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NCT05514691
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
NA trial testing iStatis COVID-19 Ag Rapid Test in COVID-19 Virus Infection in 129 participants. Completed in 27 January 2022.
21 January 2022
Quick facts
| Lead sponsor | bioLytical Laboratories |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 129 |
| Start date | 13 January 2022 |
| Primary completion | 21 January 2022 |
| Estimated completion | 27 January 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- iStatis COVID-19 Ag Rapid Test
- "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")
Conditions studied
- COVID-19 Virus Infection — all drugs for COVID-19 Virus Infection →
- COVID-19 — all drugs for COVID-19 →
- Coronavirus Disease-19 — all drugs for Coronavirus Disease-19 →
- COVID-19 Pandemic — all drugs for COVID-19 Pandemic →
Sponsor
bioLytical Laboratories
Who can join
18 and older, any sex, with COVID-19 Virus Infection or COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A rapid point of care test for the detection of virus particles will be compared to the FDA approved EUA RT-PCR detection standard. The iStatis COVID-19 Ag Rapid Test is intended for rapid point-of-care detection of the SARS-CoV-2 nucleocapsid protein antigen.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05514691
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other bioLytical Laboratories trials
Trials by the same sponsor.
- NCT07061912 — A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US · NA · completed
- NCT06368453 — A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test · NA · completed
- NCT06368466 — A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites · NA · completed
- NCT06368479 — Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings · NA · completed
- NCT06365606 — Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05514691 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by bioLytical Laboratories
- Last refreshed: 24 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05514691.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing