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New kit for CAH testing
A new kit for CAH testing will be used by the Newborn Screening Program at the Arizona State Lab beginning on 9/28/09. 

Cutoffs and birth weight ranges have been adjusted for the new kit.  This is not a change in method for quantifying 17-OHP but is a change in the antibodies used in the PerkinElmer® AutoDelphia® Neonatal 17α-OH-progesterone kit (time-resolved fluoroimmunoassay).  

The new kit is more specific for 17-OHP and values obtained minimize contributions from other hormones which may be elevated because of stress.  Overall, the average results obtained are lower than the previous kit results.

Because of this downward change in values, the cutoffs have been adjusted.  However, even though the cutoffs have been lowered, we anticipate a marked reduction in the number of false positives reported.  When an abnormal result is reported there will be a much greater likelihood of a true positive, particularly in full-term, well babies. 

Early collection (<24 hours of age) and prematurity (low birth weight) will still produce false positives although using cutoffs adjusted for birth weight will help to minimize them.  The birth weight ranges have been changed to put low birth weight babies in separate categories from babies of normal birth weight (>2500 g).

We will continue to monitor our results with this test and will adjust cutoffs as needed to minimize false positives while identifying those at risk for classic CAH.

Please note that 17-OHP is elevated in the two most common forms of CAH (21-hydroxylase deficiency and 11ß-hydroxylase deficiency) but not in the other types.  Its determination is thus useful as a screening method for these two most frequently seen types of CAH or about 95% of all cases.  As with other screening tests, a negative result does not completely rule out the possibility of disease.

We will continue to communicate with you as we make changes to our testing and follow-up protocols for any of the disorders screened by our program.  If you have any questions related to this laboratory change, please do not hesitate to contact either Dr. Sundin Applegate, NBS Medical Director, at applegs@azdhs.gov or (602) 542-1223; or Ward Jacox, NBS Office Chief at jacoxw@azdhs.gov or (602) 364-1410.

If you have clinical questions, please contact one of the pediatric endocrinologists listed below:

Dr. Donnie Wilson

Phoenix Children’s Hospital, Endocrinology

602-546-0935

Dr. Khalid Hasan

Phoenix Children’s Hospital, Endocrinology

602-546-0935

Dr.  Roger Johnsonbaugh

Arizona Pediatric Endocrinology

602-274-5078

Dr. Alvin Perelman

Southwest Pediatric Endocrinology

480-323-4800

Dr. Ed Holland

East Valley Pediatric Endocrinology

480-464-8600

Dr. Mark Wheeler

University Physicians

520-626-6077

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