Test Overview
DiaSorin Molecular Simplexa RT-PCR
The DiaSorin Molecular Simplexa™ COVID-19 Direct assay system is a real-time RT-PCR system that enables the direct amplification of Coronavirus SARS-CoV-2 RNA primarily from nasopharyngeal swabs (NPS) in patients suspected of COVID-19 by their health care provider.
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 co-infection with other pathogens. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Not detected
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
The performance of this device has not been specifically assessed in individuals without signs or symptoms of respiratory infection. This test is a qualitative test and does not provide the quantitative value of detected organisms present. Use of 1 mL transport media may result in an increased rate of Internal Control (IC) failures with some patient specimens. This may be due to a higher concentration of inhibitors present when a patient’s nasopharyngeal or nasal swab is placed into 1 mL transport media compared to 3 mL transport media. Invalid results indicate the inability to conclusively determine presence or absence of SARS-CoV2 RNA in the patient sample. This result may be due to 1) Internal Control (IC) failure, or 2) failure to detect sufficient specimen volume.
Test Details
The test will be performed multiple times per day with results reported within 6 hrs of receipt of specimen in the laboratory contingent upon testing capacity.
- SARS-CoV-2
Specimen Requirements
Specimen Collection: With the head in a tiled position, insert the swab into one nostril, advancing into the nasopharynx until resistance is felt. Rotate the swab several times on the nasopharyngeal membrane to allow adequate collection of epithelial cells - a minimum of 3 "full twists" is standard to obtain a good collection; if unsure you maintained contact with the membrane, add another 1-2 full twists.
Use only swabs with a synthetic tip (e.g. Dacron, nylon, or rayon) and an aluminum or plastic shaft. Do not use calcium alginate swabs, as they may contain substances that inhibit PCR testing.
Insert swab into viral transport media. Break off swab stick at the breakpoint to ensure it will fully fit into the closed tube. Fasten the cap tightly to prevent leakage.
Nasal swabs also acceptable but not preferable
Nasopharyngeal swab in viral transport media (BD UVT, Copan UTM or equivalent)
>7 days freeze at -70°C
Additional Information
Assay lower limit of detection: 500 copies/mL (0.5 copies/µL)