Assessment of the Cow's Milk-related Symptom Score (CoMiSS) as a diagnostic tool for cow's milk protein allergy: a prospective, multicentre study in China (MOSAIC study).

The MOSAIC study aimed to evaluate if the Cow's Milk-related Symptom Score (CoMiSS) can be used as a stand-alone diagnostic tool for cow's milk protein allergy (CMPA). Single-blinded, prospective, multicentre diagnostic accuracy study. 10 paediatric centres in China. 300 non-breastfed infants (median age 16.1 weeks) with suspected CMPA. After performing the baseline CoMiSS, infants commenced a cow's milk protein elimination diet with amino acid-based formula for 14 days. CoMiSS was repeated at the end of the elimination trial. Infants then underwent an open oral food challenge (OFC) with cow's milk-based formula (CMF) in hospital. Infants who did not react during the OFC also completed a 14-day home challenge with CMF. A diagnosis of CMPA was made if acute or delayed reactions were reported. A logistic regression model for CoMiSS to predict CMPA was fitted and a receiver-operator characteristic (ROC) curve generated. An area under the curve (AUC) of ≥0.75 was deemed adequate to validate CoMiSS as a diagnostic tool (target sensitivity 80%-90% and specificity 60%-70%). Of 254 infants who commenced the OFC, 250 completed both challenges, and a diagnosis of CMPA made in 217 (85.4%). The median baseline CoMiSS in this group fell from 8 (IQR 5-10) to 5 (IQR 3-7) at visit 2 (p<0.000000001), with a median change of -3 (IQR -6 to -1). A baseline CoMiSS of ≥12 had a low sensitivity (20.3%), but high specificity (87.9%) and high positive predictive value (91.7%) for CMPA. The ROC analysis with an AUC of 0.67 fell short of the predefined primary endpoint. The present study did not support the use of CoMiSS as a stand-alone diagnostic tool for CMPA. Nevertheless, CoMiSS remains a clinically useful awareness tool to help identify infants with cow's milk-related symptoms. NCT03004729; Pre-results.

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Competing interests: YV has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Abbott Nutrition, Biogaia, Biocodex, Danone, Hero, Hipp, Johnson & Johnson, Mead Johnson, Merck, Menarini, Nestlé Nutrition Institute, Nutricia, Orafti, Pfizer, Phacobel, Sari Husada, Shire (Movetis), Sucampo, Takeda, United Pharmaceuticals, Wyeth and Yakult. CD has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Abbott Nutrition, Danone, Novalac, Nestlé Nutrition Institute, Nutricia, Sodilac, United Pharmaceuticals and Wyeth. PE has received lecture honoraria from Danone and Sodilac, and has received research grants from Nestlé. CR-K has participated as consultant and/or speaker for Mead Johnson International, Hero Institute, Alter-Nutriben, Danone and Nestlé. HS has participated as a clinical investigator and/or speaker for Ausnutria, Arla, Biogaia, Biocodex, Danone, Dicofarm, Else Nutrition, HiPP, Nestlé, Nestlé Nutrition Institute, Nutricia, Mead Johnson, Myor and Merck. KB has received lecture honoraria from Nestlé. SS has participated as a clinical investigator/, and/or advisory board member, and/or consultant, and/or speaker for Danone, Dicofarm, DVA, Nestlé and United Pharmaceuticals. RS has participated as clinical investigator, and/or advisory board member, and/or consultant and/or speaker for Abbott, Else, Nestlé Nutrition Institute, NGS and Nutricia. AJ and RGH are full-time employees of Nestlé Health Science. The other authors have disclosed no conflict of interest relevant to this article.