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Newsletter | Covid-19

South African Health Products Regulatory Authority (SAHPRA)

Reading Time 2 minute read

On 20 April 2020 SAHPRA released a communication document to Stakeholders with information on requirements for Serological test kits.

SAHPRA confirmed that it has adopted only the specification criteria for serology/antibody point of care test (POCT) of the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK.

The specifications provided are the minimally (and some preferred options) clinically acceptable specifications for POCT tests to be made and/or used in South Africa during the COVID-19 pandemic.

The clinical requirements are based on the consensus of what is “minimally acceptable” performance in the opinion of the South African IVD industry, healthcare professionals and medical device regulators in light of the current emergency situation.

The Specification criteria for serology/antibody POCT tests include:

  1. Preferred product profile
  2. Target Population
  3. Target user setting
  4. Clinical sensitivity
  5. Clinical specificity
  6. Analytical specificity
  7. Sample type
  8. Available pack size
  9. Test format
  10. Test accessories
  11. Regulatory status

Criteria for Test procedure:

  1. Number of steps to be performed by operator
  2. Need for operator to transfer a precise volume or sample or reagents
  3. Requirements to add reagents
  4. Biosafety
  5. Need for operator to transfer a precise volume or sample
  6. Time to result
  7. Internal control
  8. Sample preparation
  9. Invalid rate

Operational characteristics specification criteria include:

  1. Operating conditions
  2. Reagent storage
  3. In use stability
  4. Reagents reconstruction
  5. End point stability
  6. Reader to reader variation
  7. Volume of sample
  8. Disposal requirements
  9. Kit presentation
  10. Training needs
  11. Power requirements
  12. Need for calibration/ training/spare parts
  13. Instructions for use
  14. Manufacturing environment
  15. Lead time for production

Clinical sensitivity includes confirmation tests which could be a molecular PCR test for SARS-CoV-2 virus using a validated laboratory test on nasopharyngeal specimens.

Analytical specificity relates to the assessment of cross reactivity with other pathogens (pre-pandemic samples, other coronavirus, SARS-CoV-1, EBV, RF) and a list of examples of high priority organisms likely in the circulating area are included in this specification document.

For more information on the Specifications for Serological Test Kits read the full Communication document here.


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