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Author/Date


Inclusion/exclusion criteria: i.e. presenting symptoms, results from previous tests

Inclusion: Exclusion:

Sample size


Participant demographics  (i.e. age, sex, spectrum of presenting symptoms, comorbidity, current treatments, recruitment centres)


Study methodology ( consecutive or random;

retrospective or prospective)


Period that study was carried out (beginning and end date)


Index test description (including criteria for positive test)


Reference test description (including criteria for positive test)


Geographical location of data collection


Setting of data collection


Persons executing and interpreting index tests

(numbers, training, and expertise)


Persons executing and interpreting reference test


Index/reference time interval (and treatments carried out in between)


Distribution of severity of disease in those with target condition


Other diagnoses in those without target condition


Adverse events from index test


Adverse events from reference test




Index test results

Threshold=

Condition positive

Condition negative

Total

Index test positive (T+)




Index test negative (T-)




Total