Clinical trial NCT05492227: SARS-CoV-2 Nucleic Acid Detection Kit Clinical Performance Study
Official title: SARS-CoV-2 Nucleic Acid Detection Kit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Coronavirus Disease 2019
COVID-19 Pandemic
Diagnoses Disease
Lead sponsor: TransGen Biotech Co., LTD
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 607
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The specimens used in this clinical performance study are leftovers previously collected from male and female subjects suspected of SARS-CoV-2 infection through a nasopharyngeal swab.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the SARS-CoV-2 NAD Kit
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Specificity of the SARS-CoV-2 NAD Kit
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Biobanco del Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
References: