COVID-19CPS CW008NCT05492227
SARS-CoV-2 Nucleic Acid Detection Kit Clinical Performance Study
An observational study of COVID-19 and Coronavirus Disease 2019, run by TransGen Biotech Co., LTD at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Coronavirus Disease 2019, COVID-19 Pandemic
- What is being tested?
- Left-overs
- How many people
- 607 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Biobanco del Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: SARS-CoV-2 Nucleic Acid Detection Kit
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).
Read the 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.
- Being tested
- Left-overs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left-oversDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Left-overs | |
| 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). Receives: Diagnostic Test: Left-overs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the procedure
Secondary outcomes (1)
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).
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start5 Jul 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransGen Biotech Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492227
- Sponsor's protocol ID
- CW008
- Acronym
- CPS CW008
- Status last verified
- May 2023
- First submitted
- 2 Aug 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Nucleic Acid Detection Kit
- ClinicalTrials.gov ID
- NCT05492227
- Acronym / sponsor ID
- CPS CW008 / CW008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- TransGen Biotech Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh left-over specimens of SARS-CoV-2 positive subject swabs | – | Diagnostic Test: Left-oversAll 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). |
| Fresh left-over specimens of SARS-CoV-2 negative subject swabs | – | Diagnostic Test: Left-oversAll 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left-oversTotally 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. | Diagnostic test | Fresh left-over specimens of SARS-CoV-2 negative subject swabs, Fresh left-over specimens of SARS-CoV-2 positive subject swabs |
Primary outcome
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.
1 secondary outcome
Specificity of the SARS-CoV-2 NAD Kit
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus Disease 2019, run by TransGen Biotech Co., LTD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the SARS-CoV-2 NAD Kit (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.