LumiraDx SARS-CoV-2, Руководство пользователя

Страница: 11 / 118

11 of 21
Document Name: SARS-CoV-2 Ag Test Strip Product Insert
Document Number: S-COM-DOUT-00112 Revision: 2
This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for
the most recent version unless formally issued and stamped by QA. Created with S-QMS-TEM-00001
Limitations
•
This test detects both viable (live) and non-viable, SARS-CoV and SARS-CoV-2. Test
performance depends on the amount of virus (antigen) in the sample and may or may not
correlate with viral culture results performed on the same sample.
•
Failure to follow the instructions for use may adversely affect test performance and/or invalidate
the test result.
•
Test results should be considered in the context of all available clinical and diagnostic information,
including patient history and other test results.
•
Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
•
Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
•
Negative results, from patients with symptom onset beyond twelve days, should be treated as
presumptive and confirmation with a molecular assay, if necessary for patient management, may
be performed.
•
If the differentiation of specific SARS viruses and strains is needed, additional testing, in
consultation with state or local public health departments, is required.
•
Clinical performance was established on frozen specimens and performance may be different
with fresh clinical specimens.
•
Users should test specimens as quickly as possible after specimen collection.
•
Extracted nasal specimens may be frozen at -80°C and used up to 5 days after freezing.
•
Specimens and Extraction buffer must be at room temperature before testing.
•
Positive test results do not rule out co-infection with other pathogens
•
A false negative result may occur if the level of viral antigen in a sample is below the detection
limit of the test or if the sample was collected inappropriately, therefore a negative test result does
not rule out the possibility of SARS-CoV-2 infection.
•
The amount of antigen in a sample may decrease as the duration of illness increases. Specimens
collected after 12 days are more likely to be negative compared to RT-PCR.
•
The contents of this kit are for qualitative detection of SARS-CoV-2 antigens from nasal swab
specimens only.
•
The following swabs have been validated for use with the LumiraDx SARS-CoV-2 Ag Test: Nasal
FLOQswab, Medline Disposable Sampler and Puritan HydraFlock and performance with other
swabs may be different.
Conditions of Authorization for the Laboratory
The LumiraDx SARS-CoV-2 Ag Test Letter of Authorization, along with the authorized Fact Sheet for
Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on
the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices/vitro-diagnostics-euas .
However, to assist clinical laboratories using the LumiraDx SARS-CoV-2 Ag Test (“your product” in
the conditions below), the relevant Conditions of Authorization are listed below:
•
Authorized laboratories
1
using your product will include with test result reports, all authorized Fact
Sheets. Under exigent circumstances, other appropriate methods for disseminating this labeling
may be used, which may include mass media.
•
Authorized laboratories using your product will use your product as outlined in the authorized
labeling. Deviations from the authorized procedures, including the authorized instruments,