SARS-CoV-2 Antigen RDT Country Readiness Checklist

18 items · Health · Medium difficulty · 30 min

Quick country readiness checklist for SARS‑CoV‑2 antigen rapid tests.

• Confirm regulatory approval for selected antigen RDTs

  Verify national authorization or WHO emergency listing for each test.

• Map national testing strategy and target groups

  Define who will be tested, where testing occurs, and program goals.

• Develop standardized testing protocols and SOPs

  Include eligibility, specimen steps, result interpretation, and reporting flow.

• Train healthcare and testing staff on procedures and safety

  Provide hands-on practice, competency checks, and infection control training.

• Secure procurement and supply plan for kits and consumables

  Document quantities, lead times, and backup suppliers for continuity.

• Verify storage, transport and inventory management processes

  Follow manufacturer temperature ranges and track lot numbers.

• Set up safe specimen collection and biohazard waste handling

  Plan sharps management, biohazard bags, and approved disposal routes.

• Ensure adequate PPE and infection-control measures at sites

  Stock appropriate masks, gloves, eye protection, and hand hygiene supplies.

• Establish a data reporting and monitoring system
• Define required data fields and formats

  Include patient ID, test type, result, date, and location.

• Set reporting frequency and assign responsibilities

  Specify daily/weekly reporting cadence and responsible roles.

• Integrate quality assurance and external verification plan

  Plan lot verification, periodic proficiency checks, and record keeping.

• Prepare risk communication and community engagement messages

  Provide clear guidance on why to test, expected results, and next steps.

• Review legal, privacy and informed-consent procedures

  Define consent steps, data privacy safeguards, and record retention rules.

• Establish technical support and manufacturer contact points

  List hotlines, distributor contacts, and local lab resources.

• Run a small pilot at selected sites and evaluate workflow

  Test the full process and collect feedback on bottlenecks and errors.

• Monitor test performance and report adverse events

  Track invalid rates, false results, and product complaints for action.

• Document policies, training logs, and inventory records

  Keep clear records to support audits, scale-up, and continuous improvement.

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