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

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