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
•
For MERS-Coronavirus, high homology exists between the SARS-CoV-2 nucleocapsid protein
and MERS-Coronavirus. BLAST results showed at least 114 sequence IDs, mostly
nucleocapsid protein, showing homology. Sequence IDs AHY61344.1 and AWH65950.1, had
the highest alignment scores isolated from a human patient and were found to be 49.4% and
50.3% homologous across 88% of the sequence. Whilst this potentially represents moderate
cross-reactivity testing of the MERS virus at 7930 PFU/mL showed no reactivity (see table
above).
Microbial Interference Studies
Microbial interference in 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 to demonstrate that false
negatives do not occur when SARS-CoV-2 is present in a specimen with other microorganisms
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 testing concentration. In these
cases, it was only possible to test these microorganisms at the stock concentration.
Microorganism Source Concentration Interference (Yes/No)
Human coronavirus 229E Zeptometrix 1 x 10
5
PFU/mL No (3/3 positive)
Human coronavirus OC43 Zeptometrix 1 x 10 5 PFU/mL No (19/20 positive)
Human coronavirus NL63 Zeptometrix 9.87 x 10
3
/
No (3/3 positive)
MERS coronavirus Zeptometrix 7930 PFU/mL No (3/3 positive)
Adenovirus (e.g. C1 Ad. 71) Zeptometrix 1 x 10 5 PFU/mL No (3/3 positive)
Human Metapneumovirus
( )
Zeptometrix 1 x 10
5
PFU/mL No (3/3 positive)
Parainfluenza virus Type 1 Zeptometrix 1 x 10
5
PFU/mL No (3/3 positive)
Parainfluenza virus Type 2 Zeptometrix 1 x 10 5 PFU/mL No (3/3 positive)
Parainfluenza virus Type 3 Zeptometrix 1 x 10
5
PFU/mL No (3/3 positive)
Parainfluenza virus Type 4a Zeptometrix 1 x 10
5
PFU/mL No (3/3 positive)
Influenza A H3N2
(Wi i /6 /0 )
Zeptometrix 8.82 x 10
4
PFU/ L
No (3/3 positive)
Influenza A H1N1 Zeptometrix 1 x 10 5 PFU/mL No (3/3 positive)
Influenza B (Malaysia/2506/04) Zeptometrix 2.92 x 10
4
PFU/ L
No (19/20 positive)
Enterovirus Zeptometrix 1 x 10
5
PFU/mL No (3/3 positive)
Respiratory syncytial virus Zeptometrix 1 x 10 5 PFU/mL No (3/3 positive)
Rhinovirus Zeptometrix 4.17 x 10
5
PFU/ L
No (3/3 positive)
Haemophilus influenzae Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Streptococcus pneumoniae Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Streptococcus pyogenes Zeptometrix 1 x 10 6 CFU/mL No (3/3 positive)
Candida albicans Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Pooled human nasal wash LumiraDx 14% v/v No (3/3 positive)
Bordetella pertussis Zeptometrix 1 x 10 6 CFU/mL No (3/3 positive)
Mycoplasma pneumoniae ATCC 1 x 10
6
CFU/mL No (3/3 positive)
Chlamydia pneumoniae ATCC 1 x 10
6
CFU/mL No (3/3 positive)
Legionella pneumophila Zeptometrix 1 x 10 6 CFU/mL No (3/3 positive)
Mycobacterium tuberculosis Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Pneumocystis jirovecii Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Pseudomonas Aeruginosa Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Staphylococcus Epidermidis Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)
Streptococcus Salivarius Zeptometrix 1 x 10
6
CFU/mL No (3/3 positive)