Studies & Country
Number of participants
Sample timing
POC sample type
POC device/Method
Reference method/ platform
Control of Pre-analytical factors*
Method Agreement statistics GDM Diagnosis Criteria
Diagnostic performance Statistics
Conclusion
O’Malley EG (30)et al. Ireland
202
0-h 1h 2-h
CBG
Bayer Contour XT meter/Gluocse dehydrigenase
Beckman Coulter AU640 ( hexokinase)
Yes
Correlation R >0.9. Linear Regression: 0-h lab-VPG= 0.893 + (0.877 × 0-h POC) 2-h Lab-VPG = −0.352 + (1.031 × 2-h POC)
IADPSG diagnostic criteria
Sensitivity= 80.4% specificity= 86.4% PPV=88.2% NPV =77.6% Accuracy= 83%
where measures to inhibit glycolysis are implemented, the use of POC measurements for the diagnosis of GDM is not justified
Van den Berg et al. Netherlands (32)
80
0-h 2-h
CBG
Roche Accuchek Inform II/ glucose dehydrogenase
Not mentioned
Yes for 30 participants
Demming regression best fit 1.03 for 0-minute and 0.9 for 120 -minute (Bias0.06 mM versus 0.90 mM at 0 and 120, respectively,
WHO 1991
sensitivity: 100%, specificity: 98% FPR :2%
POC is valid alternative for Lab analysis
Daly et al. Ireland(20)
108
0-h 1-h 2-h
CBG
Bayer CONTOUR® XT Meter.
Beckman Coulter AU640 ( hexokinase)
Yes
*Correlation R=0.8 fasting R=0.85 1-hour R=0.91 2-hour
0-h: adjusted to ≥4.8 mol/l from 5.1mmol/l) 1-h:10.0 mmol/l and 2-h: 8.5 mmol/l
Sensitivity:92.5% Specificity:76.% PPV: 69.8%, NPV: 94.5% Accuracy: 94.5%,
POC-CBG was superior to customary laboratory practices
Balaji, V., et al.(26)
500
2-h
CBG
One touch Select Simple/ Oxidase
Hitachi aqua (Oxidase-Peroxidase)
No
Correlation R=0.907 Linear regression equation VPG=0.968x+CBG
2-h≥7.8 mmol/l for
Sensitivity: 93.8% Specificity: 97.4% FPR:2.6% FNR:6.2% ROC:0.993
Recommend for use where laboratory technology is not available
Gallardo et al. Mexico (33)
328
0-h
CBG (172 Measures) VBG (156 measures)
ACCU-CHEK instant® Glucose dehydrogenase
Not mentioned
No
POC-CBG R =0.4 at fasting, R≥0.5 at 1,2-hour POC-VPG R=0.6 at fasting, R >0.9 at 1,2 hour
ADA 2020
POC-CBG Sensitivity: 78.5% Specificity: 74.1 % POC-VB Sensitivity: 100% Specificity :62%
Proposes POC venous rather than capillary measurement as diagnostic alternative for low resource settings
Krinstein et al. Sweden (34)
135
0-h 1-h 2-h
VPG
HemoCue Glucose 201+ . HemoCue Glucose 201RT modified glucose dehydrogenas
ID-MS as reference and routine lab Cobas 8000 er (Roche) ( Hexokinase) as comparator
Yes
R=0.87 at 0-h R=0.95 at 1-h R=0.97 at 2-h HC201RT bias: −1.8) HC201+ Bias: +4.2% Routine lab bias+6.1%
WHO 2013
Not mentioned
Showed better performance of HC201RT than Comparator method and HC201+ in GDM diagnosis.
Landberg et al. Sweden (35)
175
0-h 1-h 2-h
VPG
AccuChek Inform II (glucose dehydrogenase)
EQA using ID/MS as a ref and Local Cobas c701 (hexokinase ) as comparator
Yes
R=0.98 Between POC and Comparator lab method. Cobas c701 has higher positive bias than POC when compared with EQA
WHO 2013
Not mentioned
Cobas c701 showed a large bias both towards Accu-Chek Inform II and the reference method used in the external control program,
Adam and Rheeder. South Africa(31)
594
0-h 1-h 2-h
CBG
Roche Accuchek Activ (hexokinase)
Beckman DXc (hexokinase)
Yes
Bland Altman showed bias +0.3 mmol/l at 0-h, negative bias -0.68 mmol/l at 1-h, -0.45 mmol/l at 2-hr
FIGO
Sensitivity: 27.0% specificity: 89.4% Accuracy: 72.8%
Roche Accuchek Active glucometer for the diagnosis of GDM cannot be recommended
Bhavadharini, Mahalakshmi et al. India(23)
1031
0-h 1-h 2-h
CBG
(One Touch Ultra-II, LifeScan) (oxidase)
AU2700 Beckman, Fullerton, CA (hexokinase)
No
R for fasting =0.43 R for 1-hour=0.65 R for 2-hour=0.74 Bias 0-h: minimal 1-h: 1mmol/l 2-h:1.1 mmol/l
2 analyses based on *IADPSG or *2-hour 6.1 or 6.6 mmol/l
2-h IADPSG Sensitivity: 62.3% Specificity 80.7%. 2-hour 6.1 mmol/l cut-off Sensitivity: 92.5 %
CBG can be used as an initial screening test for GDM, using lower 2H CBG cut points to maximize the sensitivity
Balaji, Madhuri et al.India(25) 819 2-h CBG Accu-Chek®(dehydrogenase) Hitachi aqua (Oxidase-Peroxidase) No linear regression VPG=0+0.974×CBG DIPSI =>7.8 mmol/l for 2-hours Sensitivity: 80.2%= specificity: 98.5% FPR: 19.8% FNR:1.5% AUC:0.991 CBG at a 2-h of ≥7.8 mmol/L may be recommended for GDM diagnosis in low resources setting
Garcia et al. Spain(24)
109
0-h 1-h 2-h 3-h
CBG
Accu-Chek (Dehydrogenase) (57 participants ) Contour Next (dehydrogenase) (52 participants )
AU5800-Beckman Coulter (Hexokinase)
No
Accu-Chek R ≥ 0.70 0-h bias: +0.15 2-h bias: +1 Contour Next R ≥ 0.75 0-h bias: -0.19 2-h bias: +1.49
NDDG
Accu-Chek FP(n):3 FN(n): 1 Contour Next FP(n): 9 FN(n):1
POCT can be used to obtain fasting values and reduce overall waiting times for patients.
Hossain et al. Pakistan (27) 1030 2-h CBG Accu-check (dehydrogenase) Dimension (Oxidase-Peroxidase) No R= 0.76 (DIPSI),2-hr ≥ 7.8 mmo/l Sensitivity: 94.8% Specificity: 79% PPV: 27.1 % NPV: 99.4 % ROC: 0.93 Non fasting CBG is useful for screening of abnormal glucose homeostasis in pregnancy.
Afzal et al. Pakisatn(28) 713 0-h CBG On Call EZ II (Oxidase) Roche c501 (hexokinase) No R=0.9 Linear regression CBG-POC=0.922 Lab-VPG + 1.055 1 0-h ≥ 5.1 mmol/l ADA Sensitivity: 96.9%, specificity: 78.2%, PPV :17.7%, NPV: 99.8% Fasting CBG recommended for screening of GDM at health care centres where automated analysers are not available
Jadhav et al. India (29) 1000 2-h CBG Not mentioned Not mentioned No Not mentioned DIPSI),2-hr ≥ 7.8 mmol/L Sensitivity: 100% specificity 99.4% It is appropriate to offer CBG sampling by DIPSI test for diagnosis of GDM
Elkheir et al. Egypt (36) 500 2-h CBG Accu-Chek Active (Dehydrogenase) Oxidase-peroxidase method No R=0.92 DIPSI),2-hr ≥ 7.8 mmol/L Sensitivity: 90.9% Specificity: 96.6% PPV:76.9% NPV: 98.8% ROC:0.99 CBG is an appropriate test for the GDM diagnosis in developing countries