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

NCT ID: NCT05492227

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 607 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2022-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fresh left-over specimens of SARS-CoV-2 positive subject swabs

All fresh swab specimens that were sent to the biobank Hospital Puerta del Hierro between March 2020 and December 2021 under the standard requirements for SARS-CoV-2 specimens (ISO 201916) were kept frozen (-80ºC) after analysis by RT-PCR (left-over samples).

Left-overs

Intervention Type: 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.

Fresh left-over specimens of SARS-CoV-2 negative subject swabs

All fresh swab specimens that were sent to the biobank Hospital Puerta del Hierro between March 2020 and December 2021 under the standard requirements for SARS-CoV-2 specimens (ISO 201916) were kept frozen (-80ºC) after analysis by RT-PCR (left-over samples).

Left-overs

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TransGen Biotech Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biobanco del Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Countries

Spain

Other Identifiers

CW008

Identifier Type: -

Identifier Source: org_study_id