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Solgent PCR DiaPlexQ™
Solgent PCR DiaPlexQ™
Solgent PCR DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit
Real-Time OneStep RT-PCR based assay system for detection of 2019-nCoV
Product Certificate
KFDA-EUA, U.S FDA EUA, Health Canada EUA, CE-IVD
The DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit is a real-time reverse transcriptase (RT)-PCR
test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs,
oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal
washes, bronchoalveolar lavage (BAL) fluid and sputum from individuals suspected of COVID-19 by their
healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in
respiratory specimens during the acute phase of infection. Positive results are indicative of the presence
of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary
to determine patient infection status. The agent detected may not be the definite cause of disease.
Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for
patient management decisions. Negative results must be combined with clinical observations, patient
history, and epidemiological information.
The DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit is intended for use by qualified clinical
laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro
diagnostic procedures.
