COVID-19 HT Screen

COVID-19 HT Screen is an in vitro diagnostic test for the detection of the N region (nucleocapsid phosphoprotein) of SARS-CoV-2, by one-step Real-Time RT-PCR.

Note:

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.

Overview

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).

Symptoms

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.

Diagnosis

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

Technical details

COVID-19 HT Screen is a qualitative test that allows the identification of the N region (nucleocapsid phosphoprotein) of SARS-CoV-2 in subjects with suspected COVID-19 infection.

Target:

N gene of SARS-CoV-2 genome
Internal Control (IC)

Diagnostic samples:

nasopharyngeal/oropharyngeal swabs
pure saliva samples

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

Fast Extraction:

Clonit recommends the procedure deriving from the protocol of the Yale School of Public Health and validated at the Department of Health Sciences - University of Milan.