Table 2.

Recommendations for problem areas in antinuclear antibody kit use and application

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