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Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
– Instructions for use
Test Principle
Vivalytic SARS-CoV-2 DT, Flu A/B, RSV is a qualitative real-time PCR based
test utilizing reverse transcription (RT).
Storage und Usage Conditions
Product is stable until the expiry date if stored at + 15 °C to + 25 °C. Storage
and usage conditions can be taken either from the cartridge, pouch, or box
label. Cartridge has to be used at + 15 °C to + 25 °C, relative humidity < 65 %,
within 15 min upon pouch opening. This maintains hygiene and avoids perfor-
mance loss due to humidity. Prolonged exposure to humidity has a negative
impact on test performance.
Reagents
All reagents necessary for sample processing are integrated into the cartridge.
The processing includes cell lysis, nucleic acid extraction, reverse transcrip-
tion, DNA amplification, and detection.
Reagents are PCR bead, binding buffer, washing buffer and elution buffer. The
PCR bead contains the Reverse Transcriptase and Taq Polymerase enzymes.
Binding buffer facilitates binding of nucleic acids during the purification process.
Washing buffer is a formulation of different salts and solvents to remove impuri-
ties e. g. proteins during the extraction process. Elution buffer is a low-salt buf-
fer and contains the purified nucleic acids at the end of the extraction process.
Sample Type/Medium
The test is intended for use with nasopharyngeal swab samples in eNAT®
medium (FLOQSwabs® flexible Ref. 553C, eNAT® transport medium Ref.
608C, COPAN Italia S.P.A.), oropharyngeal swab samples or "lolly"-saliva
swab samples in eNAT® medium (FLOQSwabs® regular Ref. 552C, eNAT®
transport medium Ref. 608C, COPAN Italia S.P.A.). Collect and store sam-
ples as indicated in the manufacturer's instructions.
Sample Preparation
Nasopharyngeal/Oropharyngeal Swabs*
Avoid eating, drinking, smoking, and chewing gum 30 minutes before oropha-
ryngeal swab sample collection.
Use a COPAN FLOQSwabs® flexible swab for collection of nasopharyngeal
swab samples and a COPAN FLOQSwabs® regular swab for the collection
of oropharyngeal swab samples. Each swab is transferred into 1 ml eNAT®
transport medium. Break the swab and close the tube. Shake the sample
tube containing the swab sample in eNAT® medium for homogenization (avoid
foaming). Fill 300 μl of homogenized patient sample in the sample input of
the cartridge and close the cartridge lid. Insert the cartridge into the Vivalytic
one analyser.
Saliva "Lolly" Swabs*
Avoid eating, drinking, smoking, and chewing gum 30 minutes before sample
collection. Use a COPAN FLOQSwab® regular swab in dry tube. Carefully
remove the swab out of the dry tube. Avoid touching the outer surface of the
tube. Slightly press the swab against the palate using the tongue. Rotate the
swab for at least 30 seconds in this position and put the swab back into the
dry tube. Transport and process the saliva samples in a dry environment
(relative humidity < 65 %) and at room temperature (15 – 25 °C) within 4 h
to avoid sample degradation. Transfer the saliva swab samples into a 1 ml
COPAN eNAT® tube. Rotate the swab in the eNAT® medium at the inner sur-
face of the tube for at least 15 seconds to ensure the sample is released into
the eNAT® medium. Dispose the swab afterwards. Shake the tube thoroughly
but avoid foaming.
Fill 300 μl of homogenized patient sample in the sample input of the cartridge
and close the cartridge lid. Insert the cartridge into the Vivalytic one analyser.
*Do not use viscous samples that are difficult to pipette.
Test Result
The test result (list of positively/negatively detected targets) is shown on the
screen. The sample is classified either as positive, negative, or invalid. For
SARS-CoV-2, Flu A, Flu B and RSV one target is detected in each case. RSV A
and RSV B cannot be differentiated from each other.
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