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

COVID-19 Clinical Trial

— CPS CW008  

Official title:

SARS-CoV-2 Nucleic Acid Detection Kit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492227
• Other study ID #: CW008
• Status: Completed
• Start date: July 5, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: TransGen Biotech Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 607
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• COVID-19
• COVID-19 Pandemic
• Diagnoses Disease

Intervention

Diagnostic Test:
• Left-overs
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.

Locations

Country	Name	City	State
Spain	Biobanco del Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
TransGen Biotech Co., LTD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the SARS-CoV-2 NAD Kit	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.	Immediately after the procedure
Secondary	Specificity of the SARS-CoV-2 NAD Kit	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).	Immediately after the procedure