Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening

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.

Inclusion Criteria:

1. Women 18 years of age or older at enrollment

2. Has an established viable singleton pregnancy

3. Is recommended for routine GDM screening between 24-28 weeks gestation

4. Has confirmed gestational age of 24-28 weeks at the Screening Visit

5. Is willing and able to provide documentation of informed consent

Exclusion Criteria:

1. Has diabetes before pregnancy or has already been diagnosed with GDM

2. Has contraindications for drinking oral glucose solution up to 100 g of sugar

3. Is taking metformin for any reason

4. Has any concomitant illness, disease or condition that, in the clinical judgment of
the investigator, is likely to prevent the subject from complying with any aspect of
the protocol, or that may put the subject at unacceptable risk