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SARS-CoV-2 Antigen RDT Country Readiness Checklist

Medium 18 items · 30 min
testuser's avatar
testuser Published 2 months ago

This checklist helps health program managers and facility leads quickly assess country readiness to roll out SARS-CoV-2 antigen rapid diagnostic tests. Use it to confirm regulatory, logistics, training, quality, and data systems are in place before wider implementation. Inspired by World Health Organization guidelines. Always consult a qualified healthcare professional.

Inspired by World Health Organization (WHO) guidelines. Always consult a qualified healthcare professional where applicable.

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  1. Confirm regulatory approval for selected antigen RDTs — Verify national authorization or WHO emergency listing for each test.
  2. Map national testing strategy and target groups — Define who will be tested, where testing occurs, and program goals.
  3. Develop standardized testing protocols and SOPs — Include eligibility, specimen steps, result interpretation, and reporting flow.
  4. Train healthcare and testing staff on procedures and safety — Provide hands-on practice, competency checks, and infection control training.
  5. Secure procurement and supply plan for kits and consumables — Document quantities, lead times, and backup suppliers for continuity.
  6. Verify storage, transport and inventory management processes — Follow manufacturer temperature ranges and track lot numbers.
  7. Set up safe specimen collection and biohazard waste handling — Plan sharps management, biohazard bags, and approved disposal routes.
  8. Ensure adequate PPE and infection-control measures at sites — Stock appropriate masks, gloves, eye protection, and hand hygiene supplies.
  9. Establish a data reporting and monitoring system
  10. Define required data fields and formats — Include patient ID, test type, result, date, and location.
  11. Set reporting frequency and assign responsibilities — Specify daily/weekly reporting cadence and responsible roles.
  12. Integrate quality assurance and external verification plan — Plan lot verification, periodic proficiency checks, and record keeping.
  13. Prepare risk communication and community engagement messages — Provide clear guidance on why to test, expected results, and next steps.
  14. Review legal, privacy and informed-consent procedures — Define consent steps, data privacy safeguards, and record retention rules.
  15. Establish technical support and manufacturer contact points — List hotlines, distributor contacts, and local lab resources.
  16. Run a small pilot at selected sites and evaluate workflow — Test the full process and collect feedback on bottlenecks and errors.
  17. Monitor test performance and report adverse events — Track invalid rates, false results, and product complaints for action.
  18. Document policies, training logs, and inventory records — Keep clear records to support audits, scale-up, and continuous improvement.
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