Variation among immunoreactive trypsinogen concentrations michigan newborn screening 10 2007 4 2008
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Variation Among Immunoreactive Trypsinogen Concentrations, Michigan Newborn Screening, 10/2007-4/2008. Steven J. Korzeniewski, MA, MSc, Maternal & Child Health Epidemiology Section Manager Grigorescu, V., Young, W., Hawkins, H., Cavanaugh, K., Nasr, S.Z., Langbo, C. Outline. Background

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Steven J. Korzeniewski, MA, MSc, Maternal & Child Health Epidemiology Section Manager

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Variation among immunoreactive trypsinogen concentrations michigan newborn screening 10 2007 4 2008

Variation Among Immunoreactive Trypsinogen Concentrations, Michigan Newborn Screening, 10/2007-4/2008

Steven J. Korzeniewski, MA, MSc,

Maternal & Child Health Epidemiology Section Manager

Grigorescu, V., Young, W., Hawkins, H., Cavanaugh, K., Nasr, S.Z., Langbo, C.


Outline

Outline

Background

Research question

Methods

Results

Discussion

Public Health Implications


Background

Background

CF Screening in MI commenced Oct. 2007

IRT is used to identify infants at increased risk of CF for DNA testing.

Mutation analysis, using a panel of 40 CF mutations among > 96th percentile.

In the absence of a mutation sweat testing is recommended only among infants having IRT concentrations > 99.8th percentile.


Research question

Research Question

Anecdotal evidence suggested a high rate of false positives among NICU infants

This study explores variations in IRT concentrations in hopes of developing a strategy to reduce false positives.

R1: Do IRT concentrations vary among the general population by sex, race, birth weight, gestational age, and fetal growth ratio?


Methods

Methods

Data: Newborn screening IRT concentrations and infant demographic data collected from Oct 2007-April 2008 were used for this study.

Analysis: Crude and adjusted generalized linear models (GLM) of the association between demographic variables and IRT concentrations

Least squares means and p-values are reported

LS-means are within-group adjusted means, they estimate the marginal means for a balanced population (as opposed to the unbalanced design). Also called estimated population marginal means by Searle, Speed, and Milliken (1980).

We also calculated means and percentiles (96th, 99.8th) by race and gestational age strata


Results

Results


Results1

Results


Updated results

Updated Results

At one year (Oct 2007-Oct 2008)

Effect modification of race by gestational age absolved

Racial variation remained significant in both crude & adjusted models


Conclusion

Conclusion

Failure to account for racial variation results in:

Over sampling of black infants

those at lower risk of CF

Under sampling of white infants

those at the greater risk of CF

False positive and false negative rates could be inflated

However, no false negatives have been detected thus far


Public health implications

Public Health Implications

Calculation of IRT % cutoffs stratified by race would:

Reduce the FPR & Improve PPV

Require further research to discern appropriate cutoffs, particularly for racial minorities or those with missing data

Require significant change in laboratory operating procedures

Sorting of cards

Verification of Race information

Development of strategy to calculate cutoffs over time


Acknowledgements

Acknowledgements

Co-Investigators: Grigorescu, V., Young, W., Hawkins, H., Cavanaugh, K., Nasr, S.Z., Langbo, C.

NBS Follow-up Staff

CF Advisory Committee


Contact

Contact

[email protected]

Thank You


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