The CAR aims to implement a robust quality assurance programme for diagnosis of rickettsioses. This is because implementing a robust internal quality assurance (IQA) strategy and external quality assurance scheme (EQAS) will provide robust normalized data for understanding the burden of disease, devise interventions and channel available resources for prevention and control.
All the centres (hubs and spokes) which have been selected for training and those providing rickettsial diagnostics will be trained in IQA procedures.
IQA panels will be generated by the CAR and shared with the stakeholders/labs. Well defined positive controls and negative controls will be provided at the end of each training session to all participating labs. IQA panels will also be provided as needed. Further IQA programme implementation by participating labs will be monitored by site visits and direct observation. Testing of 10% samples or random 10, whichever is higher at the CAR will be performed to further assess the quality of diagnostics provided in the hub and spoke model established.
Note: Optimal implementation of IQA by the participants will provide robust normalized data for better prediction modelling.
EQAS Scheme
- This is a proficiency test (PT) scheme to assess the ability of the participants to provide reliable and accurate results.
- The PT scheme will have two cycles per year and three sets of samples for each parameter sent per cycle.
- Parameters assessed are serology and molecular assays.
- Serology: Sample is lyophilized serum, tests assessed: IFA, ELISA and ICT
- Molecular test EQAS: Matrix spike to ensure the quality of DNA extraction and PCR accuracy; lyophilized DNA for assessing PCR capability and accuracy.
- Sample preparation and assessment will be done as per ISO 17043, 2010 standard
The CAR being the reference centre will assign the values for the PT parameters. Against these values the zonal hubs and sub-centres value will be assessed. The in-house IFA developed by the CAR will be distributed within the network free of cost.
Note The CAR is already an ISO17043:2010 accredited PT provider for IAMM EQAS for Bacteriology & Serology. The PI is the Quality Manager for this. Hence, the CAR is well versed with technical requirements of providing a robust EQAS.