SARS-CoV-2 Nucleic Acid Detection Kit Clinical Performance Study

SARS-CoV-2 Nucleic Acid Detection Kit is an In Vitro Diagnostic (IVD) medical device intended for RNA detection of SARS-CoV-2 in human specimens using multiplex real-time polymerase chain reaction (RT-PCR) technology. The conserved regions of ORF1ab and N genes are used as target sites of the primers and probes according to the indications provided in the Instructions for Use (IFU).

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Key information

Conditions

COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Disease 2019 Coronavirus Infections Diagnoses Disease Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Biobanco del Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

About this study

The SARS-CoV-2 Nucleic Acid Detection Kit is an In Vitro Diagnostic (IVD) medical device intended for Qualitative RNA detection of SARS-CoV-2 using multiplex real time RT-PCR technology for professional use. The kit is available in two different formats (48 tests/kit or 200tests/kit), and it can be stored at -20±5ºC away from light for 12 months. This kit includes a PCR Reaction Mix, PCR Enzyme Mix, SARS-CoV-2 PCR Primer/Probe Mix and a negative/positive control.

TransGen SARS-CoV-2 Nucleic Acid Detection Kit is intended for in vitro qualitative detection of ORF1ab and N genes from the SARS-CoV-2 virus in nasopharyngeal swab specimens collected from COVID-19 suspected cases, suspected clusters of cases or other individuals who need SARS-CoV-2 infection diagnosis or differentiation diagnosis. The definitions of COVID-19-related groups, such as "suspected cases" or "suspected clusters of cases", are detailed in the Diagnosis and Treatment Protocol for Novel Corona virus Pneumonia, Surveillance Protocol for Novel Corona virus Pneumonia or other COVID-19 documents from the Centers for Disease Control and Prevention (CDC). The TransGen SARS-CoV-2 Nucleic Acid Detection Kit should comply with the requirements of Diagnosis and Treatment Protocol for Novel Corona virus Pneumonia, Protocol for Prevention and Control of COVID-19 and other COVID-19 documents from the CDC. The biosafety requirements should be strictly followed as well.

Specimens used for this clinical performance study will be remnants of specimens taken for purposes of standard of care (leftover or archived) through a nasal swab from male and female subjects. Specimens may come from persons suspected of SARS-CoV-2 infection but also from those who need a diagnostic test due to other reasons such as medical intervention, blood donors, or travel for which a negative test is requested.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Specimen collected with a nasal swab.
Negative samples from specimens confirmed SARS-CoV-2 negative by the gold standard, or positive samples from specimens confirmed SARS-CoV-2 positive by the gold standard.

Exclusion criteria

Specimens that have been stored at 4ºC for more than 24h
Specimens stored at -70ºC that have been under more than 2 freeze/thaw cycles
Specimens that have been stored at -20 for more than 10 days
Contamination and/or deterioration of the specimen that, in the investigator's opinion, may impact its handling and/or analysis

Treatment and study plan

Left-overs

Diagnostic Test

Totally nasal swab leftovers were stored from the biobank of Hospital Puerta del Hierro. The coded specimens were kept at -80°C and analyzed using the SARS-CoV-2 NAD Kit. Previously these specimens were analyzed using the gold-standard RT-PCR.

Primary outcomes

Sensitivity of the SARS-CoV-2 NAD Kit

Time frame: Immediately after the procedure

The investigators assessed the sensitivity as the capacity to correctly detect positive specimens of SARS-CoV-2 infection previously confirmed as positive (True Positive, TP) by the gold standard RT-PCR.

Secondary outcomes

Specificity of the SARS-CoV-2 NAD Kit

Time frame: Immediately after the procedure

The investigators assessed the specificity as the ability to correctly classify previously confirmed as SARS-CoV-2 negative specimens by the gold standard RT-PCR, as negative (True Negative, TN).

Sponsors and collaborators

Lead sponsor

TransGen Biotech Co., LTD

Industry

Registry information

Official study title

SARS-CoV-2 Nucleic Acid Detection Kit

Acronym: CPS CW008

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Aug 8, 2022
Registry last updated: May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed