Реагенты, реактивы для диагностики инфекционных заболеваний: наборы реагентов для in vitro диагностики вирусных гепатитов:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Bio-Rad, ФРАНЦИЯ

класс:

изделия медицинского назначения

Производитель:

Bio-Rad

Дата Авторизация:

2023-01-03

Характеристики продукта

Genscreen
™
ULTRA HIV Ag-Ab
1 plate -
96
72386
5 plates -
480
72388
SCREENING KIT FOR THE DETECTION OF HIV P24 ANTIGEN
AND ANTIBODIES TO HIV-1 AND HIV-2 IN HUMAN SERUM/PLASMA
BY ENZYME IMMUNOASSAY
883637 - 2013/10
4 [EN]
CONTENTS
1.
INTENDED USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 5
2.
SUMMARY AND EXPLANATION OF THE TEST . . . . . . . . . . . . . . . . .
. . . . . . . . . 5
3.
PRINCIPLES OF THE PROCEDURE . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 5
4.
REAGENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . 6
5.
WARNING AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . 7
6.
SPECIMENS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . 9
7.
PROCEDURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 9
8.
TEST LIMITATION. . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . 12
9.
PERFORMANCES CHARACTERISTICS. . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . 13
10.
BIBLIOGRAPHY REFERENCES.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 16
[EN] 5
1. INTENDED USE
The Genscreen™ ULTRA HIV Ag-Ab is a qualitative enzyme immunoassay
kit for the detection of HIV
p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in
human serum or plasma. This kit
can be used for both HIV Ag and HIV Ab screening of blood donations
and for diagnostic use.
2. SUMMARY AND EXPLANATION OF THE TEST
The
acquired
immunodeficiency
syndrome
(AIDS)
is
a
virus
inducing
infectious
disease
characterised by strongly depressed immunity.
Two types of viruses related to the Lentivirus group have been
isolated from lymphocytes of patients
suffering from AIDS or its prodromes. The first one, named HIV-1, was
isolated in France then in the
United States. The se