Table 6.
Characteristics of studies dealing with CoMiSS.
| Author (Year) |
Study Design | Number (Age) |
Cases with +ve IgE and/or SPT | CoMiSS vs. OFC | CoMiSS and Elimination Diet | Sensitivity/ Specificity PPV-NPV |
Author’s Conclusions |
|---|---|---|---|---|---|---|---|
| Vandenplas (2014) [131] |
Cohort | 116 (2 weeks– 6 months) |
sIgE>0.35 KU/L = 8% +ve SPT = 10% |
OFC in 85/116 (73%) +ve in 59 (69%) |
Basal score ≥12 If reduced to ≤6, 80% positivity of OFC. | ND | Score ≥12 useful for CMA diagnosis If reduction >50% with diet, high VPP for positive OFC |
| Chakrabarty (2017) [132] |
Prospective | 30 (24–136 days) |
ND | OFC +ve in 8/10 |
Significant score reduction (from >12 to 6) |
ND | Useful for early diagnosis and to monitor response to therapy |
| Rigley (2017) [133] |
Prospective | 58 (<1 year) |
ND | OFC +ve in 2/2 | Score reduction in all (from 16.5 to 3.4, average values) | ND | Useful for early diagnosis, may help reduce specialist consultations |
| Bajerova (2017) [134] |
Cohort | 121 (6 weeks– 1 year) |
ND | OFC +ve in 11/18 |
Performed in 21 | ND | A cut-off of 8 reached much more frequently in allergic patients, but a lower threshold could increase sensitivity |
| Prasad (2018) [135] |
Observational Cross-sectional | 83 (0–24 months) |
+ve sIgE and/or SPT = 26/83 (31%) | Diagnosis confirmed in 70: by OFC in 56% of cases | ND | CoMiSS>12 Sens = 77% Spec = 66% PPV = 93% NPV = 33% |
High PPV confirming the reliability of parameters included in CoMiSS |
| Armano (2017) [136] |
Prospective | 40 (3–41 months) |
ND | OFC +ve in 40/40 | 38/40 score reduction >50% | Score ≥ 12 (in 17/40, 42.5%) predicted diet efficacy with 100% PPV and 9% NPV | Selection of candidate patients for diet |
| Salvatore (2019) [137] |
Prospective | 47 (1–12 months) |
+ve SPT in 8/47 = 17% | OFC in 21/39 patients responsive to diet +ve in 6 (29%) |
In 19/47 (40%) score reduction ≥50% | Best cut-off = 9 for response to diet: Sens = 84% Spec = 85% PPV = 80% NPV = 88% |
To predict diet response in children with persistent GI symptoms. |
| Vandenplas (2013) [138] |
Prospective /Multicentric |
116 (80-64 days (median of two groups respectively) |
sIgE>0.35 KU/L = 7.5% +ve SPT = 17% (rash); 10.5% (papule) |
OFC in 85/116 (74%) +ve in 69% |
Significant score reduction after 1 month diet | ND | CoMiSS useful for CMA diagnosis (OFC positive in 70% with score ≥12) |
| Vandenplas (2014) [139] |
Prospective/ Multicentric |
40 (3.4 months) (mean age) |
SPT = 15/40 (37.5%) tested only 17 cases | OFC in 38/40 +ve in 38/40 |
Score significantly reduced after 1,3,6 months of diet | ND | ND |
| Vandenplas (2016) [140] |
Prospective/ Multicentric |
71 (6 months) |
ND | OFC in 50/71 (70.4%) +ve in 34 |
After 1 month of diet, score significantly reduced in both confirmed and unconfirmed CMA (OFC not performed or negative) | ND | ND |
| Vandenplas (2017) [141] |
Aggregate analysis of the previous 3 studies | See above | See above | See above | Both a score <5 (median) and a score reduction from 13 to 5 (median) after 1 month of diet increase likelihood of CMA (+ve OFC) | See above | See above |
| Kose (2018) [142] |
Cohort | 112 (5.6 months (mean) |
sIgE and SPT +ve = 66/112 (59%). | OFC in 46/112 (41%) | Significant score reduction after 1 month of diet in infants allergic to milk, egg or both. | Score reduction after diet ≥50%: Sens = 83.7% 84.6%, 87.5% for milk, egg allergy or both respectively |
Score reduction after diet ≥50% to be used for diagnosis of FA |
| Selbuz (2020) [143,144] |
Prospective | 168 (0–12 months) |
+ve sIgE = 23/168 (13.8); +ve SPT = 20/168 (12%). |
OFC in 154/168 (91.7%) +ve in 91/168 (54,2%) |
After 4 weeks of diet, score reduced by ≥3 points in 154 (91.7%) | Cut-off 12.5: Sens = 64.8% Spec = 54.4% |
Association of symptoms in CoMiSS helps in recognition of CM-allergic infants |
| Vandenplas (2020) [145,146] |
Cohort | 148 2.3 months (median) = Spanish cohort. 72 3 months (mean) = Belgian cohort. |
ND | Spanish cohort: OFC in 13, score ≥10 +ve in 10/13 (76%), score>12 +ve in 7/8 |
ND | ND | ND |
| Kherkhheulidze (2017) [147] |
Prospective | 34/<1 year | ND | ND | Significant score reduction after 2 weeks of diet. | ND | ND |
Abbreviations: CoMISS: Coe’s Milk Related Symptoms Score; ND = Not Done; +ve = positive; Sens = Sensitivity; Spec = Specificity; PPV = Positive Predictive Value; NPP = Negative Predictive Value; SPT = Skin Prick Test; OFC = Oral Food Challenge; CMA = Cow’s Milk Allergy; FA = Food Allergy; GI = gastrointestinal.