INTENDED USE:                                                                                                                                                                                     

The HB BestPlex^TM COVID-19 RT-PCR Kit is a multiplex real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal or oropharyngeal swab from individuals exhibiting signs and symptoms for COVID-19. Results of this RT-PCR test are for the identification of SARS-CoV-2 RNA. A positive result indicates the presence of SARS-CoV-2 RNA in the collected specimen. However, this does not rule out the possibility of co-infection with other viruses or bacteria. All positive results need to be reported to proper public health authorities in the United States. Negative results by this kit do not preclude SARS-CoV-2 infection. Definitive diagnosis must be considered with other clinical observations, patient history and epidemiological information. The HB BestPlex^TM COVID-19 RT-PCR Kit is intended to use by well-trained laboratory personnel for the techniques and diagnostic procedure of real-time PCR. Testing with the HB BestPlex^TM COVID-19 RT-PCR Kit is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests or by similarly qualified non U.S. laboratories.

The HB BestPlex^TM COVID-19 RT-PCR Kit is a multiplex real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal or oropharyngeal swab from individuals exhibiting signs and symptoms for COVID-19.

Results of this RT-PCR test are for the identification of SARS-CoV-2 RNA. A positive result indicates the presence of SARS-CoV-2 RNA in the collected specimen. However, this does not rule out the possibility of co-infection with other viruses or bacteria. All positive results need to be reported to proper public health authorities in the United States. Negative results by this kit do not preclude SARS-CoV-2 infection. Definitive diagnosis must be considered with other clinical observations, patient history and epidemiological information.

The HB BestPlex^TM COVID-19 RT-PCR Kit is intended to use by well-trained laboratory personnel for the techniques and diagnostic procedure of real-time PCR. Testing with the HB BestPlex^TM COVID-19 RT-PCR Kit is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests or by similarly qualified non U.S. laboratories.

SPECIFICATION:

- Results within 1.5 hour after extraction
- One-Step RT Real-Time PCR (Only require RNA template)
- All reagents (cDNA synthesis & qPCR analysis) are included
- The validity of RT-PCR reaction is precisely verified by using Positive Control

COMPATIBILITY:                                                                                                                                                                                          

- CFX96 Real-time PCR Detection System-IVD [Bio-Rad]
- Applied Biosystems 7500 Fast Dx platform-IVD [ABI]

PACKAGE:

- 150 rxns/Kit [HBVRP-CoV101]
- 450 rxns/Kit [HBVRP-CoV201]
- 3,600 rxns/Kit [HBVRP-CoV301]