Development, validation, and implementation of a saline gargle test for COVID-19 in Botswana

BC was one of the first jurisdictions in the world to implement a saline rinse-gargle (“saline gargle”) collection method for COVID-19 testing, arising out the need to implement a nasopharyngeal (NP) swab-independent method to test for for COVID-19. Over extensive literature reviews, brainstorming, and discussions, saline gargle evolved to be a highly possible swab-independent option. Laboratory testing of PCR performance, stability, and appropriateness of the saline gargle was evaluated. Saline gargle performed well compared to the standard nasopharyngeal swab and viral transport media system.

Following the analytical validation of the sample type, a clinical validation was led by BC Children’s Hospital, which required volunteers to provide matched NP swabs, saline gargle, and saliva specimens for parallel testing. The clinical validation demonstrated that interpretation of nucleic acid test results were equivalent for the NP swab and saline gargle, while saliva was shown to have lower clinical sensitivity, particularly for pediatric patients. As part of the clinical validation findings, participants ranked saline gargle collection as the preferred collection method, adding to the rationale for selecting it as a testing option. A collaborative province-wide cross-validation study involving all COVID-19 testing laboratories across the province confirmed that saline gargle specimens were compatible with all COVID-19 nucleic acid-based testing platforms present in BC. 

Provincial Laboratory Medicine Services recommended the adoption of saline gargle for school-aged children and youth across BC, and provincial implementation started on 17 September, 2020, with representatives from laboratories, BC Children’s Hospital, BCCDC, public health, COVID collection centres, and PHSA Supply Chain created written collection instructions and an accompanying collection video, updated guidance documents, trained front-line staff, and sourced supplies. In November 2020, the approach was made available to adults.

Funded by a Centre for International Child Health (CICH) Seed Grant in 2020, this project has catalyzed new research directions, including exploring innovative diagnostic processes and pathogen genetic sequencing. This project is supporting exciting research led by Botswanan investigators into the performance of direct PCR molecular testing of SG samples to reduce steps in laboratory workflow, Next-Generation Sequencing of SG samples for COVID-19 variants, and metagenomics for other respiratory viruses. Furthermore, the project has resulted in Masters degrees for a trainee in Canada and a trainee in Botswana.

Publications and presentations:

Kayda I, Lechiile K, Kinshella MW, Bone J, Mulale U, Mosepele M, Strysko J, Dittrick M, Mokomane M, Goldfarb D. Sensitivity of gargle samples compared to swabs for SARS-CoV-2 detection with nucleic acid amplification testing: a systematic review and meta-analysis. In progress. 

Lechiile K, Kinshella MW, Kayda I, Mulale U, Strysko J, Dittrick M, Mosepele M, Moyo S, Mokomane M, Goldfarb D. Evaluation of the Saline Gargle Collection Method for the Molecular Detection and Sequencing of SARS-CoV-2 in Botswana. In progress.

Kayda I, Lechiile K, Kinshella MW, Bone J, Goldfarb D. Sensitivity of gargle samples compared to swabs for SARS-CoV-2 detection with nucleic acid amplification testing. PROSPERO 2022 CRD42022312628 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022312628

Kinshella MW, Lechiile K, Mokomane M, Goldfarb D. Saline gargle collection method for COVID-19 testing in Botswana. Infographic, policy brief and adaptation of parent and health worker information sheets for Botswana Ministry of Health and Princess Marina Hospital officials. 

Lechiile K, Kinshella MW, Strysko J, Mokomane M, Goldfarb D. Saline Gargle Sample Collection for COVID-19 Testing in Botswana. Stakeholders presentation at Princess Marina Hospital Department of Pediatrics Rounds; 2023 Jul 20; Gabarone, Botswana.

Lechiile K, Kinshella MW, Kayda I, Moyo S, Mokomane M, Goldfarb D. Evaluation of the Saline Gargle Collection Method for the Molecular Detection and Sequencing of SARS-CoV-2 in Botswana. Presented at: 11th EDCPT Forum - Partnering for Global Health Research Innovation and Impact in Africa; 2023 Nov 7-10; Paris, France

Kinshella MW, Lechiile K, Strysko J, Mokomane M, Goldfarb D. Saline Gargle Sample Collection for COVID-19 Testing in Botswana. Presented at: The Institute for Global Health and Healthy Starts Global Health Seed Grant Lunch and Learn; 2023 Jun 16; Vancouver, Canada. 

Kayda I, Lechiile K, Kinshella MW, Bone J, Goldfarb D. Sensitivity of gargle samples compared to swabs for SARS-CoV-2 detection with nucleic acid amplification testing: a systematic review and meta-analysis. Presented at: 2023 UBC Department of Medicine & Experimental Medicine Research Expo; 2023 Jun 2; Vancouver, Canada

Kayda I, Lechiile K, Kinshella MW, Bone J, Goldfarb D. Sensitivity of gargle samples compared to swabs for SARS-CoV-2 detection with nucleic acid amplification testing: a systematic review and meta-analysis. Poster session presented at: Healthy Starts Research Day; 2023 Feb 2; Vancouver, Canada

 


First Nations land acknowledegement

Action on Sepsis operates on the traditional, ancestral, and unceded territory of the Coast Salish peoples — xʷməθkʷəy̓əm (Musqueam), Sḵwx̱wú7mesh (Squamish), and Səl̓ílwətaʔ/Selilwitulh (Tsleil-Waututh) Nations. We invite everyone to reflect on the traditional territories and land that they currently work and live on.


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