SARS-CoV-2 Test

SARS-CoV-2 test is a rapid nucleic acid microarray-qPCR test intended for in vitro qualitative detection of SARS-CoV-2 in nasopharyngeal, nasal or throat swabs collected from individuals with or without symptoms, or other epidemiological reasons to suspect of COVID-19 infection. The test is run using FlashDx-1000-E or other compatible FlashDx systems. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARSCoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Rapid and robust detection of SARS-CoV-2 with 3 gene targets tested simultaneously: N, E and ORF1ab genes.
Sample Types :
– Specimen: Nasopharyngeal, nasal or throat swabs
– Transport Media: UTM/VTM or saline (0.9%) (Use recommended UTM/VTM only. Transport media with guanadine buffer is not compatible)
Instrument : FlashDx-1000-E
Technology : Microarray-qPCR
Targets : N, E, and ORFlab genes
Batch or On-Demand : On-Demand
Minimum Batch Size : 1
Sample Extraction : Fully automated/integrated
Precision Pipetting : Not required
Turnaround Time : < 1 hour Hands-on Time : ~ 1 minute Control : Internal Process Control Clinical Evaluation (Compared to an FDA EUA RT-PCR assay) : - Sensitivity 95.2% (95% Cl: 88.1% - 98.7%) - Specificity 97.3% (95% Cl: 90.7% - 99.7%) (Testing performed with 83 positives and 75 negatives) Commercial Controls : contact our customer service

CE marked ; Nasopharyngeal,nasal or throat swabs ; FlashDx-1000-E ; Test : SARS-CoV-2 / +2° to +8° C. / IVDD-CE-UKCA

Product Insert.pdf