abionic IVD CAPSULE COVID-19-NP User Manual
- June 3, 2024
- abionic
Table of Contents
abionic IVD CAPSULE COVID-19-NP
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
days1,2.
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
150l 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.
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
-
Allow the abioMIX reagent to warm up to room temperature (about 10 min) before opening and use immediately after.
-
The test subject shall not eat, drink or smoke for 30 min before the test.
-
It is recommended to put on protective gloves before starting the procedure.
-
Initiate the abioSCOPE analyser
- Make sure that the abioSCOPE is switched on and ready to measure.
-
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.
For nasopharyngeal specimen collection , take the included nasopharyngeal swab, and 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 the 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. -
The sample should be processed immediately using the IVD CAPSULE COVID-19-NP kit, and the whole procedure should be executed within 5 min.
-
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.
-
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.
-
Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
-
Press the dropper tip firmly onto the extraction reagent tube containing the processed sample (twisting is not required).
-
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.
-
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.
-
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.
-
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.
Limitations
- Eating, drinking, or smoking within 30 min before the test may adversely affect the test performance.
- Failure to correctly follow the test procedure may adversely affect the test performance and/or invalidate the test result.
- A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
- Positive test results do not rule out co-infections with other pathogens.
- Negative test results are not intended to rule out other viral or bacterial infections.
- Negative results should be treated as presumptive and confirmed with a molecular test if COVID-19 disease is suspected.
- The collected specimens should be tested as quickly as possible after collection.
- All assay materials are single-use and cannot be re-used.
- Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples.
- The amount of antigen in a sample may decrease as the duration of the illness increases. Specimens collected after day 5 of illness are more likely to be negative compared to an RT-PCR assay.
- Monoclonal antibodies may fail to detect or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region.
The user shall report any serious incident that has occurred in relation to the device to the manufacturer and the relevant national competent authority.
Performance characteristics
Analytical sensitivity
LoD was determined by spiking SARS-CoV-2 Culture Fluid UV Inactivated Hong
Kong/VM20001061/2020 (0810590UV, batch 326734, ZeptoMetrix Corporation) into a
negative SARS-CoV-2 saliva pool or artificial nasopharyngeal matrix. In the
first phase, a 10-fold dilution series, starting from a target concentration
of 105 TCID50/ml was performed. Each dilution was tested in 3 replicates on
bioscope 2.0. The lowest concentration to give 3 positive results was selected
to measure a 2-fold dilution series where each dilution is tested in 3
replicates on the bioscope 2.0. The lowest concentration to give 3 positive
results was 755 TCID50/mL. When tested in 20 replicates this dose gave 20 out
of 20 results. The limit of detection (LoD) within a 95% confidence interval
for IVD CAPSULE COVID-19-NP is 755 TCID50/mL.
Microbial interferences
The IVD CAPSULE COVID-19 assay was tested for cross-reactivity and
interference using bacteria and viruses that are reasonably likely to be
encountered in respiratory clinical specimens, and no cross-reactions nor
interferences were observed at the concentrations as listed below:
Analytical selectivity
No positive interference was observed with the following substances tested
at the indicated concentrations into SARS-CoV-2 negative sample:
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 2.12×107 TCID50/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:
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:
- 100.0% (CI95: 85.8% -100.0%) for Ct <25,
- 91.6% (CI95: 83.4% – 96.5%) for Ct<30,
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:
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:
- 100.0% (CI95: 73.5% – 100.0%) for Ct <25,
- 85.1% (CI95: 75.0% – 92.3%) for Ct<30,
- 69.2% (CI95: 59.5% – 77.7%) for Ct<35.
References
Date of issue of this document: May 05, 2022 (V1.2).
IVD CAPSULE, abioMIX, and bioscope are trademarks of Abionic. © 2022, Abionic SA
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