Document Detail


The development and evaluation of Sevatest ELISA hCG Micro I. kit as a test for pregnancy.
MedLine Citation:
PMID:  3221094     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The enzyme-linked immunosorbent assay (ELISA) method of sandwich type for determination of human chorionic gonadotropin (hCG) in serum or urine using horseradish peroxidase as an enzyme label and microtiter ELISA plates (or polystyrene microtubes respectively) as a solid phase support for antibody was developed. Test sensitivity of 200 mIU hCG per milliliter is approximately sixfold greater than the available hemo- or latex agglutination tests; quantitative hCG ELISA method has sensitivity of 6 mIU hCG per milliliter. In order to evaluate the usefulness of the method for early pregnancy detection 5,000 urine samples were prospectively collected and results correlated with outcome of pregnancy. Reliability of the test performed on routine basis at the Institute for the Care of Mother and Child in Prague proved to be 97.2% for intrauterine pregnancy detection, in 2.52% the test result was "+ -", and only in 0.28% the results were erroneous. For samples sent with the diagnosis of suspected extrauterine pregnancy 93.5% of correct results, 4.35% of "+ -" and 2.17% of erroneous results was found.
The enzyme-linked immunosorbent assay (ELISA) method of sandwich type for determination of human chorionic gonadotropin (hCG) in serum or urine using horseradish peroxidase as an enzyme label and microtiter ELISA plates (or polystyrene microtubes respectively) as a solid phase support for antibody was developed. Test sensitivity of 200 mIU hCG/milliliter is approximately 6 times greater than the available hemo- or latex agglutination tests; quantitative hCG ELISA method has sensitivity of 6 mIU hCG/milliliter. In order to evaluate the usefulness of the method for early pregnancy detection, 5000 urine samples were prospectively collected and results correlated with outcome of pregnancy. Reliability of the test performed on a routine basis at the Institute for the Care of Mother and Child in Prague proved to be 97.2% for intrauterine pregnancy detection, in 2.52% of the test result was "+ -", and only in 0.28% were the test results in error. For samples sent with the diagnosis of suspected extrauterine pregnancy, 93.5% were correct results, 4.35% were "+ -", and 2.17% were results in error.
Authors:
P Podrouzek; Z Krabec; P Mancal; J Presl
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of hygiene, epidemiology, microbiology, and immunology     Volume:  32     ISSN:  0022-1732     ISO Abbreviation:  J Hyg Epidemiol Microbiol Immunol     Publication Date:  1988  
Date Detail:
Created Date:  1989-03-17     Completed Date:  1989-03-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  2985116R     Medline TA:  J Hyg Epidemiol Microbiol Immunol     Country:  CZECHOSLOVAKIA    
Other Details:
Languages:  eng     Pagination:  467-76     Citation Subset:  IM; J    
Affiliation:
Research Institute for the Care of Mother and Child, Prague, Czechoslovakia.
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MeSH Terms
Descriptor/Qualifier:
Chorionic Gonadotropin / analysis*,  blood,  urine
Enzyme-Linked Immunosorbent Assay / methods
Evaluation Studies as Topic
Female
Horseradish Peroxidase / diagnostic use
Humans
Pregnancy
Pregnancy Tests, Immunologic / methods*
Pregnancy Trimester, First
Pregnancy, Ectopic / blood,  urine
Chemical
Reg. No./Substance:
0/Chorionic Gonadotropin; EC 1.11.1.-/Horseradish Peroxidase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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