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

NCT05492227 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 607

Last updated 2023-05-18

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • TransGen Biotech Co., LTD

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05492227 on ClinicalTrials.gov