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Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA

Evaluating the Use of Flavour-Stimulated Oral Fluids Collection for Severe Acute Respiratory Syndrome Coronavirus 2 Detection by Reverse Transcriptase Polymerase Chain Reaction and Enzyme Linked Immunosorbent Assay - a Concordance Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/03/031616
Enrollment
300
Registered
2021-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

None listed

Sponsors

Datar Cancer Genetics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Known COVID-19 positive by RTPCR (with active infection) OR Known COVID-19 negative by RTPCR (tested within 7 days) 2. Provision of Informed Consent 3. Willing to provide Nasopharyngeal Swab as well as Buccal Cavity Swab

Exclusion criteria

Exclusion criteria: 1. Pediatric patients. 2. Inability to provide Informed Consent. 3. Inability to provide Nasopharyngeal Swab and / or Buccal Cavity Swab. 4. Other conditions: allergic to latex. 5. Diagnosed with psychological conditions that restrict ability to comply with study procedures; 6. Prisoners and pregnant women 7. Subjects with pathologies relating to dental, oral and salivary conditions. 8. Subjects with allergies related to the components used in the kit. 9. Any other condition as judged by the PI which will restrict the ability to participate in the study and / or comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Concordance between COVID19 status as determined by buccal cavity swab and contemporary nasal swab, respectively.Timepoint: Baseline (Day 0)

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Vineet Datta MD FRCP

Datar Cancer Genetics

drvineetdatta@datarpgx.com00919911110457

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026