SPDData {NPP}

Dataset for Diagnostic Test (PartoSure Test, Medical Device) Evaluation for Spontaneous Preterm Delivery

Description

The diagnostic test was developed to aid in rapidly assess the risk of spontaneouspreterm delivery within 7 days from the time of diagnosis in pre-pregnant women with signs and symptoms. The same diagnostic test was used for two populations in US and EU respectively. The number of counts in the four cells (True positive, false positive, false negative, true negative) was recorded.

Usage

data("SPDData")

Format

A data frame with 2 observations on the following 5 variables.

Data.Region

region where the diagnostic test was conducted

TPDP

number of subjects with tested positive and the disease status positive (true positive)

TPDN

number of subjects with tested positive but the disease status negative (false positive)

TNDP

number of subjects with tested negative and the disease status positive (false negative)

TNDN

number of subjects with tested negative and the disease status negative (true negative)

Source

https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160052C.pdf

Examples

data(SPDData)