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Limitations in Qualitative Point of Care hCG Tests for Detecting Early Pregnancy.
MedLine Citation:
PMID:  23159297     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: Detection of early pregnancy in the healthcare setting is important for proper patient management. Qualitative point-of-care (POC) human chorionic gondaodtropin (hCG) testing is often used. There is a gap in the literature for evaluating patient samples with low (<300IU/l) hCG concentration using POC devices. METHODS: Specimens (urine, n=289; serum, n=269) with hCG concentrations between 2 - >5,000IU/l were evaluated by hCG POC testing. Approximately half of these had an hCG concentration <300IU/l. All specimens were evaluated using the OSOM and QuickVue+POC hCG devices. Pregnancy status was evaluated by patient chart review. RESULTS: The OSOM and QuickVue+devices were able to detect hCG in 53 % (OSOM) and 78% (QuickVue+) of urine samples with an hCG concentration range between 20 and 300IU/l. Serum samples with an hCG concentration range between 10 and 300IU/l gave positive results in 79 and 91% of samples tested using the OSOM and QuickVue+, respectively. False negative results could not be attributed to the high-dose hook effect, the hCG variant effect, or the interpreters' evaluation. The mean gestational age for specimens corresponding to the false negative results was 4weeks. CONCLUSIONS: The sensitivity of 2 commonly used hCG POC devices is insufficient for detecting very early pregnancy.
Authors:
Dina N Greene; Robert L Schmidt; Sandy M Kamer; David G Grenache; Carolyn Hoke; Thomas S Lorey
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-15
Journal Detail:
Title:  Clinica chimica acta; international journal of clinical chemistry     Volume:  -     ISSN:  1873-3492     ISO Abbreviation:  Clin. Chim. Acta     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1302422     Medline TA:  Clin Chim Acta     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012. Published by Elsevier B.V.
Affiliation:
Kaiser Permanente, TPMG Northern California Regional Laboratory, Berkeley, CA. Electronic address: dina.n.greene@kp.org.
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