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Clinical Chemistry 52: 1794-1801, 2006. First published June 29, 2006; 10.1373/clinchem.2006.070607
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Right arrow Point-of-Care Testing
(Clinical Chemistry. 2006;52:1794-1801.)
© 2006 American Association for Clinical Chemistry, Inc.

Point-of-Care Testing

Immunofluorometric Point-of-Care Assays for the Detection of Acute Coronary Syndrome-Related Noncomplexed Pregnancy-Associated Plasma Protein A

Saara Wittfooth1,a, Qiu-Ping Qin1, Juha Lund2, Ilkka Tierala3, Kari Pulkki4, Harri Takalo5 and Kim Pettersson1

1 Departments of Biotechnology and 2 Medicine, University of Turku, Turku, Finland.
3 Departments of Medicine and 4 Clinical Chemistry, University of Helsinki, Helsinki, Finland.
5 Innotrac Diagnostics Oy, Turku, Finland.

aAddress correspondence to this author at: Department of Biotechnology, University of Turku, Tykistökatu 6 A, 6th floor, FI-20520 Turku, Finland. Fax 358-2-333-8050. E-mail saara.wittfooth{at}utu.fi.

Background: We recently reported that the pregnancy-associated plasma protein A (PAPP-A) form specifically related to acute coronary syndromes (ACS) is not complexed with the proform of eosinophil major basic protein (proMBP). The aim of this study was to develop rapid point-of-care immunoassays for the measurement of the noncomplexed PAPP-A.

Methods: We developed immunofluorometric noncompetitive dry-reagent assays for total PAPP-A with 2 PAPP-A subunit-specific monoclonal antibodies and for PAPP-A/proMBP complex with 1 PAPP-A subunit-specific antibody and 1 proMBP subunit-specific antibody. The concentration of noncomplexed PAPP-A was determined as the difference of the results obtained with the 2 assays.

Results: The assays were linear from 0.5 to 300 mIU/L. The analytical detection limit and functional detection limit (CV <20%) were 0.18 mIU/L and 0.27 mIU/L for total PAPP-A assay and 0.23 mIU/L and 0.70 mIU/L for PAPP-A/proMBP assay, respectively. The total assay imprecisions were <10%, and recoveries were 88%–107% for both assays. The mean difference (95% limits of agreement) between the new total PAPP-A assay and a previously reported total PAPP-A assay was –3.2% (–45.7% to 39.3%; n = 546; P = 0.0019). In serum samples from 159 non-ACS individuals, median concentrations (interquartile range) were 2.42 (1.14) mIU/L for total PAPP-A, 2.20 (1.18) mIU/L for PAPP-A/proMBP, and 0.18 (0.63) mIU/L for noncomplexed PAPP-A. Total PAPP-A and PAPP-A/proMBP, but not noncomplexed PAPP-A, correlated with age (r = 0.290, P = 0.0002; r = 0.230, P = 0.0035; r = 0.075, P = 0.3483, respectively).

Conclusions: The new assays described revealed that noncomplexed PAPP-A is found only in negligible amounts in non-ACS samples.






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Copyright © 2006 by the American Association for Clinical Chemistry.