LumiraDx SARS-CoV-2, Руководство пользователя

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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
testing concentration. In these cases, it was only possible to test these microorganisms at the stock
concentration.
Microorganism Source Concentration Cross-Reactivity (Yes/No)
Human coronavirus 229E Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Human coronavirus OC43 Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Human coronavirus NL63 Zeptometrix 9.87 x 10 3 PFU/mL No (3/3 negative)
MERS coronavirus Zeptometrix 7930 PFU/mL No (2/2 negative)
Adenovirus (e.g. C1 Ad. 71) Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Human Metapneumovirus
(hMPV)
Zeptometrix 1 x 10 5 PFU/mL No (3/3 negative)
Parainfluenza virus Type 1 Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Parainfluenza virus Type 2 Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Parainfluenza virus Type 3 Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Parainfluenza virus Type 4a Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Influenza A H3N2
(Wi i /6 /0 )
Zeptometrix 8.82 x 10
4
PFU/mL No (3/3 negative)
Influenza A H1N1 Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Influenza B (Malaysia/2506/04) Zeptometrix 2.92 x 10
4
PFU/mL No (3/3 negative)
Enterovirus Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Respiratory syncytial virus Zeptometrix 1 x 10
5
PFU/mL No (3/3 negative)
Rhinovirus Zeptometrix 4.17 x 10 5 PFU/mL No (3/3 negative)
Haemophilus influenzae Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Streptococcus pneumoniae Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Streptococcus pyogenes Zeptometrix 1 x 10 6 CFU/mL No (3/3 negative)
Candida albicans Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Pooled human nasal wash LumiraDx 14% v/v No (3/3 negative)
Bordetella pertussis Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Mycoplasma pneumoniae ATCC 1 x 10 6 CFU/mL No (3/3 negative)
Chlamydia pneumoniae ATCC 1 x 10
6
CFU/mL No (3/3 negative)
Legionella pneumophila Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Mycobacterium tuberculosis Zeptometrix 1 x 10 6 CFU/mL No (3/3 negative)
Pneumocystis jirovecii Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Pseudomonas Aeruginosa Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
Staphylococcus Epidermidis Zeptometrix 1 x 10 6 CFU/mL No (3/3 negative)
Streptococcus Salivarius Zeptometrix 1 x 10
6
CFU/mL No (3/3 negative)
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not available
for wet testing,
in silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by
the National Center for Biotechnology Information (NCBI) was used to assess the degree of protein
sequence homology.
•
For Human Coronavirus HKU1, homology exists between the SARS-CoV-2 nucleocapsid
protein and Human Coronavirus HKU1. BLAST results showed 30 sequence IDs, all
nucleocapsid protein, showing homology. Sequence ID AGW27840.1 had the highest
alignment score and was found to be 39.1% homologous across 76% of the sequences, this is
relatively low but cross-reactivity cannot be fully ruled out.
•
For SARS-Coronavirus, high homology exists between the SARS-CoV-2 nucleocapsid protein
and SARS-Coronavirus. BLAST results showed 68 sequence IDs, mostly nucleocapsid
protein, showing homology. Sequence ID AAR87518.1, had the highest alignment score
isolated from a human patient and was found to be 90.76% homologous across 100% of the
sequence. This is high and cross-reactivity is likely.