Investigating point of care diagnostic strategies to optimize the rapid diagnosis of COVID-19 in routine public and private health care settings in South Africa

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17785461

Enrollment

1581

Registered

2021-10-28

Start date

2020-10-01

Completion date

Unknown

Last updated

2021-11-08

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

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)

Interventions

1. Finger prick COVID-19 rapid test: We will prick participants and do a rapid test(s) using one or more kits for COVID-19. The rapid test result(s) can be given to participants, but it will not be pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years and older 2. Has symptoms of COVID-19 and meets current NICD/NHLS case definition for testing 3. Has been in close contact with a SARS-CoV-2 RT-PCR positive person (>15 minutes in a poorly ventilated space or =1 metre apart) and 4. Age 18 years and older and 5. Agrees to providing paired naso-pharyngeal and blood samples and 6. Self-reports not feeling sick or no symptoms of COVID-19 on initial questioning

Exclusion criteria

Exclusion criteria: Participant does not consent to follow-up including home based follow-up

Design outcomes

Primary

Measure	Time frame
Performance evaluation of Point Of Care tests is conducted by comparing field based SARS-CoV-2 rapid test results to gold standard laboratory based PCR results from accredited laboratories. Rapid tests and PCR are conducted at the baseline visit and 5 - 14 day follow up visit for persons under investigation	—

Secondary

Measure	Time frame
1. Cost effectiveness and ease of use data is collected via CRF administration at Baseline and 5-14 day follow up 2. Clinical symptoms data is collected via CRF at baseline and 5-14 day follow up and will be correlated to rapid and PCR test results 3. SARS-CoV-2 antibody efficiency/correlation is measured by conducting laboratory-based serology and neutralisation assays from blood samples collected at baseline and follow up 4. To compare rapid test results obtained against lab based formal serology platforms at baseline and 5-14 day follow up 5. Characterization of the viral genome of SARS-CoV-2 in infected participants will be conducted by performing lab-based sequencing assays from swab samples collected at baseline and follow up visits	—

Measure

Time frame

1. Cost effectiveness and ease of use data is collected via CRF administration at Baseline and 5-14 day follow up 2. Clinical symptoms data is collected via CRF at baseline and 5-14 day follow up and will be correlated to rapid and PCR test results 3. SARS-CoV-2 antibody efficiency/correlation is measured by conducting laboratory-based serology and neutralisation assays from blood samples collected at baseline and follow up 4. To compare rapid test results obtained against lab based formal serology platforms at baseline and 5-14 day follow up 5. Characterization of the viral genome of SARS-CoV-2 in infected participants will be conducted by performing lab-based sequencing assays from swab samples collected at baseline and follow up visits

—

Countries

South Africa

Outcome results

None listed

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