The NSW Newborn Screening Programme commenced screening of newborns for classical congenital adrenal hyperplasia (CAH) in May 2018. All newborns born in NSW and ACT are screened for CAH using a two-tier protocol, the first tier measuring 17α-hydroxyprogesterone (17αOHP) using immunoassay followed by second-tier steroid profiling via liquid chromatography-tandem mass spectrometry (LC-MS/MS) measuring 17αOHP (MS17αOHP), androstenedione, and cortisol 1, 2. This screening algorithm gave a CAH screening positive predictive value (PPV) of 71.4%3. There were 16 (from 388,416 screened) proven cases of CAH giving an incidence of 1:24,276
The CAH screening efficacy with the addition of 21 deoxycortisol to LC-MS/MS steroid profiling was investigated to determine if it is a better disease marker compared to 17αOHP for CAH. The top 98th centile of daily immunoassay 17αOHP measurement from June 2021-February 2022 were selected (n=2762).The positive predictive value (PPV) for 17αOHP and 21 deoxycortisol as a sole indicator and part of a ratio were calculated.
There was no statistically significant effect of birth weight or gestational age (GA) on 21 deoxycortisol compared to 17αOHP. The calculated PPV, using a 95th centile concentration cut-off, showed no significant improvement when comparing 21 deoxycortisol (10.9%), against MS17αOHP (11.5%), as a sole disease marker without birth weight and GA stratification.
By combining the use of MS17αOHP concentrations of 40.1 nmol/L whole blood (WB) and MS17αOHP+A4)/cortisol of 1.2, MS17αOHP/cortisol of 1.6, and (MS17αOHP+21 deoxycortisol)/cortisol of 1.9 all newborns with CAH with gestational age (GA) >259 days were correctly identified. Screening efficacy for newborns with GA <259 days improved when the cut-off MS17αOHP WB concentration of 58.2 nmol/L in combination with (MS17αOHP + 21 deoxycortisol)/cortisol of 3.4 was used.
This study showed that the screening efficacy improved with GA stratification. No significant statistical improvement was detected by using 21 deoxycortisol as a disease marker for CAH.