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
For nasopharyngeal specimen collection, take the
included nasopharyngeal swab, insert it through the
nostril along the nasal septum to the nasopharynx, until
resistance is felt. Gently roll the swab for several
seconds to collect the specimen and then slowly
withdraw the swab while rotating it.
For saliva specimen collection, take the saliva swab
(accessory REF P04.00019), insert it into the mouth and
place it under the tongue. Let the saliva passively pool
under the tongue and between tongue and cheek for
approximately 15 seconds. Soak the swab with the pooled
saliva by rolling and moving the swab under the tongue
from side-to-side 5 times and then withdraw the swab from
the mouth.
6. The sample should be processed immediately using the
IVD CAPSULE COVID-19-NP kit, and the whole
procedure should be executed within 5 min.
7. Take the extraction reagent tube and flick the tube in a
downwards motion to move all the reagent to the bottom
of the tube. Subsequently, remove and discard the cap
from the tube.
8. Carefully insert the swab into the extraction buffer in the
tube and stir the swab in the fluid against the tube wall for
a minimum of 10 seconds, taking care not to splash
contents out of the tube.
9. Remove the swab while squeezing the sides of the tube to
extract the liquid from the swab.
10. Press the dropper tip firmly onto the extraction reagent
tube containing the processed sample (twisting is not
required).
11. Adding drops to the test device
• Invert the extraction reagent tube and hold it vertically
(approximately half a centimetre above the sample
port).
• Gently squeeze the ridged body of the tube,
dispensing two (2) drops of the processed specimen
into the middle of the sample port, as displayed in the
image below.
• Fold the lid over to close the capsule. Hold the
capsule only by the edges. Be careful not to touch
the bottom side of the capsule.
• Excess volume that remains in the tube can be used
for retesting if necessary.
• Immediately (within 30 seconds) measure the
capsule in the abioSCOPE.
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