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16
Microorganisms from the
Same Genetic Family
High Priority Organisms
Streptococcus salivarius
FDA SARS-CoV-2 Reference Panel Testing
The evaluation of sensitivity and MERS-CoV cross-reactivity was performed using reference material (T1),
blinded samples and a standard protocol provided by the FDA. The study included a range finding study
and a confirmatory study for LoD. Blinded sample testing was used to establish specificity and to confirm
the LoD. The results are summarized in the table below.
Summary of LoD Confirmation Result using the FDA SARS-CoV-2 Reference Panel
Reference Materials
Provided by FDA
Specimen
Type
Product LoD
Cross-
Reactivity
SARS-CoV-2
Nasopharyngeal
Swab
3.0x10
5
NDU/mL
N/A
MERS-CoV
N/A
ND
NDU/mL = RNA NAAT detectable units/mL
N/A: Not app li cable
ND: Not detected
SYMBOLS
Fragile, handle with care
Test Base
Transfer Cartridge
Sample Receiver
Prescription Only
Caution, consult accompanying documents
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