CE MarkRT-25HT501

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Covid-19 HT Screen 501

COVID-19 HT Screen 501  is an in vitro diagnostic test for the detection of the N1, N2 region and of SARS-CoV-2 spike protein N501Y mutation, by one-step Real-Time RT-PCR. 


Clonit R&D Dept., states that, as from latest sequence analysis, the BA.4 and BA.5 sub-lineages of the Omicron variant, don’t affect the diagnostic performances of Covid-19 HT Screen 501 and COVID-19 HT Screen assays.



Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. Like other coronaviruses, the SARS-CoV-2 genome consists of a positive-sense single-stranded RNA (+ssRNA). The viral genome is stabilized by the nucleocapsid protein (N) and enveloped in a bilipid structure comprising the membrane protein (M), spike protein (S) and envelope protein (E). The +ssRNA strand has 14 open reading frames (ORFs) coding for structural proteins (N, S, E, M), non-structural proteins or nsps (ORF1 and ORF1ab) required for viral replication and assembly and accessory proteins (ORF3, ORF4a, ORF4b, ORF5, ORF8). Many variants of the SARS-CoV-2 coronavirus have arisen over the course of the pandemic. Some spread around the world, while others quickly faded away or were supplanted by other variants. The key N501Y mutation on the receptor-binding domain (RBD) arose independently in several variants of concern, including Alpha, Beta, Gamma and Omicron. The mutation is near the tip of the coronavirus spike, where it seems to change the shape of the protein to be a tighter fit with human cells.


Three common clusters of symptoms have been reported in SARS‑CoV‑2 infection: one respiratory symptom cluster with cough, sputum, shortness of breath, and fever; a musculoskeletal symptom cluster with muscle and joint pain, headache, and fatigue; a cluster of digestive symptoms with abdominal pain, vomiting, and diarrhea.


The RT-PCR is considered the gold standard for SARS-CoV-2 detection from patient nasopharyngeal samples.


Technical details 

COVID-19 HT Screen 501 is a qualitative test that allows the identification of the N1, N2 region and of SARS-CoV-2 spike protein N501Y mutation in subjects with suspected COVID-19 infection. 


  • N1 gene of SARS-CoV-2 genome
  • N2 gene of SARS-CoV-2 genome
  • N501Y mutation
  • Internal Control (IC)

Diagnostic samples:

  • nasopharyngeal/oropharyngeal swabs 

Real-Time PCR instruments:

  • Applied Biosystems 7500 Fast (ThermoFisher SCIENTIFIC)
  • Rotor-Gene Q MDx (RG-Q MDx - QIAGEN)
  • CFX96 Real-Time PCR Detection System (Bio-Rad)

RNA Extraction:

Manual Extraction with:

  • QIAmp Viral RNA Mini Kit (QIAGEN)

Automatic Extraction with:

  • CloNext 12 or CloNext 24 (ref. OP01018/OP01019) robotic workstation 
  • Duplicα®Prep (ref. EDI001 or EDI003) robotic workstation 
  • QIAsymphony SP/AS (Ref. 9001297/9001301, QIAGEN) 
  • Automated Liquid Handlers equipped with the protocol for the Mag-Bind® Viral RNA XPress Kit from Omega BIO-TEK

See the complete line of products designed by Clonit for the identification of SARS-CoV-2 infection: