LumiraDx SARS-CoV-2, Руководство пользователя

Страница: 15 / 118

15 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
32 3/3 positive
6.2 0/3 positive
Limit of Detection Range Finding
Using the 32 TCID
50
/mL concentration, the LoD was further refined using a 2-fold dilution series (four
dilutions in total) of the gamma-irradiated SARS-CoV-2 virus made in pooled negative human nasal
matrix. These dilutions were tested in triplicate. The lowest concentration at which all (3 out of 3
replicates) were positive was treated as the tentative LoD for the LumiraDx SARS-CoV-2 Ag Test. This
was 32 TCID
50
/mL.
SARS-CoV-2 tested (TCID
50
/mL) Test Result
32 3/3 positive
16 0/3 positive
8 1/3 positive
4 0/3 positive
Limit of Detection (LoD) Confirmation
The LoD of the LumiraDx SARS-CoV-2 Ag Test was then confirmed by testing 20 replicates with
concentrations at the tentative Limit of Detection. The final LoD of the LumiraDx SARS-CoV-2 Ag Test
was determined to be the lowest concentration resulting in positive detection of twenty (20) out of twenty
(20) replicates. Based on this testing the LoD for nasal swab specimens was confirmed as: 32
TCID
50
/mL.
Starting Material
Concentration
Estimated LOD No. Positive/Total % Positive
2.8 x 10
5
TCID
50
/mL 32 TCID
50
/mL 20/20 100
Cross-Reactivity (Analytical Specificity)
Cross-reactivity of the LumiraDx SARS-CoV-2 Ag Test was evaluated by testing a panel of related
pathogens, high prevalence disease agents and normal or pathogenic flora that are reasonably likely
to be encountered in the clinical specimen and could potentially cross-react with the LumiraDx SARS
CoV-2 Ag Test including various microorganisms, viruses and negative matrix. Each organism and virus
were tested in the absence or presence of heat inactivated SARS-CoV-2 at 3 x LoD. The final
concentration of the organisms and viruses are documented in the Table below (the concentrations of
10
6
CFU/mL or higher for bacteria and 10
5
PFU/mL or higher for viruses is recommended). For a
number of microorganisms, the stock concentration was lower than or equal to the recommended