[Certification of a kit for immunologic tests].
A diagnostic kit for the determination of IgG antibodies to diphtheria toxin ("Abion", Germany) the use of analytical columns "Abicap" was studied in the specialized laboratory of the Tarasevich State Control Institute with a view to determine the possibility of its official registration in the Russian Federation. The kit was evaluated by the following criteria: the correspondence of the specified properties of the preparation to those actually observed; meeting the norms stated in the documents supplied with the kit and WHO requirements; the presence of advantages in comparison with the enzyme immunoassay. In the course of the trial positive results were obtained on all these points.
Bektimirov
T A
TA
State Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.
Petrov
V F
VF
Miete
P
P
Shobukhova
T S
TS
Nikolaeva
A M
AM
Tumanova
G M
GM
Erkhardt
U
U
Erkhardt
K
K
D004167:Diphtheria Toxin / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000592:standards*; D007074:Immunoglobulin G / Q000032:analysis*; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D015203:Reproducibility of Results; D012426:Russia; D012698:Serologic Tests / Q000592:standards*; D013223:Statistics as Topic; D014944:World Health Organization
D004167:Diphtheria Toxin; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic
O sertifikatsii nabora dlia immunologicheskikh ispytaniĭ.