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
English
Intended use
The IVD CAPSULE COVID-19-NP is a single use, rapid in vitro
diagnostic test intended for the qualitative detection of SARS-
CoV-2 viral nucleocapsid antigens in nasopharyngeal
specimens from individuals suspected of SARS-CoV-2
infection.
The IVD CAPSULE COVID-19-NP is intended to be used in
conjunction with the abioSCOPE 2.0 in vitro diagnostic test
system for professional use in near-patient/point of care (PoC)
locations.
In conjunction with accessory REF P04.00019 (saliva swab)
saliva specimens can be collected and analyzed instead of
nasopharyngeal specimens.
Summary
COVID-19 is the infectious disease caused by the recently
discovered SARS-CoV-2. The virus is spread by human-to-
human transmission through droplets of saliva or discharge
from the nose when an infected person coughs or sneezes.
1
The most common symptoms of COVID-19 are fever, dry
cough, tiredness, headache, shortness of breath, sore throat,
aches and pains.
1
However, some people are infected but do
not develop any symptoms and do not feel unwell.
2
Older
people and those with underlying medical problems like
cardiovascular disease, chronic respiratory disease, diabetes,
and cancer are more likely to require hospitalization.
Current epidemiological findings show that the incubation
period can be up to 14 days while it is most often within 4 to 7
days
1,2
.
Test principle
The nasopharyngeal (or saliva) sample is first collected from
the nasopharynx (or the mouth) using a swab, and then mixed
with a solution composed of a fluorescently labeled antibody
reactive to SARS-CoV-2 nucleocapsid antigen. The collected
sample, now containing the complex of SARS-CoV-2 antigen
and antibodies, is loaded onto the capsule of the kit.
Patient material is drawn through the capsule by capillary
action and passes through a built-in separator that excludes
particles from the measurement area.
After passing through the separator, the SARS-CoV-2-antibody
complex is bound by antibodies immobilized on the capsule’s
read-out area.
In the case where sufficiently high concentrations of SARS-
CoV-2 antigen are present in the sample, a fluorescence signal
above the limit of detection is generated by the fluorophore
conjugated to the signal antibody. The abioSCOPE (REF
P01.00007) reader will detect this signal, process it and display
a message whether the patient is SARS-CoV-2 infected
(“positive”) or not (“negative”), or “failed” in case of an invalid
procedure.
Reagents
Each assay contains one squeeze tube with a drop-dispensing
cap containing 150 l of the abioMIX reagent. The abioMIX
reagent is composed of the fluorescently labeled anti-
nucleocapsid antibody, dissolved in a viral lysis buffer. The
abioMIX reagent also contains a preservative (Table 1).
Ingredient
Conc.
Fluorescently labelled anti-nucleocapsid antibody
1.4 g/ml
Tris-HCl
150 mM
Sodium Chloride
450 mM
Deoxycholic Acid
0.75%
NP-40
3%
EDTA
3 mM
ProClin300 (CAS number 55965-84-9)
0.04% (v/v)
Table 1| Composition of the abioMIX reagent.
Materials included
• 1x COVID-19 capsule
• 1x squeeze tube of abioMIX reagent including a drop-
dispensing cap
• 1x CE-marked swab for nasopharyngeal sample
collection (provided separately outside of the blister
package).
• 1x desiccant bag
• 1 x printed Instructions for Use (IFU)
Not included in the kit: 1x swab for saliva (accessory to be
ordered separately, REF P04.00019).
Test procedure
1. Allow the abioMIX reagent to warm up to room
temperature (about 10 min) before opening and use
immediately after.
2. The test subject shall not eat, drink or smoke for 30 min
before the test.
3. It is recommended to put on protective gloves before
starting the procedure.
4. Initiate the abioSCOPE analyser
• Make sure that the abioSCOPE is switched on and
ready to measure.
5. To start using the IVD Capsule COVID-19-NP kit, open
the blister package, and keep it within reach in your
working space. The reagent tube can already be removed
from the package if required but it should not be opened
yet.