Table 3.
Characteristics and risk of bias of the included studies.
| Author (year) | Population/Setting | Sample size | Age | Dipstick that assessed ACR |
Reference test (ACR) |
Funding received | Risk of bias |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brand (Manufacturer) | Result | Lecture | Type of urine specimen | Type of urine specimen | Patient selection | Index test | Reference standard | Flow and timing | |||||
| Parsons 1999 (UK) [29] | Diabetic and/or kidney failure patients/outpatient | 144 | Not defined | Clinitek (Bayer plc, Newbury) | Colors | Automatic | Random | Random | Industry | High | Unclear | High | Unclear |
| Croal 2001 (UK) [27] | Diabetic patients/outpatient | 252 | Not defined | Clinitek 50 (Bayer Diagnostics, Tarrytown, USA) | Not defined | Automatic | Early morning | Early morning | Government | High | Unclear | High | Unclear |
| Graziani 2009 (Italy) [30] | General population and diabetic patients/primary care | 460 | Not defined | Clinitek Microalbumin (Siemens Medical Solutions Diagnostics, Mishawaka, IN, USA) | Colors | Automatic | Early morning | Early morning | Industry | Low | Unclear | High | Low |
| Lloyd 2011 (South Africa) [31] | Diabetic Patients/outpatient | 204 | Not defined | Clinitek® (Siemens® Medical Solutions Diagnostics, formerly Bayer) | Not defined | Automatic | Not defined | Not defined | Industry | High | High | High | Low |
| Nagrebetsky 2013 (UK) [28] | Diabetic patients/outpatient | 87 | Mean: 68 yr | Microalbustix (Siemens Healthcare Diagnostics Ltd, Frimley, UK) | Colors | Manual | Early morning | Early morning | Government | High | Low | High | High |
| McTaggart 2012 (UK) [35] | Patients with or at risk of CKD/primary care | 619 | Mean: 66.5 yr | Clinitek Microalbumin 9 reagent strips (Siemens Medical Solutions Diagnostics) | Trace and + | Automatic | Random | Random | Industry | High | Low | High | Low |
| Cho 2014 (Korea) [22] | Not defined/not defined | 1,040 | Not defined | URiSCAN Super cassette ACR (YD Diagnostics Corp., Korea) | Trace and + | Automatic | Random | Random | Not mentioned | Unclear | Unclear | High | Low |
| Park 2017 (Korea) [25] | General population/National Survey | 20,759 | Mean: 46.6 yr | Urisys 2400 cassette strip (Roche, Mannheim, Germany) | Trace and + | Automatic | Random (early morning if possible) | Random (early morning if possible) | Government | Low | Unclear | High | High |
| Nah 2017 (Korea) [24] | Prediabetic (preDM) and diabetic (DM) patients/primary care | 501 | Median: 60 yr (preDM); 64 yr (DM) | Clinitek Microalbumin 2 reagent strips (Siemens, New York, NY, USA) | Colors | Automatic | Early morning | Early morning | Not mentioned | High | Unclear | High | Low |
| Lim 2018 (Korea) [26] | Not defined/not defined | 1,020 | Not defined | URiSCAN 2 ACR Strip (YD diagnostics, Yongin, Korea) and CLINITEK Microalbumin 2 Strip (Siemens, New York, NY, USA) | Trace and + | Automatic | Random | Random | Government | Unclear | Unclear | High | High |
| Shiwa 2018 (Japan) [32] | Diabetic patients/outpatient | 291 | Mean: 64.3 yr | Uropaper αIII (Eiken; Eiken Chemical, Tokyo, Japan) | Trace and + | Automatic | Random | Random | Not mentioned | High | Unclear | High | Low |
| Salinas 2018 (Spain) [33] | Not defined/primary care | 9,148 | Mean: 63 yr | Brand not defined (Sysmex, Kobe, Japan) | Not defined | Automatic | Not defined | Not defined | Not funded | High | Unclear | High | Unclear |
| Kim 2020 (Korea) [23] | Diabetic patients/outpatient | 1,881 (development cohort); 431 (validation cohort) | Median: 66 yr (development cohort); 63 yr (validation cohort) | URiSCAN 2ACR strip (YD-Diagnostics Co., Yongin, Korea) | Colors | Automatic | Random | Random | Government | High | Unclear | High | Low |
| Yang 2020 (China) [34] | Not defined/not defined | 1029 | Not defined | Siemens Novus with Pro12 dipsticks (Amesdata Biotech Co.) | Not defined | Automatic | Random | Random | Not mentioned | Unclear | Unclear | High | Low |
ACR: albumin-creatinine ratio; CKD: chronic kidney disease; preDM: prediabetes mellitus; DM: diabetes mellitus; yr: years; UK: the United Kingdom; +: expressed as 1+/2+/3+/4 + according to cutoff value.