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011-gepatit2_123-129
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Новое поколение ИФА тест-систем
для лабораторного скрининга гепатита С
Тест для совместного определения антител и антигенов вируса ?
?МОНОЛИЗА ВГС АГ-АТ УЛЬТРА?
Колупаев В.Е., Яшина Т.В.
ООО ?Био-Рад Лаборатории?, Москва
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?????????, ??? ????? ?????, ?????????????? ??????? ???????? ? (???) ? ????, ?????????
500 ????????? ???????. ? ?????? ?? ??????????
???·???????? ? 5 ????????? [1]. ? ??? ???????
? ???????? ???????? 20% ?????? ? 70% ???????
??????????? ????????? [2]. ???·???????? ???????? ???????? ??????? ??????? ?????????? ????????????? ???????? (60?80%) ??? ???? ?????? 20%
????????? ????????????? ?????????? ????????????. ?? ????????? ?????????? ???????, ???????
????? ??????? 10?20 ???, ??????????? ????????,
??? ???????, ???????? ???????????? ???????, ??????????????? (10?20%) ? ?????? ???? ?????? ????????? ??·???????? ?????? [3]. ? ?????????????? ????????????? ?? ????????? ??????????? ??????????? ???????? ???????? ·??? ????????, ???
?????? ?????????? ??????????????? ??????? ????????????? ??????? ???????? ? ??????????? ?????? ? ???????? ?????????? [4?6]. ????? ?·?????,
????? ??????? ???????? ? ??????? ? ??? ????? ? ??
?????? ??????????? ????????.
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???????????????? ????????, ???????? ?·??????????, ???????? ? ??. ??????????????? ???????? ?
????? ?????·?????? ???????????? ??????????
????????? ?? ?????? ??? 60?90%. ??????????, ?
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??????? ??·????????, ?????????? ????? ??????????? ???????, ??????????? ??????? ?????????????????? ?????????? ????????? ??????? ????????????, ??? ?? ??????, ? ??? ????? ? ? ????????
??????? ???????????? ???????? ? ?????????? ??
·???? 20% ?? ???????? ??????? ????????????? ???????? [7?9]. ?????? ?????? ?????, ??? ???·???? ??????????? ?????????????? ????????, ????????, ???????????? ?????????????? ???????
??? ?????? ?????????? ???????? ???????? ?, ????????, ????? ??????? ? ??????????? ???????????? ???????? ? ???????? ???????????? ????????????? [7]. ????? ?·?????, ????? ?? ????????
???·?????? ? ???????, ??????????? ? ?????????
??????????? ???????? ?, ???????? ???????????????? ????-?????? ?? ?????? ??????? ??·????????.
???·?? ???????? ? ???????????????? ????-??????
????????? ??? ????????? ????????? ?????, ???
??? ??????????? ?????????????? ????? ????????
????? ?? ????? ???????? ????????.
????????????? ???????? ??????????????? ? ???????? ?????? ?????????? ?·?????????? ? ????????? ??????????? ??????? ? ??? (??) ? ?????????????? ????????????????? ??????? (???) [10]. ???????? ??????? ??·????????? ???????? ???????? ? ???????? ? ??????????? ?????????????????? ????????
??? ? 1988 ???? [11].
?? ???? ?????????? ????????????? ? ?????????
??? ?????? ????????? ???????? ??????????? ???
·???? ???????????????.
???????????? ???????? ?7/2005
123
011-gepatit2_123-129
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Page 124
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????????????? ???, ???????? ?? ?????????? ?????????????? ?? ????-?????? ???????? ???????. ???
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???????? ?. ? ???????? ??????? ????-??? ?? ?????????? ? ????? ?????? ???? ????????????? ????????, ?.?. ????? 4?9 ???. ? ·???? ????? ?????????
(???. 1) [14], ??? ?????????? ???????????? ??????????????? ??????? ?? ?????? ? ?????? ???????? ?.
??????????? ??? ??? ??????? ???
? ????????? ????? ·?????? ???????? ?????????
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???????? ????? ?????? ???????? ????????, ???????????? ? ????????? ???????? ?? 7?21-? ????
????? ????????????? ??? [15]. ? ??·?????????
???????? ??? ?·????????? ??? ??? ????? ??????????? ???, ??? ???? ?? ???·???? ??????????????
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?????? ?? ?????? ??????? ? ?????? ????????? ?????? ??·???????? ??? ??? ??????????? ????????
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????) ??????????? ????????????, ???, ?????????
124
???????????? ???????? ?7/2005
????????? ???????? ???????? ?????? ?????? ??????? ??? ??? [16] (???. 1). ??? ?? ????? ?????????????? ? ???????? ????????????? ?????? ?
???????? ???????????? ?????????????. ????????
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??? ? ???????? ?·??????????? ?????? ? ????·?
????? ????????? ?????, ?????? ? ???????·???????? ????????????? ??? ? ????????? ??????? ???????? ???????? [17, 18, 19].
??????????? ????????? ??????
?????? ???????????? ????-??????? ??? ??? ????????? ???????? (Core) ???????? (??) ????????? ??
????? ??????·???????????? ?????????? ? 1999 ????.
? ???? ??????????? ????????? ???? ???? ????????????????? ??????? ???????????????? [20?22]. ??????, ?????????? ???????? ???????????? ?? ??? ?
????? ? ????????? ?????? ????????, ???·?????????
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? 2004 ???? ???????? ????-??? ??·?????????
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????????? ??? ??-?? ??????? ????????
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????? ? ??? ?? ????? ?????????????. (???. 2)
? ?????? ??????????? ?????????????? ???????? ? ?????????? ·???? ?????? ???????? ?; ?????·???????? ·???? ? ???????? NS3, NS4, ? ????? ???????????????? ??????? ?????? (Core)
???. ??·?? ?????????? ??????????? ·?? ??????
?? ?????? ·??????? ?????????? ??????? ????????????, ? ????? ????????????? ????????? ?????????? ????????? ????-?????? ???????? ???????. ???????? NS4 ?????????? ??????? ????????
????????????? ? ?????????????? ?????????. ????-NS3 ? ????-Core ?????????? ? ·???? ??????
?????, ??? ????????? ????????. ? ·?????????? ??-
011-gepatit2_123-129
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? ???????????? ???.
NS5 ? ???????? ?????????? ???????????? ??
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?? ? ???-?????????? ?????? ???????, ??? ????????? ??????? ?? ????????????? ?????, ???????? ? ????? ??????? ?? NS5. ? ?????? ???????,
?? ???? ?????? ???????????? ?? ·??? ????????????? ???????, ????? ????-NS5 ?? ??????? ???????????? ???????? ?????????????. ?????????????? ???????????? ?????????? ???????? ??????????????? ????????????? ??????????? ????NS5 ?? [23, 24, 25].
? ???????? ????????? ??? ??????????? ?? ??????, ???????????? ??????? ·???????????????? ?????????????? ????????, ??????????? ??
??????????????. ??????????? ????????? Core
?? ? ??????? ????-??????? ????????? ?????????
??? ?????????????? ? ???????? ??????????????? ????-Core ??, ??????? ?????? ? ??????
????-??????? ? ???????? ????????? ??? ??????????? ??. ??? ???? ??????? ???????????? ?? ????????? ? ?? ???????????? ?·????? ???????????. ???????? ??? ??????????? ????-??? ?? ?
???????? ???????????? ??????? ???????? ? ????????????? IgG.
??? ???????? ????-??????? ?·???????? ???????? ?? ???·???? ?? ????????????? ?????????????:
?·????? ??? ???????????? ?? ???·??? ??????????????? ??????????, ???????????? ???????? ?·?????? ? ????????? ??????????? ? ??????? ????????
?????????. ????????????????? ??????? ?? ????????? ??????????? ? 2 ???? 30 ?????.
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?·?????? ? ???????????? ????????????????? ???????. ? ????????????????? ????????? ???????????
??·???????? ????????????????? ????? Bio-Rad
Laboratories (????-??-??????, ???????) ??????
????? ? ???? ? ?????, ???????????????? ??·???????? ??? ??????????? ??????? ? ?????? ? ??????
(???????). ????? ??????????? ???????????? ??????????? ???????????? ? ???????????? ??????????? ?????? ?? ????????? ? ? ? (???????), ? ????????? ??????? ?? ???????????, ? ???????????????? ????????? ????????? ???? (?????, ???????)
? ????? ? ???????????????????????????? ?????????
·??????? ?. ????? (??????). ?????????? ???????????? ? ?????????? XV ????????? ??????????????
?·?????? ??????????????? [27] ? 8-?? ??????????
????????? ???????????? ?·?????? ???????????
??????????? [30].
?????? ???????????
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????????????????? ??????????????? ??????? ? ?????? ?????? ????????
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??????? (BCP-IMPATH,
BBI, NABI) ? ??????????? ?·?????? ????????? ?
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? ??????? ????-??????? ????????? ???
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35 ???????????? ???????. 2. ???????? ????-??????? ???????? ??? ??-?? ??????
????????????? ???????.
???????????? ???????? ?7/2005
125
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?·????? ???????? ? ??·? 1a, 1b, 2b, 3a ??·????
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?? ???. 3 ??????????? ?????????????? ???????
????? ?? ???????? ??????? (BCP 6211). ?????????????? ?????????? ???????????? ??, ?? ?
???·???????????? ??-?? ????? ??? ????????????
????????? ?·?????? ??????, ??????? ·??? ?????
? ?????? ????????????? ? ?????? ? ???? ?? ????????, ??????????????? ????????? ?. ?? ?????????????? ??? ???????? ????? ?????? ????? (?????,
??????? ?? ??????? ?????? ?????). ????????????
??? ???????? ?????????? ???????????? (?????????
?????????? ????????? ?·????? ? ??????????? ?????????? ????????? ? ?????? ??????????) ???
???? ??????????? ????-??????. ?? ??????? ?????,
??? ???????????? ???·???????????? ????? ? ?????? 20 ????? ????????? ? ???????????? ?? ?????.
??? ?? ????-??????? ?????????? ???????? ???·?????????? 60 ????? ? ????????? ?????????????? ??????????. ????????? ????????, ??? ???????????? ???·???????????? ????? ??????????? ??????? ??? ???? ??????????? ?·??????, ????? ??? ?????????? ?? ????? ?? 80 ????? ???????? ?? ????.
??? ????? ????????????????? ?· ?????????? ????????? ???????? ? ????????? ???????? ?? ???????
?????? ?????????????. ????? ?·?????, ??? ?????? ????????????????? ?????? ???·????????-
???. 3. ????????????????? ?????? BBI PHV ? 917
126
???????????? ???????? ?7/2005
??? ???? ????????? ??? ??-?? ???????
?????·?? ???????? ??? ???????? ????????????
? ?????????? ??????, ????? ??? ????-??? ???????? ???????????? ?? 60 ???? ????? [26].
????????? ? ???????????? ???????????? ????-??? ?? ????-?????? ?? ???? 35 ????????????????? ??????? ????????, ??? ????????? ? ???·??????????? ??-?? ????? ??????????? ??? ????????????? ? ??????? ?? 17 ???? ??????, ??? ?
??????, ?????????? ?????? ?? ? ?????? (???. 4).
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????????????? ?????? ??????? ???????? ???????????? ??????????? ??????? ?·????? ???????
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????? ????????? ??? ??-?? ??????? ?????
?? 4,4 ???.
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??? 85 ?·?????? ?????? ????????? ??? ??-??
??????? ?????????? ??? ?????????????.
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??????? ????????? 107 ?????????
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011-gepatit2_123-129
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????????? ????-?????? ?? ????????? ? ??? ?????????????
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??? ????-??????? ????????? ??? ??-?? ??????? ?????????? ??????? ???????? ? ??????? ??
26,8 ????? ??????, ??? ?????? ???????????? ??????? ?? ?????. 70,5 % ?·??????, ??·?????? ?? ?????????, ? ??? ?·????? ????? ????????????? ? ????
???????????? ???????????? ??-?? ?????? ??? ?????????????. ????????????? ? ???????????? ???
??????? ??? ?? ????? ????????? ????????, ???
??????? ????????????????? ??????????????? ??????? ???·???????????? ????? ?????????? ????? 5,1
????? ???????????? ??? ???????????? ?????????
(??????????????) ????????? [28].
????? ?·?????, ????????????? ????-???????
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????????????? (????? ?? 70%) ?????????? ??????????????? ???? ?? ????????? ? ????????????
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???·???????????? ??-?? ????? ??????????? ????????? ? ?????????? ???, ??????? ??????? ???????? ?, ? ?????????.
? ??????????? ?????????????? ????????????????? ????????? ???????????????? ????-??????? ????????? ??? ??-?? ??????? ??????????? ?? 646 ????????????? ?·?????? ????????? ? ?????????????? ????????? ???????? ?,
?? ??????? 405 ?·?????? ·??? ??????????????
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(1?6). ??? ????????????? ?·????? ·??? ?????????? ??? ?????????????. ??? ?·?????????? 200
?????????, ?????????????? ?????????? ??·?????? ?????? ???????? ? ? ???????????????? ??-
·???????? ·??????? ?. ?????? (???????), ???????????????? ?????????
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??? ?????????????. ?????????? ?????????? ????????? ????????? ? ????????????, ??????????? ??????? ??????? ??? ??????????? ????-??? ?? [26].
???????? ??????????? ?????? ??? ???????????? ?????? ? ??????????? ???? ????????, ????????? ? ??????? ?????????? ??????, ????? ????-??????? ????????? ??? ??-?? ??????? ?????????????????? ??????? (100%) ????????????????.
? ????????? ??????? ?? ??????????? ·??? ??????????? 2169 ?????????, ??·?????? ? ??????? ?.
????????????. ??????????? ???????????? ???????????? ? ??????? ????-?????? ????????? ???
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·? ? ????? ?? ???? ??? ??????, ????????????? ????????, ????????? ????????????? ? ??????·???? ? ?
??????? ?????? ???. ?? 2169 ?·?????? ? ??????? ????-??????? ???????? ??? ??-?? ?????? 32 ????????? ·??? ?????????? ??? ?????????????, ??? ·??? ???????????? ? ??????·????.
??????, ?????? ? 17 ??????? ?? ????????? 32 ?·?????? ????? ??? ???????????? ?????????? ??????? (> 200 ??/?? ??? ???) [29].
??? ?????????? ??????????????? ???????????? ???????????? ????? ????? ? ????????? ???? ?
?????? ??????? ??????? ????? ???-?????????????? ???????????????? 20 ??????? ? ?????? ????????? ?. ??? ·?? ??????????? 1, 3 ? 4 ??·??????. ??? ???? ??? ???? ????????? ??????????? ?????????, ?????????? ?? ????????????? (???
??? (-)/??(-)). ??? ??????????? ?????????????
????? ????????? ?????????????? ?????????? ?
???????????? ???????? ?7/2005
127
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Page 128
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??? ? 9 ????????? ?????? ????????????? ????????? ??????????? ? ????? ? ??? ?? ?·?????. ???
???? ????????? ????????????? ????????? ·?? ???????????? ??? ????????? ?????? ????? ?? ??????? ??????????? ???????. ? ????????? 7 ?????????, ???????, ??? ???????, ·??? ???????????? ??? ???? 4, ????????? ???·???????????? ????? ????????? ?????????????? ??? ?????????? ???????????????? ?·??????. ??????? ????????, ???
??????? ?? ? ????????? ???????????? ?? ?????????? ??????????? (?? 5 ???????) ??????? [30].
??????????????? ???????? ?? ?????? ???????? ??????????? ??? ???-??????????????.
????? ???·??????????? ??-?? ???? ????????????????? ??????? ??????????? ????????????? ??? ??? ?·?????????? ???????????
????????? ? ???????????? ?????? ???????????????? ???????? ? (?. ????????????, ??????????), ??? ? ? ????????? ????? ????? ??? ??????? ????????????? ??? ???????? (?????????
????, ?????).
????? ?·?????, ????????? ??? ??-??
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???????????? ?·??????????, ? ??? ????? ? ????????? ????? ?? ??????? ?.
????????????? ????? ??????????? ?? ??????????? ???????????? 12401 ?·?????? ?????, ?????? ? ????????? ??·???? ???????, ? 4 ?????????
??????? ????? ???????????? ?????. ?? 12 399
????????? ? ????????? ?·?????????? ·??? ??128
???????????? ???????? ?7/2005
?????? 23 ????????????? ?·?????. ??? ????????? ??????? ????????????? ?·?????? ? ??·???
19 ????????? ????? ????????? ???????????.
????? ????????? ??? 2-? ?·?????? ????????????? ????????? ????????????. ????? ?·?????, ??????????? ????-??????? ??? ????????? ???????
??????? ??? ????????????? 0,15 % ?? ?·????
?·???? ?·?????? (19/12 399). ?????????????, ????????????? ????????? ??? ??-?? ???????
?????????? 99,85%.
???????????? ????????????????? ???????????
? ???????????? ?? ??? ?? ? ??????????? ??????????? ? 68 ??????????? ?????????????. ??????????? ???????? ???????? ???????? ????? 10 %.
??????????
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???????????? ? ????????? ??????? ??? ?????, ?????????????? ??????????? ??? ??? ? ???????????? ?·?????? ??????? ??? [27].
??????? ???????????????? ??? ??????????? ????-??? ??????? ? ????????? ? ???????????? ???????? ????????? ???????????? ????? ????-???????
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???????????????? ? ????????????? ????? ???????? ?????? ?????? ????????? ????-?????? ? ???????????? ???????? ?. ????????? ????? ????? ?
????·? ????? ???????? ·?? ?????????????? ?????????? ? ???????? ?????? ??????????? ????????? ???????????????? ???????????? ????????????, ???????? ??????? ????????????????? ??????????????? ??????? ??????????? ?? ?????? ????????? ???????? ??????? ???. ? ???????????
???????? ·???? ?????? ????????? ???????? ???????? ? ??????? ????-??????? ?????????
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