Epidemiological and ethical aspects of multiplex autoantibody testing.
Arrays are one of the technologies able to detect autoantibodies by measuring simultaneously many thousands of markers from a unique biological sample. The main purpose of a diagnostic test is making an early and accurate diagnosis. From a statistical point of view, multiple testing increases the probability of false positive and false negative results. Some correction methods are available to account for this problem for instance family-wise error rate or false discovery rate. From an ethical point of view, the decision to accept or decline a test not requested has to be made autonomously. Some people may seek clarification about tests and implications of their choices. A scarcity of proven measures to reduce mortality has to be considered too. Reasons may also include avoidance of psychological harm or anxiety. Moreover, protection of confidentiality and privacy has to be respected. In conclusion, the fact that testing is optional and that surveillance advice can be offered on the basis of risk alone without a test should be discussed in the consultation. The implication of a positive test result should be discussed to make a decision about the degree to which early treatment of the condition is better than late (or no) treatment.
Bidoli
Ettore
E
Biostatistics and Epidemiology Unit, Centro di Riferimento Oncologico, via Pedemontana Occidentale, 33081 Aviano (PN), Italy. epidemiology@cro.it
Villalta
Danilo
D
Battistin
M
M
Bidoli
E
E
Cammarota
A
A
Ciccone
M
M
Fedato
R
R
Lodi
B
B
Marchesini
F
F
Molaro
G
G
Ostardo
E
E
Rellini
G
G
Sartori
R
R
Schinella
D
D
D001323:Autoantibodies / Q000097:blood* / Q000276:immunology; D001327:Autoimmune Diseases / Q000175:diagnosis*; D003627:Data Interpretation, Statistical; D003951:Diagnostic Errors; D026690:Ethics, Clinical; D005189:False Positive Reactions; D006801:Humans; D011336:Probability; D040081:Protein Array Analysis; D012680:Sensitivity and Specificity
D001323:Autoantibodies