Instruction Manual
Table Of Contents
- Intended Use
- Summary and Explanation
- Principles of the Procedure
- Materials Required (Provided)
- DTT solution 500mM
- SARS-CoV-2 PCR Mix
- Equipment and Supplies
- Warnings and Precautions
- Specimen Collection, Handling, and Storage
- Procedure
- For viscous samples (sputum and bronchial wash): Performed inside BSC 2
- NOTE: In the event that the test system becomes inoperable, notify supervision or designee for further direction. Patient specimens must be stored in a manner that maintains the integrity of the specimen.
- Quality Control
- Limitations
- Conditions of Authorization for the Laboratory
- Performance Characteristics
- References
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Inhibitors or other types of interference may produce a false negative result. An interference study evaluating the effect of
common cold medications was not performed.
7. Test performance can be affected because the epidemiology and clinical spectrum of infection caused by 2019-nCoV is
not fully known. For example, clinicians and laboratories may not know the optimum types of specimens to collect, and
when during the course of infection these specimens are most likely to contain levels of viral RNA that can be readily
detected.
8. Quest Diagnostics did not independently evaluate Specimen Stability and Fresh-frozen Testing. Quest Diagnostics
adopted standard practices recommended by the CDC EUA.
9. Quest Diagnostics did not perform an interfering substances study. The assay uses conventional well-established nucleic
acid extraction methods and based on our experience with other similar assays, e.g. Influenza A and B Real- Time PCR.
We do not anticipate interference from common endogenous substances. Interference studies have not been performed
for this assay.
10. Quest Diagnostics did not independently evaluate in silico sensitivity or specificity. Quest Diagnostics adopted the
evaluation performed by the Centers for Disease Control and Prevention.
11. Samples should only be pooled when testing demand exceeds laboratory capacity and/or when testing reagents are in
short supply
12. Sample pooling has only been validated using upper respiratory swab specimens.
13. Specimens that are self-collected will not be tested with an internal control to confirm that the specimen was properly
collected. Self-collected specimens from SARS-CoV-2 positive individuals may yield negative results if the specimen was
not collected properly.
14. The requirement to run a sample adequacy control for all samples that were self-collected unobserved by a healthcare
professional will be waived provided that the following disclosure has been acknowledged by the entity utilizing your home
collection kits (or notified of the disclosure via contractual notice):
Acknowledgement
(Insert Client name) acknowledges it has received the disclosure below:
Specimens that are self-collected will not be tested with an internal control to confirm that the
specimen was properly collected. Self-collected specimens from SARS-CoV-2 positive individuals
may yield negative results if the specimen was not collected properly.