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Table 4 Diagnostic accuracy results

From: Targeted antenatal anti-D prophylaxis for RhD-negative pregnant women: a systematic review

Study

n

TP

FN

FP

TN

Inconclusive results (%)a, b

Sensitivity in % [95% CI]b

Specificity in % [95% CI]b

De Haas 2016

25,789

15,816

9

225

9739

0 (0)c

99.9 [99.9; 100]

97.7 [97.4; 98.0]

Clausen 2014

12,668

7636

11

41

4706

274 (2.2)

99.9 [99.7; 99.9]

99.1 [98.8; 99.4]

Haimila 2017

10,814

7080

1

7

3640

86 (0.80)

100 [99.9; 100]

99.8 [99.6; 99.9]

Wikman 2012

3652

2236

55

15

1331

15b (0.4)

97.6 [96.9; 98.2]

98.9 [98.2; 99.4]

Chitty 2014

956d

535

1

4

341

75 (7.8)

99.8 [99.0; 100]

98.8 [97.1; 99.7]

 

2288e

2563

19

18

1920

393 (17.2)

99.3 [98.9; 99.6]

99.1 [98.5; 99.4]

Finning 2008

1869

1118

3

14

670

64 (3.4)

99.7 [99.2; 99.9]

98.0 [96.6; 98.9]

Müller 2008

1022

       

 “Spin column”f

 

660b

2b

3b

357b

0 (0)b

99.7 [98.9; 100]

99.2 [97.6; 99.8]

 “Magnetic tips”f

 

661b

1b

7b

353b

0 (0)b

99.8 [99.2; 100]

98.1 [96.0; 99.2]

Macher 2012

1012

619

0

7

386

0 (0)

100 [99.4; 100]

98.2 [96.4; 99.3]

Hyland 2017

599

370

0

1

226

2 (0.3)b

100 [99.0; 100]

99.6 [97.6; 100]

Akolekar 2011

586

332

6

0

164

84 (14.3)

98.2 [96.2; 99.3]

100 [97.8; 100]

Minon 2008

545

360

0

0

185

0 (0)

100 [99.0; 100]

100 [98.0; 100]

Soothill 2015

499

267

0

1

170

61g (12.2)

100 [98.6; 100]

99.4 [96.8; 100]

 

pooled estimateh

99.9 [99.5; 100]

99.2 [98.5; 99.5]

  1. a: Proportion of study participants with inconclusive results
  2. b: IQWiG’s own calculation
  3. c: 0.21% of samples were inconclusive (women with RhD variants). In this study these samples were categorized by the positive samples
  4. d: Results of the largest cohort of this study (11 to 13 weeks’ gestation). These results are included in the pooled effect
  5. e: Summarized data for 2288 evaluated women with a total of 4913 data sets including up to 4 measurement points (multiple measurements). The number of blood samples is therefore shown here
  6. f: “Spin column” and “magnetic tips” are two different methods for the extraction of cff-DNA from plasma samples. The patients with samples extracted by the spin column method are included in the pooled effect
  7. g: Treated like positive samples
  8. h: Generalized linear model to take into account the dependency between sensitivity and specificity
  9. cff: cell-free fetal; FN: false negative; FP: false positive; CI: confidence interval; n: number of evaluated participants; RHD: rhesus factor; TN: true negative; TP: true positive