RecruitingACTRN12623000066684

Clinical Validation of ZiP-CoVx-P2 for COVID-19 point-of-care test in Ghana (VaZico Study Ghana)

Clinical Validation of ZiP-CoVx-P2 for COVID-19 point-of-care test in children and adults in Ghana (VaZico Study Ghana).

Sponsor

ZiP Diagnostics Pty Ltd

Enrollment

1,000 participants

Start Date

Oct 14, 2022

Study Type

Observational

Conditions

SARS-CoV-2 infection in respiratory samples COVID-19

Summary

Objective: To undertake clinical validation of a new point-of-care diagnostic test for SARS-CoV-2. Study Design: This is a multi-site prospective cross-sectional study seeking recruitment of 1000 study participant (adults and children) living around or visiting Hospitals and Community Health Clinics in Greater Accra and Central Regions of Ghana. Participants may be symptomatic or asymptomatic for respiratory symptoms. Study participants will provide two swabs. Each swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample. Optionally, saliva samples will be collected. Samples will be collected by the project field staff. All samples will be labelled with a participant ID number, date of collection and type of sample (throat & nasal swab) year of birth, but will not have any other identifying information. The samples will be used for validation of the ZiP-CoVx-P2 point-of-care molecular test platform to detect the presence of SARS-CoV-2 virus RNA. One swab sample will be used for the ZiP-CoVx-P2 test and the other swab will be used for gold-standard comparator test, laboratory-based RT-qPCR analysis and viral whole genome sequencing. This study will help to optimize and undertake clinical validation of the new ZiP-CoVx-P2 test, including estimates of test sensitivity and specificity. Outcome: This clinical validation study will include an analysis of test performance including sensitivity and specificity. The viral sequencing component of the project will help identify polymorphisms in the viral isolates that predispose an individual (symptomatic vs asymptomatic, male vs female) to variant-specific infections.

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

Fast, accurate COVID-19 testing remains important even as the acute phase of the pandemic has passed — particularly in lower-resource settings where laboratory-based testing is difficult to access. This study is validating a new point-of-care molecular test called ZiP-CoVx-P2, which can detect the SARS-CoV-2 virus quickly without needing a central laboratory, much like a rapid antigen test but using more sensitive molecular technology. The study is being conducted in Ghana, across hospitals and community health clinics in the Greater Accra and Central Regions. One thousand participants — both adults and children, with or without respiratory symptoms — will provide paired swab samples (throat and nasal). One swab will be tested with the new ZiP-CoVx-P2 device, and the other will be sent to a laboratory for the gold-standard PCR test. The results will be compared to establish how sensitive and specific the new test is. You are eligible regardless of age or whether you currently have any symptoms. There are no exclusion criteria — the study is welcoming anyone attending the participating health facilities who is willing to provide informed consent (or whose parent/guardian consents on their behalf). This kind of diagnostic validation work is important for ensuring that new tests perform reliably before being deployed at scale.

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Interventions

This is a multi-site prospective cross-sectional study seeking recruitment of 1000 study participants (adults and children) living around or visiting Hospitals and Community Health Clinics in Greater

This is a multi-site prospective cross-sectional study seeking recruitment of 1000 study participants (adults and children) living around or visiting Hospitals and Community Health Clinics in Greater Accra and Central Regions of Ghana. Participants may be symptomatic or asymptomatic for respiratory symptoms. Study participants will be asked to provide two swabs where the same clean swab will be used to take an oropharyngeal (throat) sample and then followed by a bilateral mid-turbinate (nasal) sample. Participants will be encouraged to provide a combined throat and nasal swab sample but will be given the option to provide a single sample type if they feel uncomfortable having the same swab being used to swab the throat and nose. Optionally, participants can also provide saliva samples. The samples will be collected by trained field staff following standard operating procedures (SOPs) in the study protocol. All field staff will report to the study coordinators, who will be responsible for all activities at the field sites. Of the two swabs collected per participant, one swab will be processed and tested on the ZiP-CoVx-P2 platform for the presence of SARS-CoV-2 virus RNA. The other will be used for RT-PCR (gold standard for SARS-CoV-2 detection). The ZiP-CoVx-P2 is an integrated cartridge-instrument platform that uses novel, low-cost nucleic acid amplification test (NAATs) technology. This test platform uses respiratory swabs and provides a test result within 30 minutes of sample collection. Testing on the ZiP-CoVx-P2 platform and with RT-PCR will be performed by trained research staff following the manufacturers’ instructions. All the Vazico team members including field and lab staff will be trained to perform the following: a. Reading the study protocol and participating in an education session on the associated study procedures. b. Reading the ZiP-CoVx-P2 Instructions for Use, and the ZiP-P2 instrument User Manual and practising the ZiP-CoVx-P2 point-of-care molecular test platform under supervision. c. Swab collection standard operating procedure (SOP) developed as outlined in the study protocol. All the field staff are trained to strictly adhere to the sample collection procedure as outlined. The study coordinators monitored field staff daily to ensure the field staff followed the proper procedures according to the study protocol.