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Table 3 Summary of 8 previous studies on the lower reference limit (LRL)/lower decision limit (LDL) of cord G6PD activity and our LRL/LDL estimations based on methods of those studies

From: Lower reference limits of quantitative cord glucose-6-phosphate dehydrogenase estimated from healthy term neonates according to the clinical and laboratory standards institute guidelines: a cross sectional retrospective study

Study

Mean (SD)aOR Mediana

P-valueb

LRL/LDLa

Our LRL/LDL estimationsabased on methods of previous studies

Method for LRL/LDL estimation

G6PD measurement method

I. Previous studies with means/medians similar statistically/clinically to those of the present study

Fok et al. (1985) [8]

  

10.6

10.8

Chinese neonates born at >30 weeks of gestation.

Cobas Bio,F.Hoffmann, La Roche & Co. (Switzerland)

Male (n = 660)

14.8

<.001c

  

Observed normal G6PD activity separated from abnormal activity in male neonates.

 

14.3 (3.9)

.30

  

Female (n = 568)

14.6

<.001c

  

The 3rd percentile of values

 
 

14.6 (2.9)

.002c

  

after excluding deficient male neonates (< 3.0).

 

Ainoon et al. (2003)[10] (n = 976)

14.6 (mean)

SD was not reportedC

8.7

8.5

Malay and Chinese neonates. Gestational age was not addressed. G6PD deficiency is < 60% of the normal mean level.

Randox Laboratories, Ltd.

Riskin et al. (2012) [15]

14.7 (2.0)

<.001c

  

Jew (Sephardic, Ashkenazi, Ethiopian), Arab (Muslim, Druze, Christian), and Caucasus preterm and term neonates.

Sentinel Diagnosticskit (Italy)

(n = 2269 term neonates)

      

Male

  

>7.0

8.5

G6PD deficiency is < 60% of the normal mean level. [70] Gender distribution. Hardy-Weinberg equation.

 

Female

  

>10.0

9.6

II. Previous studies with means lower than those of the present study

Boo et al. (1994) [7]

  

>4.1

9.9

Normal Malay, Chinese, and Indian neonates born at 37 weeks of gestation with

Manually according to the standardized

Male (n = 135)

8.3 (2.2)

<.001

  

G6PD level 4.1 U/g Hb or negative fluorescence spot test.

WHO method for G6PD assay of the hemolysate.

95% CI:7.9-8.6

<.001

    

Female (n = 127)

8.5 (2.1)

     
 

95% CI:8.2-8.9

   

Mean-2SD

 

Azma et al. (2010) [11] (n = 94)

12.4 (2.3)

<.001

10.2

12.0

Normal term Malay neonates with negative fluorescence spot test. 68% reference interval (mean-1SD)

OSMMR-D (R&D Diagnostics Ltd., Greece)

III. Previous studies with mean/median higher than those of the present study

Reclos et al.(2003) [9]

    

Uneventful pregnancies and normal full-term deliveries.

OSMMR200 0 (R&D

Greek Male (n = 505)

20.8 (1.6)

<.001

12.5

8.5

G6PD deficiency is < 60% of the normal mean level.[70]

Diagnostics Ltd., Greece)

Greek Female (n = 551)

19.5 (2.0)

<.001

11.7

8.5

  

Albanian Male (n = 444)

21.6 (2.0)

<.001

13.0

   

Albanian Female (n = 363)

21.0 (2.6)

<.001

12.6

   

Kaplan et al. (2005) [13]

    

Healthy term and near-term African American neonates.

Technicon RA 1000 analyzer (Bayer Diag.,NY)

Male (436)

21.8 (2.9)

<.001

14.5

9.1

Observed normal G6PD activity separated from abnormal activity in male neonates.

 

Algur et al. (2012) [16]

    

Sephardic Jew born at 36 weeks of gestation.

Sentinel Diagnostics kit (Italy)

Male (n = 1256)

18.8

<.001

9.0

9.1

Males: observed normal G6PD activity separated from abnormal activity.

 

Female (n = 1153)

18.4

<.001

9.5

7.1d

Probable normal females: > 50% of the normal male median level.

 
  1. aG6PD activity expressed as Units/gram Hemoglobin (U/g Hb). Some of the original values were rounded to one decimal.
  2. b P-value for the two-sample t-test that was used to compare our means with those of previous studies and the one-sample Wilcoxon signed rank test that was used to compare our medians with those of previous study.
  3. cNot clinically significant.
  4. dOur estimated LRL would be 9.6 U/g Hb based on the observed gap in G6PD values of females.
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BMC Pediatrics

ISSN: 1471-2431

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