Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
Brief description: Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)
Detailed description: Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value (NPV) and positive predictive value (PPV) to identify pregnant women at risk for GDM. Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated.
Detailed description: Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value (NPV) and positive predictive value (PPV) to identify pregnant women at risk for GDM. Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated.