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Table 2 Recommendations for problem areas in antinuclear antibody kit use and application

From: The use and abuse of commercial kits used to detect autoantibodies

Principal Problem Recommendations
Manufacturer Variable reagents and analytes Standardized or common sources of reagents and analytes
  Variable secondary antibodies Standardized or common sources of secondary antibodies
  Premarketing, beta testing and selling kits Wider testing in clinical laboratories before marketing and selling
  Quality control and postmarketing surveillance Willingness and ability to adjust and to improve kit performance
Clinical laboratory Equipment Upgrading and use of equipment to standards
  Protocols and standard operating procedures Follow manufacturer's protocols
   Utilize international reference sera
   Utilize local sera from clinically defined and normal controls to assess performance of kit before adopting into practice
  Training and maintenance of competence Technologist required to demonstrate competence and to participate in appropriate educational forums
  Test requisitions and reports Should be clear and concise
   Provide clear algorithm of tests provided and approach to use (Fig. 2)
   Design and adopt a universal format
   Report graded positive results when appropriate or give clinically meaningful cutoff
  Physician liaison Staff with specific skills serve as primary physician liaison to provide advice and to assist with test interpretation
Physician Ordering tests Aware of clinical laboratory capabilities
   Utilize graded approach to ordering tests (Figure 2)
  Receiving tests In cooperation with ethics boards, move to digital or electronic receipt of test results while maintaining patient confidentiality
  Interpreting result If result not understood contact physician liaison at laboratory
  Communication of results Timely action after report received because diseases can progress rapidly
  Patient advocate and educator If appropriate, enquire about patient's willingness to participate in research
   Seek informed consent
Patient Accurate historian Possess and protect record of current medical history and record important symptoms
  Participation Consider participation in research studies
   Review and provide signed informed consent
   Allow serum to be used for research
Regulatory bodies Quality assurance Attention to quality of samples provided for ongoing quality assurance programs
   Utilize international standards and reference sera
Health care underwriters Budgeting Ensure that budget keeps pace with appropriate advances in serology
   Support the use of tests that have been proven to have an impact on patient care and outcome
  Alignment of services Ensure that laboratory services are optimized
   Consider impacts of laboratory consolidation on quality of care