An Evaluation of Thirteen Pregnancy Test Kits for Professional Use
Auteur : Deka Salaad, Agnes D'Souza, M. J. Wheeler
Date de publication : 1998
Éditeur : Medical Devices Agency
Nombre de pages : 76
Résumé du livre
Thirteen pregnancy test kits which use a flat slide device have been evaluated. These tests would normally be used in a hospital laboratory, but might also be used in a GP surgery. All the kits were very sensitive and could detect hCG in urine at 50 IU/L or less. Six of the kits were also able to detect hCG in serum but this feature was not tested. A random selection of one hundred and ninety-nine urine specimens, sent to the Immunology Department at St Thomas' Hospital for pregnancy testing were collected. The hCG concentration in the urine was determined using the Serono MAIAclone kit. Urine specimens from normal men, non-pregnant women and menopausal women were also tested as well as urines containing blood or a high protein concentration. Each product has been evaluated as a separate entity but a comparison of the kits is also presented. Suggestions for the determination of hCG in urine for pregnancy screening are also given.