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 |