ClinicalTrials.gg
CompletedNCT05596032Updated May 3, 2023

Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2

An observational study in COVID-19 and COVID-19 Pandemic, sponsored by Abionic SA. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Abionic SA · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
440
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 392 studies in COVID-19 with a site in Italy — 37 open to participants now, 46 under way, 7 of them phase 3. COVID-19 · Italy.

Enrollment
88th of 238
440 · median 251
Started
2022
with 35 others
Observational
238 of 392
24 open now
Registered
328th of 392
by date

Among the 392 studies in COVID-19 with a site in Italy, this one is the 88th largest by enrollment of the 238 observational ones that give a count, is one of 36 that started in 2022, is one of 238 observational ones, and was the 328th registered.

COVID-19

7,993 studies on the registry are indexed under COVID-19; 467 are open to participants now.

Browse COVID-19 studies →

Open to participants now

37 of the 392 studies in COVID-19 with a site in Italy are open now. Recruiting first, the newest first:

32 more — sign in →

All 37 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 392 studies in COVID-19 with a site in Italy, or all of them as a file.
02

Study summary

The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument.

The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test:

  1. shows sensitivity:

    • ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or
    • ≥ 90% for subjects with Ct ≤ 25.
  2. show ≥ 98% specificity.
03

Conditions studied

  • COVID-19
  • COVID-19 Pandemic

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population includes unselected participants*, symptomatic, asymptomatic having had close contact with positive patients, and asymptomatic with no known exposure to SARS-CoV-2.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • provide valid before taking the tests;
  • in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms.
  • Male or female, aged equal to or older than 18 years of age.

Exclusion criteria

Exclusion Criteria:

  • Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
440 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test

    The purpose of this work is to carry out a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for the antigenic determination of the SARS-CoV-2 virus on the abioSCOPE instrument.

    Time frame: through study completion, an average of 1 month

07

Study locations

1 site
  • A.O Mauriziano di Torino
    Torino, 10126, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Jan 2023, 3 months.

Of 134 industry-sponsored observational studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 3 months is below that.

Counting every sponsor, half of 1,775 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2022
First posted
Oct 27, 2022
StartActual
Oct 23, 2022
Primary completionActual
Jan 27, 2023
CompletionActual
Feb 1, 2023
Last update
May 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05596032
Lead sponsor
Abionic SA
Responsible party
Sponsor
First posted
Oct 27, 2022
Start date
Oct 23, 2022
Primary completion
Jan 27, 2023
Completion
Feb 1, 2023
Last update
May 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion