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
Sore Throat Phenol Spray
15% v/v
Tobramycin
4 μg/mL
Mupirocin
10 mg/mL
Fluticasone Propionate
5% v/v
Tamiflu (Oseltamivir Phosphate)
5 mg/mL
Table 3| List of substances tested for interference
No negative interference was observed with the substances in
Table 3 tested at the indicated concentrations into SARS-CoV-
2 positive samples at 3xLoD.
High-dose effect
High dose hook effect was investigated by testing SARS-CoV-
2 Culture Fluid UV Inactivated Hong Kong/VM20001061/2020
(0810590UV, batch 326734, ZeptoMetrix Corporation) spiked
into a negative SARS-CoV-2 saliva pool. No high dose hook
effect was observed up to a level of 2.12x10
7
TCID
50
/mL.
Diagnostic sensitivity and specificity:
For nasopharyngeal specimen:
Compared with the novel coronavirus (SARS-CoV-2) real-time
RT-PCR kit executed on the nasopharyngeal samples, the
positive coincidence rate (sensitivity), negative coincidence
rate (Specificity), total coincidence/agreement of the IVD
CAPSULE COVID-19-NP test kit is presented in the table
below:
Test Specimen confirmed by
RT-PCR
IVD CAPSULE COVID-19-
NP test kit
Type of specimen
Number of
samples
Positive
Result
Negative
Result
Positive
108
90
18
Negative
301
2
299
Total results
409
92
317
Table 4| Overview of tested samples used in the validation study.
The IVD CAPSULE COVID-19-NP test kit showed the
following sensitivities/specificity in nasopharyngeal samples
compared to the reference method RT-PCR:
Clinical sensitivity: 83.3% (CI95: 74.9% - 89.8%),
Clinical specificity: 99.3% (CI95: 97.6% - 99.9%),
Total agreement rate: 95.1% (CI95: 92.6% - 97.0%).
● Sensitivity in reference to Ct intervals:
o 100.0% (CI95: 85.8% -100.0%) for Ct <25,
o 91.6% (CI95: 83.4% - 96.5%) for Ct<30,
o 86.5% (CI95: 78.5% - 92.4%) for Ct<35
For saliva specimen:
Compared with the novel coronavirus (SARS-CoV-2) real-time
RT-PCR kit executed on the saliva samples, the positive
coincidence rate (sensitivity), negative coincidence rate
(Specificity), total coincidence/agreement of the IVD
CAPSULE COVID-19-NP test kit is presented in the table
below:
Test Specimen confirmed by
RT-PCR
IVD CAPSULE COVID-19-
NP test kit
Type of specimen
Number of
samples
Positive
Result
Negative
Result
Positive
115
75
40
Negative
309
0
309
Total results
424
75
349
Table 5| Overview of tested samples used in the validation study.
The IVD CAPSULE COVID-19-NP test kit showed the following
sensitivities in saliva samples compared to the reference
method RT-PCR:
Clinical sensitivity: 69.2% (CI95: 59.5% - 77.7%),
Clinical specificity: 100.0% (CI95: 98.8% - 100.0%),
Total agreement rate: 90.6% (CI95: 87.4% - 93.2%).
● Sensitivity in reference to Ct intervals:
o 100.0% (CI95: 73.5% - 100.0%) for Ct <25,
o 85.1% (CI95: 75.0% - 92.3%) for Ct<30,
o 69.2% (CI95: 59.5% - 77.7%) for Ct<35.
References
1. https://www.who.int/health-topics/coronavirus
2. https://www.bag.admin.ch/bag/en/home/krankheiten/ausb
rueche-epidemien-pandemien/aktuelle-ausbrueche-
epidemien/novel-cov/krankheit-symptome-behandlung-
ursprung.html#1145977831
Date of issue of this document: May 05, 2022 (V1.2).
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