DEVHISE Study (IZSVe Testing Platform)
Study profileDescription
The DEVHISE Study (IZSVe Testing Platform) aims to develop a high-throughput serological testing platform for mass screening of paediatric and adult cohorts. Blood samples and personal data are collected from paediatric patients at the University Hospital of Padua, Italy, and adult employees of IZSVe.
Countries involved: Italy
Sample size: 73 adults and 92 children
Metadata collected
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| Data collected? | |
| Demographics | |
| Date of birth | |
| Age at contact | ✅ |
| Sex | ✅ |
| Gender | |
| Ethnic group | |
| Locality (of registration/ health care setting) | ✅ |
| Locality of residence | |
| Health status and exposures | |
| Height | |
| Weight | |
| Date of anthropometrics | |
| HIV status, timing of HIV diagnosis | |
| HIV treatment | |
| HIV pre-exposure prophylaxis | |
| HIV-related lab tests (HIV RNA, CD4) | |
| Other co-morbid conditions / co-infections | ✅ |
| Medications for other chronic conditions | |
| Current smoker | |
| Risk factors for mpox acquisition | |
| Mpox/other infections presentation, symptoms, medications, hospitalisation | |
| Date of symptom onset | |
| Signs and symptoms | |
| Lesion assessment | |
| Lesion resolution | |
| Outpatient facility presentation dates | |
| Hospitalisation dates | |
| ICU admission | |
| Procedures and dates | |
| Complications | |
| Medications (type, dates / duration) | |
| Medical management | |
| Imaging findings* | |
| Severe disease indicators | |
| *exposed infants and pregnancy ultrasounds | |
| Mpox/ other infections outcomes, death | |
| Outcome at discharge from care | |
| Sequelae | |
| Date of / age at death | |
| Cause of death | |
| Place of death (i.e., setting) | |
| Vaccines | |
| Mpox / orthopoxvirus vaccine doses and dates | |
| Vaccine administration route | |
| Vaccine history | ✅ |
| Pregnancy & birth | |
| Pregnancy dates, length of gestation | |
| Number of fetuses | |
| Maternal age at delivery | |
| Pregnancy complications | |
| Pregnancy outcome | |
| Medications in pregnancy | |
| Vaccines in pregnancy | |
| Parity / gravidity | |
| Smoking | |
| Mpox testing in pregnancy | |
| Mode of delivery | |
| Sex of baby | |
| Infant anthropometrics at birth | |
| Congenital anomalies | |
| Mpox/ other infections diagnostics | |
| Sample type | |
| Sample date | |
| Type of PCR test | |
| PCR test date | |
| PCR result pos / neg | |
| PCR Ct value | |
| Type of serology test | |
| Serology test date | |
| Serology result | |
| Other lab tests | |
| Mpox/ other infections sample collection / storage | |
| Sample type collected | ✅ |
| Sample collection date | ✅ |
| Sample collection time | ✅ |
| Sample processing | ✅ |
| Sample quality | ✅ |
| Consent to use research sample | |
| Consent to share research sample |