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

Study Overview
=================
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.

Official Title
-----------------
SARS-CoV-2 Nucleic Acid Detection Kit

Conditions
-----------------
COVID-19, Coronavirus Disease 2019, COVID-19 Pandemic, Diagnoses Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Left-overs


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fresh left-over specimens of SARS-CoV-2 positive subject swabs<br>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). | Diagnostic Test: Left-overs<br>* 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.<br>|
| Fresh left-over specimens of SARS-CoV-2 negative subject swabs<br>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). | Diagnostic Test: Left-overs<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |