COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1171

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Manual

Target type

Nucleic acid

Specimen

Stool

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

GA-map COVID-19 Fecal Test, a Qualitative Real-Time PCR test for the detection of the 2019 novel coronavirus (SARS-CoV-2) RNA in stool samples. Features:• The Test has been developed from and validated with, human stool samples from confirmed COVID-19 positive patients (nasopharyngeal positive test results) and, stool samples from known COVID-19 negative patients. • SARS-CoV-2 target genes and controls were selected in accordance with the US Centers for Disease Control and Prevention (CDC) information for molecular detection of SARS-CoV-2. • The GA-map COVID-19 Fecal Test has been specifically developed and validated for stool specimens. • The test is CE-marked and In-vitro Diagnostic (IVD) Use for stool samples.• Results available after 5 hoursProduct description:The CE-marked GA-map COVID-19 Fecal Test is designed to qualitatively detect SARS-CoV-2 in faecal samples. Viral ribonucleic acid (RNA) is isolated from human faecal samples followed by selective amplification of the target gene using specific primers for two sequences within the SARS-CoV-2 Nucleocapsid gene (N1 and N2). RNA detection probes labeled with a fluorescent dye act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. The real-time data is recorded in a real-time (RT)-PCR instrument and the results are reported as either positive or negative based on cycle threshold (Ct) recordings.Benefits:• Detect gastrointestinal COVID-19 infection• Non-invasive and Easy self-sampling sample collection• Highly specific RT- PCR test for the identification of SARS-CoV-2 in faeces• Fast and accurate detection of SARS-CoV-2 RNA presence in stool over an extended period compared to the few days’ detection window from nasopharyngeal samples using robust RT-PCR technique.• Internal Control, Human RNaseP (RP) gene amplified with dedicated primers for every sample• May help with confirmation of Covid-19 clearance and management of social distancing/return to work policiesApplicable to:• patients exhibiting signs and symptoms of COVID-19 (confirmation and management)• patients in the recovery phase (surveillance and clearance)• asymptomatic individuals concerned about possessing and transmitting the virus (prevention)• Screening faecal microbiota transplant (FMT) donors http://www.genetic-analysis.com/new-covid-19

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

No

Method

RT-PCR

Time

300 minutes

LOD

14 copies/μl

Positive control

GA-map COVID-19 Positive Control + intern control (Human RNaseP (RP) gene)

Negative control

GA-map dH2O

Analytical Sensitivity

99.8 %

Analytical Specificity

100 %

Throughput

96 samples per run

Notes

Information provided by the manufacturer