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. 2021 Feb 10;2021(2):CD010945. doi: 10.1002/14651858.CD010945.pub2

Schirinzi 2015.

Study characteristics
Patient Sampling Patients received lumbar puncture for diagnostic purposes at the Neurology unit of Policlinico Tor Vergata, Rome‐Italy between 2012 and 2014.
Patient characteristics and setting CSF samples from 28 participants: 14 ADD and 14 iNPH.
Sex: 6 males and 8 females for AD and 8 males and 6 females for iNPH
Age (SD) (y): 69.85 ± 7.42AD; 73.21 ± 4.63 for iNPH
Index tests Patients gave CSF samples. The samples were collected in polypropylene tubes, stored on ice and sent to local laboratory and analysed (within 1 hour).
Abeta42 was measured using enzyme‐linked immunosorbent assays, obtained from Innogenetics NV, Gent, Belgium.
Threshold: 371pg/mL, not pre‐specified, determined by ROC analysis.
Were the index test results reported without knowledge of the reference standard? Not reported
Target condition and reference standard(s) Target condition: Alzheimer's disease dementia (differential diagnosis of AD from idiopathic NPH)
Reference standards: NINCDS‐ADRDA criteria for AD.
Subjects received a diagnosis according to iNPH guideline criteria for possible iNPH.
It was not reported whether the results of the reference standard results were interpreted without knowledge of the results of the index test.
Flow and timing Clinical diagnosis and CSF sample collection was done on the same day.
Comparative  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? No    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Unclear risk  
Are there concerns that the included patients and setting do not match the review question?     Unclear
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Unclear    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Unclear risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Unclear
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk