User Manual

IVD CAPSULE COVID-19-NP - Instructions for Use (IFU)
REF P02.00048
IFU IVD CAPSULE COVID-19-NP 2022_05_EN_V1.2
Limitations
• Eating, drinking, or smoking within 30 min before the test
may adversely affect the test performance.
• Failure to correctly follow the test procedure may
adversely affect the test performance and/or invalidate the
test result.
• A false-negative test 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 or transported improperly;
therefore, a negative test result does not eliminate the
possibility of SARS-CoV-2 infection.
• Positive test results do not rule out co-infections with other
pathogens.
• Negative test results are not intended to rule out other viral
or bacterial infections.
• Negative results should be treated as presumptive and
confirmed with a molecular test if COVID-19 disease is
suspected.
• The collected specimens should be tested as quickly as
possible after collection.
• All assay materials are single-use and cannot be re-used.
• Clinical performance was evaluated with frozen samples,
and test performance may be different with fresh samples.
• The amount of antigen in a sample may decrease as the
duration of illness increases. Specimens collected after
day 5 of illness are more likely to be negative compared to
a RT-PCR assay.
• Monoclonal antibodies may fail to detect, or detect with
less sensitivity, SARS-CoV-2 viruses that have undergone
minor amino acid changes in the target epitope region.
The user shall report any serious incident that has occurred in
relation to the device to the manufacturer and the relevant
national competent authority.
Performance characteristics
Analytical sensitivity:
LoD was determined by spiking SARS-CoV-2 Culture Fluid UV
Inactivated Hong Kong/VM20001061/2020 (0810590UV, batch
326734, ZeptoMetrix Corporation) into a negative SARS-CoV-
2 saliva pool or artificial nasopharyngeal matrix. In a first phase,
a 10-fold dilution series, starting from a target concentration of
10
5
TCID
50
/ml was performed. Each dilution was tested in 3
replicates on abioSCOPE 2.0. The lowest concentration to give
3 positive results was selected to measure a 2-fold dilution
series where each dilution is tested in 3 replicates on the
abioSCOPE 2.0.
The lowest concentration to give 3 positive results was 755
TCID
50
/mL. When tested in 20 replicates this dose gave 20 out
of 20 results. The limit of detection (LoD) within a 95%
confidence interval for IVD CAPSULE COVID-19-NP is 755
TCID
50
/mL.
Microbial interferences:
The IVD CAPSULE COVID-19 assay was tested for cross-
reactivity and interference using bacteria and viruses that are
reasonably likely to be encountered in respiratory clinical
specimens, and no cross-reactions nor interferences were
observed at the concentrations as listed below:
Cross-reactant
Conc.
Adenovirus Type 5 (Hexon protein)
1 µg/mL
Candida albicans (antigen, Purified lysate)
1 µg/mL
Enterovirus (antigen, Recombinant antigen)
1 µg/mL
Human Coronavirus 229E (Purified viral Lysate)
1 µg/mL
Human Coronavirus NL63 (Purified viral Lysate)
1 µg/mL
Human Coronavirus OC43 (Purified viral Lysate)
1 µg/mL
Human Metapneumovirus 9 (Type A1, Lysate)
1 µg/mL
Human Parainfluenza Virus (Type 1, Lysate)
1 µg/mL
Human Parainfluenza Virus (Type 2, Lysate)
1 µg/mL
Human Parainfluenza Virus (Type 3, Lysate)
1 µg/mL
Human Parainfluenza Virus (Type 4A, Lysate)
1 µg/mL
Human Parainfluenza Virus (Type 4B, Lysate)
1 µg/mL
Influenza A (A/Brisbane/10/2007 (H3N2), Lysate)
1 µg/mL
Influenza A (A/New Caledonia/20/1999 (H1N1),
Lysate)
1 µg/mL
Influenza B (B/Brisbane/33/08 Lysate)
1 µg/mL
Coronavirus Spike Glycoprotein (MERS, S1, Camel
Fc-Tag (HEK293), Recombinant protein)
1 µg/mL
Mycoplasma pneumoniae (Purified lysate)
1 µg/mL
Respiratory Syncytial Virus A (Type A, Lysate)
0.1 µg/mL
Respiratory Syncytial Virus B (Type B, Lysate)
1µg/mL
Rhinovirus (Type 1A, Lysate)
1 µg/mL
Coronavirus HKU1 (Recombinant nucleoprotein)
1 µg/mL
Coronavirus HKU1 (Recombinant spike protein)
1 µg/mL
SARS-CoV (SARS-CoV-1, Recombinant
nucleoprotein)
0.1 µg/mL
Bordetella pertussis (Lysate)
1 µg/mL
Bordetella pertussis toxin (Toxin)
1 µg/mL
Chlamydophila pneumoniae Antigen (CWL-029,
Native extract)
1 µg/mL
Nasal Irrigation/Wash - Normal (Pooled human
donors)
N/A
Table 2| Bacteria and viruses tested for cross-reactivity
Analytical selectivity:
No positive interference was observed with the following
substances tested at the indicated concentrations into SARS-
CoV-2 negative sample:
Interfering substance
Conc.
Whole Blood
4%
Mucin
2.5% w/v
Chloraseptic (Menthol/Benzocaine)
1.5 mg/mL
Naso GEL (NeilMed)
5% v/v
CVS Nasal Drops (Phenylephrine)
15% v/v
Afrin (Oxymetazoline)
15% v/v
CVS Nasal Spray (Cromolyn)
15% v/v
Zicam
5% w/v
Homeopathic (Alkalol)
1:10 dilution