence in or travel to a geographic region with active SARS-CoV-2 transmission at the time of travel, or other epidemiologic criteria for which SARS-CoV-2 testing may be indicated).

MATERIALS PROVIDEDITEMS (50 Tests / Kit) ]

• SARS-CoV-2 Reaction Mix

 - 1 mL / Vial

 - 1 Vial

• SARS-CoV-2 Enzyme Mix

 - 80 µL / Vial

 - 1 Vial

• SARS-CoV-2 Positive Control

 - 750 µL / Vial

 - 1 Vial

• SARS-CoV-2 No Template Control

 - 750 µL / Vial

 - 1 Vial

WARNINGS & PRECAUTIONS

  • Federal Law restricts this device to sale by or on the order of a licensed practitioner.

  • For emergency use only.

  • For in vitro diagnostic use only (IVD).

  • Follow standard precautions. All patient specimens and positive controls should be considered potentially infectious and handled accordingly.

  • Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and human specimens are handled.

  • Handle all specimens as if infectious using safe laboratory procedures. Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019-nCoV https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html.

  • Dispose of hazardous or biologically contaminated materials according to the practices of your institution.

REAGENT STORAGE, HANDLING & STABILITY

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV should be stored at a temperature lower than -18°C in dark. The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is stable with self-life at 2-8°C for 5 days and at -18°C for 12 months. Unpacked kits should avoid repeated freeze-thaw cycles (4X). The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV can be transported at -18°C in the dark and will remain stable for 5 days.

LIMITATIONS

The use of this assay as an in vitro diagnostic under the FDA Emergency Use Authorization (EUA) is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests. Use of this assay is limited to personnel who are trained in the procedure. Failure to follow these instructions may result in erroneous results.
 

The performance of Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV was established using throat swab and bronchoalveolar lavage samples. Nasal swabs, mid-turbinate nasal swabs and nasopharyngeal swabs are also considered acceptable specimen types for use with the Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV but performance has not been established. Testing of nasal and mid-turbinate nasal swabs (self collected or collected by a healthcare provider) is limited to patients with symptoms of COVID-19. Please refer to FDA’s FAQs on Diagnostic Testing for SARS-CoV-2 for additional information.

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