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
12. Measurement in the abioSCOPE analyser
• Press the measurement button on the screen. The
tray of the abioSCOPE will automatically open.
• Place the capsule inside and press the close tray
button.
• Add the patient information in the following fields.
After confirmation (push next step) the measurement
is automatically initiated.
13. After the measurement process (within 2 minutes) the
result of the test is directly displayed on the screen (in a
coded form if required) and stored in abioSCOPE’s
internal memory.
14. Dispose the used device (abioMIX tube, capsule and
swab) according to your local regulations and biohazard
waste disposal protocol.
Interpretation of results of the test
A positive result indicates that the patient (very probably) has
contracted COVID-19 and that he/she should contact a medical
doctor for further information and instructions.
In case of a negative result the patient is (probably) not
infected. It is still advised to closely follow the protection and
hygiene measures.
In case that an invalid/failed result is displayed, a retest should
be done with a new capsule.
Storage and stability
To be stored at 2-8 °C up to the expiration date printed on the
label. The abioMIX reagent is ready-to-use. Allow the abioMIX
reagent to warm up to room temperature (about 10 min.) before
opening and use immediately after. The maximum stay at room
temperature after opening must not exceed 3 hours. After
removal from refrigerated storage, the unopened kit must be
used within 3 days.
The nasopharyngeal (or saliva) sample mixed with the abioMIX
reagent should be immediately loaded onto the COVID-19
capsule. The filled capsule should be immediately measured.
Traceability and calibration
Each lot of IVD CAPSULE COVID-19-NP is calibrated by the
manufacturer using a purified preparation of recombinant
2019nCoV antigen nucleocapsid protein (N protein) based on
the mass (concentration) of the analyte present in an artificial
matrix simulating nasopharyngeal secretion and saliva in order
to guarantee the diagnostic performance.
Quality control
The abioSCOPE evaluates internal controls at power-on and
after insertion of the capsule. If controls fail the abioSCOPE
displays a specific error message.
For external positive control material, it is recommended to use
SARS-CoV-2 Culture Fluid (UV Inactivated Hong
Kong/VM20001061/2020, 0810590UV) from ZeptoMetrix
Corporation mixed into a negative SARS-CoV-2 saliva pool or
artificial nasopharyngeal matrix. Contact the manufacturer for
assistance and follow the applicable local regulations and
guidelines.
The control intervals should be adapted to individual
requirements. The negative sample shall report a negative test
result. The positive sample shall report a positive test result.
Warnings and precautions
• For in vitro diagnostic use.
• The IVD CAPSULE COVID-19-NP must be kept
refrigerated until use.
• Do not freeze.
• Make sure that all packaging is intact. Do not use the test
if the bister packaging is visibly damaged.
• Allow the abioMIX reagent tube to reach room
temperature before use.
• Use only the swabs specifically provided with/for the kit.
• This product requires the handling of human specimens. It
is recommended that all human-sourced material should
be considered potentially infectious. Appropriate
precautions should be used for handling and disposal of
materials during and after testing.
• Do not use reagents after the expiration date printed on
the box.
• Incubation of the specimen in the abioMIX for more than
5 minutes may impact test results.
• This product is intended for use with nasopharyngeal and
saliva samples only.
• Clean the abioSCOPE surfaces regularly with alcohol (at
least before switching it on and after switching it off, as well
as in-between consecutive tests when appropriate).
Reagent deterioration
The following observations indicate reagent deterioration:
• Presence of turbidity in the abioMIX vial.
• Consistently positive or negative values from assay kits
from the same batch.