ÌÈÍÈÑÒÅÐÑÒÂÎ ÇÄÐÀÂÎÎÕÐÀÍÅÍÈß ÐÎÑÑÈÉÑÊÎÉ ÔÅÄÅÐÀÖÈÈ
ÏÐÈÊÀÇ
21 îêòÿáðÿ 2002 ã.
N 322
Î
ÏÐÈÌÅÍÅÍÈÈ Â ÏÐÀÊÒÈÊÅ ÇÄÐÀÂÎÎÕÐÀÍÅÍÈß
ÈÌÌÓÍÎÔÅÐÌÅÍÒÍÛÕ ÒÅÑÒ - ÑÈÑÒÅÌ ÄËß
ÂÛßÂËÅÍÈß
ÏÎÂÅÐÕÍÎÑÒÍÎÃÎ
ÀÍÒÈÃÅÍÀ ÂÈÐÓÑÀ ÃÅÏÀÒÈÒÀ Â (HBSAG)
È ÀÍÒÈÒÅË
Ê ÂÈÐÓÑÓ ÃÅÏÀÒÈÒÀ Ñ (ÀÍÒÈ-ÂÃÑ)
Â
ÑÛÂÎÐÎÒÊÅ ÊÐÎÂÈ ×ÅËÎÂÅÊÀ
 ñîîòâåòñòâèè ñ
ïëàíîì îðãàíèçàöèîííûõ ìåðîïðèÿòèé
Ìèíçäðàâà
Ðîññèè íà 2002 ãîä, à
òàêæå â öåëÿõ ïðèíÿòèÿ äîïîëíèòåëüíûõ ìåð ïî
ïðîòèâîäåéñòâèþ
ðàñïðîñòðàíåíèÿ âèðóñíûõ ãåïàòèòîâ
è óëó÷øåíèþ
êà÷åñòâà èììóíîáèîëîãè÷åñêèõ ïðåïàðàòîâ, ïðåäíàçíà÷åííûõ äëÿ
ëàáîðàòîðíîé äèàãíîñòèêè
âèðóñíûõ ãåïàòèòîâ Â è Ñ â
ïåðèîä ñ
01 èþíÿ ïî
1 àâãóñòà 2002
ãîäà áûëè ïðîâåäåíû ñðàâíèòåëüíûå
èñïûòàíèÿ äèàãíîñòè÷åñêèõ èììóíîôåðìåíòíûõ
òåñò - ñèñòåì äëÿ
âûÿâëåíèÿ ïîâåðõíîñòíîãî àíòèãåíà âèðóñà ãåïàòèòà
 (HBsAg) è
àíòèòåë ê âèðóñó
ãåïàòèòà Ñ (àíòè-ÂÃÑ) â ñûâîðîòêå êðîâè ÷åëîâåêà.
Ïî ðåçóëüòàòàì
èñïûòàíèé óñòàíîâëåíî, ÷òî çà ïåðèîä
ïðîøåäøèé
ñî âðåìåíè ïðîâåäåíèÿ
ïðåäûäóùèõ ñðàâíèòåëüíûõ èñïûòàíèé, êà÷åñòâî
îòå÷åñòâåííûõ äèàãíîñòè÷åñêèõ òåñò - ñèñòåì
çíà÷èòåëüíî
óëó÷øèëîñü, èõ
÷óâñòâèòåëüíîñòü ïîâûñèëàñü â
2 ðàçà. Àíàëèç
ðåçóëüòàòîâ èñïûòàíèé âûÿâèë
ïîòåíöèàëüíûå âîçìîæíîñòè
îòå÷åñòâåííûõ
ïðîèçâîäèòåëåé òåñò - ñèñòåì äëÿ äèàãíîñòèêè HBsAg è
àíòè-ÂÃÑ îáåñïå÷èòü
èõ åùå áîëåå âûñîêóþ ÷óâñòâèòåëüíîñòü è
ñïåöèôè÷íîñòü.
Íà îñíîâàíèè çàêëþ÷åíèÿ
êîìèññèè ïî îðãàíèçàöèè è ïðîâåäåíèþ
ñðàâíèòåëüíûõ
èñïûòàíèé òåñò - ñèñòåì äëÿ âûÿâëåíèÿ ïîâåðõíîñòíîãî
àíòèãåíà âèðóñà
ãåïàòèòà Â (HBsAg) è àíòèòåë ê âèðóñó ãåïàòèòà Ñ
(àíòè-ÂÃÑ) â
ñûâîðîòêå êðîâè ÷åëîâåêà,
â öåëÿõ ïðèíÿòèÿ
äîïîëíèòåëüíûõ ìåð
ïî ïðåäîòâðàùåíèþ ðàñïðîñòðàíåíèÿ âèðóñà
ãåïàòèòà Â è Ñ ïðè
ïåðåëèâàíèè
øåíèÿ êà÷åñòâà
ëàáîðàòîðíîé äèàãíîñòèêè âèðóñíûõ ãåïàòèòîâ Â è Ñ
------------------------------------------------------------------
Òåêñò äîêóìåíòà
ïðèâîäèòñÿ â ñîîòâåòñòâèè ñ îðèãèíàëîì.
------------------------------------------------------------------
ÏÐÈÊÀÇÛÂÀÞ:
1. Ðóêîâîäèòåëÿì
îðãàíîâ óïðàâëåíèÿ çäðàâîîõðàíåíèåì ñóáúåêòîâ
Ðîññèéñêîé Ôåäåðàöèè:
1.1. Îáåñïå÷èòü
ïðîâåäåíèå îáñëåäîâàíèÿ äîíîðîâ êðîâè, äîíîðîâ
îðãàíîâ è
òêàíåé ÷åëîâåêà, áîëüíûõ
îñòðûìè è õðîíè÷åñêèìè
ãåïàòèòàìè, à
òàê æå êîíòèíãåíòîâ
ïðåäóñìîòðåííûõ ÑÏ 3.1.958-99
"Ïðîôèëàêòèêà
âèðóñíûõ ãåïàòèòîâ. Îáùèå
òðåáîâàíèÿ ê
ýïèäåìèîëîãè÷åñêîìó íàäçîðó çà
âèðóñíûìè ãåïàòèòàìè" íà íàëè÷èå
HBsAg è
àíòè-ÂÃÑ ñ ïîìîùüþ
òåñò - ñèñòåì, óêàçàííûõ â
ïðèëîæåíèÿõ 1 è 3.
1.2.
Çàïðåòèòü ê ïðèìåíåíèþ
äèàãíîñòè÷åñêèå ïðåïàðàòû,
ñîäåðæàùèå â
êà÷åñòâå õðîìîãåíà (ñóáñòðàòà)
îðòîôåíèëåíäèàìèï
(ÎÔÄ), êîòîðûé ÿâëÿåòñÿ âûñîêîàêòèâíûì
êàíöåðîãåíîì, îïàñíûì äëÿ
çäîðîâüÿ ëþäåé è
òðåáóþùèì ñïåöèàëüíîé òåõíîëîãèè óòèëèçàöèè.
1.3.
Çàïðåòèòü ñ 1 ÿíâàðÿ 2004
ãîäà ê ïðèìåíåíèþ
äèàãíîñòè÷åñêèå òåñò
- ñèñòåìû äëÿ
ïîäòâåðæäåíèÿ àíòè-HCV,
ñîäåðæàùèå íåïîëíûé
ñïåêòð ñòðóêòóðíûõ è íåñòðóêòóðíûõ áåëêîâ HCV.
1.4. Èñêëþ÷èòü, íà÷èíàÿ
ñ 1 îêòÿáðÿ 2003 ãîäà
âîçìîæíîñòü
ïðèìåíåíèÿ â ïðàêòèêå
çäðàâîîõðàíåíèÿ òåñò - ñèñòåì äëÿ
âûÿâëåíèÿ
HBsAg ñ
÷óâñòâèòåëüíîñòüþ õóæå 0.1 íã/ìë (Ìå/ìë).
1.5.
Âðåìåííî, äî ïðîâåäåíèÿ
ïåðåàòòåñòàöèè, ïðèîñòàíîâèòü
ïðèìåíåíèå äèàãíîñòè÷åñêèõ ïðåïàðàòîâ äëÿ âûÿâëåíèÿ
HBsAg è
àíòèòåë ê âèðóñó
ãåïàòèòà Ñ (HCV), óêàçàííûõ â ïðèëîæåíèÿõ 5 è 6.
1.6.  ñëó÷àå
óñòàíîâëåíèÿ ôàêòîâ ïîñòàâêè òåñò - ñèñòåì äëÿ
âûÿâëåíèÿ HBsAg è
àíòè-ÂÃÑ íåóäîâëåòâîðèòåëüíîãî êà÷åñòâà, à òàêæå
íåñîáëþäåíèÿ óñëîâèé
èõ òðàíñïîðòèðîâêè è
õðàíåíèÿ,
íåçàìåäëèòåëüíî íàïðàâëÿòü èíôîðìàöèþ â Äåïàðòàìåíò
ãîññàíýïèäíàäçîðà Ìèíçäðàâà
Ðîññèè è ÃÈÑÊ
èì. Ë.À.Òàðàñåâè÷à
Ìèíçäðàâà Ðîññèè.
1.7. Èñïîëüçîâàòü äëÿ ïðîâåäåíèÿ àíàëèçà
ïî ïîäòâåðæäåíèþ
íàëè÷èÿ HBsAg
è àíòè-ÂÃÑ êîíôèðìàòîðíûå òåñò - ñèñòåìû
(ïðèëîæåíèÿ 2 è
4). Ïîñòàíîâêà îêîí÷àòåëüíîãî ëàáîðàòîðíîãî
äèàãíîçà áåç
ïîäòâåðæäåíèÿ â îäíîì
èç êîíôèðìàòîðíûõ òåñòîâ
çàïðåùàåòñÿ.
1.8. Äëÿ ïîäòâåðæäåíèÿ ïîëîæèòåëüíîãî
ðåçóëüòàòà ÈÔÀ íà
íàëè÷èå àíòèòåë ê
âèðóñó ãåïàòèòà Ñ (HCV) ïðè îáñëåäîâàíèè äîíîðîâ
êðîâè, äîíîðîâ
îðãàíîâ è òêàíåé ÷åëîâåêà
ðàçðåøèòü èñïîëüçîâàòü
äèàãíîñòè÷åñêèå ïðåïàðàòû
óêàçàííûå â ïðèëîæåíèè 4 (N 6/2
è
N 16/4).
1.9. Èñêëþ÷èòü
èñïîëüçîâàíèå äèàãíîñòè÷åñêèõ
èììóíîôåðìåíòíûõ
òåñò -
ñèñòåì äëÿ âûÿâëåíèÿ
HBsAg è àíòè-ÂÃÑ,
íå èìåþùèõ
ðàçðåøåíèå Ìèíçäðàâà
Ðîññèè íà ïðèìåíåíèå.
2. Ãëàâíûì âðà÷àì
Öåíòðîâ ãîññàíýïèäíàäçîðà â
ñóáúåêòàõ
Ðîññèéñêîé Ôåäåðàöèè:
2.1.
Îáåñïå÷èòü äåéñòâåííûé êîíòðîëü
çà èñïîëüçîâàíèåì íà
ìåñòàõ òåñò - ñèñòåì
äëÿ âûÿâëåíèÿ HBsAg è àíòè-ÂÃÑ â ñîîòâåòñòâèè
ñ íàñòîÿùèì ïðèêàçîì.
2.2.  ñëó÷àå
ïðèìåíåíèÿ äëÿ äèàãíîñòèêè HBsAg è àíòè-ÂÃÑ òåñò
- ñèñòåì, íå
ðàçðåøåííûõ Ìèíçäðàâîì Ðîññèè, ïðèíèìàòü ñðî÷íûå ìåðû
ïî èõ
çàïðåùåíèþ. Î êàæäîì
âûÿâëåííîì ñëó÷àå íåìåäëåííî
èíôîðìèðîâàòü
Äåïàðòàìåíò ãîññàíýïèäíàäçîðà Ìèíçäðàâà Ðîññèè.
2.3.
Îáåñïå÷èòü ïîñòîÿííûé êîíòðîëü
çà òðàíñïîðòèðîâêîé è
õðàíåíèåì òåñò
- ñèñòåì äëÿ
äèàãíîñòèêè HBsAg è
àíòè-ÂÃÑ â
ñîîòâåòñòâèè ñ
èíñòðóêöèÿìè ïî ïðèìåíåíèþ è òðåáîâàíèÿìè
ñàíèòàðíûõ ïðàâèë ÑÏ 3.3.2.028-95 "Óñëîâèÿ òðàíñïîðòèðîâêè è
õðàíåíèÿ ìåäèöèíñêèõ
èììóíîáèîëîãè÷åñêèõ ïðåïàðàòîâ".
3. Äåïàðòàìåíòó
ãîññàíýïèäíàäçîðà Ìèíçäðàâà Ðîññèè:
3.1. Äîâåñòè äî
ñâåäåíèÿ âñåõ ó÷àñòíèêîâ ñðàâíèòåëüíûõ
èñïûòàíèé äèàãíîñòè÷åñêèõ èììóíîôåðìåíòíûõ
òåñò - ñèñòåì
ðåçóëüòàòû èñïûòàíèé
(ïðèëîæåíèå 7).
3.2. Îðãàíèçîâàòü
è ïðîâåñòè ñëåäóþùèå ñðàâíèòåëüíûå èñïûòàíèÿ
â I-II êâàðòàëå 2004
ãîäà.
4.
Ãîñóäàðñòâåííîìó ÍÈÈ ñòàíäàðòèçàöèè è
êîíòðîëÿ ìåäèöèíñêèõ
èììóíîáèîëîãè÷åñêèõ
ïðåïàðàòîâ èì. Ë.À.Òàðàñåâè÷à Ìèíçäðàâà
Ðîññèè:
4.1. Ïðîâåñòè
ïåðåàòòåñòàöèþ òåñò - ñèñòåì, ðåçóëüòàòû êîòîðûõ
îêàçàëèñü íåóäîâëåòâîðèòåëüíûìè, ñ
ïðèìåíåíèåì êîíòðîëüíûõ
ïàíåëåé,
èñïîëüçîâàííûõ â ñðàâíèòåëüíûõ èñïûòàíèÿõ.
4.2.
Ðåçóëüòàòû ïåðåàòòåñòàöèè ïðåäñòàâèòü â Ìèíçäðàâ Ðîññèè
äî 01 ôåâðàëÿ 2003 ã.
5. Êîíòðîëü çà
âûïîëíåíèåì íàñòîÿùåãî ïðèêàçà âîçëîæèòü íà
Ïåðâîãî çàìåñòèòåëÿ
Ìèíèñòðà Ã.Ã.Îíèùåíêî.
Ìèíèñòð
Þ.Ë.ØÅÂ×ÅÍÊÎ
Ïðèëîæåíèå N
1
ê ïðèêàçó
Ìèíèñòåðñòâà
çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N
322
ÏÅÐÅ×ÅÍÜ
ÒÅÑÒ -
ÑÈÑÒÅÌ ÄËß ÂÛßÂËÅÍÈß ÏÎÂÅÐÕÍÎÑÒÍÎÃÎ
ÀÍÒÈÃÅÍÀ ÂÈÐÓÑÀ
ÃÅÏÀÒÈÒÀ Â (HBSAG) Â ÈÌÌÓÍÎÔÅÐÌÅÍÒÍÎÌ
ÌÅÒÎÄÅ,
ÐÀÇÐÅØÅÍÍÛÕ ÄËß ÎÁÑËÅÄÎÂÀÍÈß ÄÎÍÎÐÎÂ ÊÐÎÂÈ,
ÎÐÃÀÍÎÂ È
ÒÊÀÍÅÉ ×ÅËÎÂÅÊÀ, ÁÎËÜÍÛÕ ÎÑÒÐÛÌÈ È
ÕÐÎÍÈ×ÅÑÊÈÌÈ ÃÅÏÀÒÈÒÀÌÈ, ÑÊÐÈÍÈÍÃÀ
ÍÀÑÅËÅÍÈß
------------------------------------------------------------------
| Ïîðÿäêîâûé | Íàçâàíèå
òåñò - ñèñòåìû |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
|1. Òåñò -
ñèñòåìû| |
|îòêðûòîãî òèïà | |
|-----------------+----------------------------------------------|
| 7/0 |"Ãåïàñêàí HBsAg" |
|-----------------+----------------------------------------------|
| 6/0 |"Ìîíîëèçà Ag HBs Plus" |
|-----------------+----------------------------------------------|
| 9/2 |"Âåêòîãåï B-HBs-àíòèãåí" |
|-----------------+----------------------------------------------|
| 9/3 |"Âåêòîãåï B-HBs-àíòèãåí-ñòðèï" |
|-----------------+----------------------------------------------|
| 9/4 |"Beêòoãeï B-HBs-àíòèãåí" êîìïëåêò N 2 |
|-----------------+----------------------------------------------|
| 9/5 |"Âåêòîãåï B-HBs-àíòèãåí-ñòðèï" êîìïëåêò N 4 |
|-----------------+----------------------------------------------|
| 10/1 |"ÈÔÀ-HBsAg/M" íàáîð N 2 ÒÌÁ) |
|-----------------+----------------------------------------------|
| 12/0 |"ÈÔÀ-HBsAg" êîìïëåêò N 1 |
|-----------------+----------------------------------------------|
| 16/0 |"ÃåïàÑòðèï" |
|-----------------+----------------------------------------------|
| 16/1 |"Murex HBsAg Âåðñèÿ 3" |
|-----------------+----------------------------------------------|
| 16/2 |"ÃåïàÁëîê" |
|-----------------+----------------------------------------------|
| 20/0 |"ÈÔÀ-HBsAg" |
|-----------------+----------------------------------------------|
| 11/0 |DiaSorin
"ETI-MAK-4" ÈÔÀ(HBsAg)
|
|-----------------+----------------------------------------------|
| 23/3 |"ÝÊÎëàá-ÐÅÊÎÌÀÒÃÅÏ Â" |
|-----------------+----------------------------------------------|
| 4/0 <*> |"Èììóíîêîìá II HbsAg 90" |
|-----------------+----------------------------------------------|
|2. Òåñò -
ñèñòåìû| |
|çàêðûòîãî òèïà |
|
|-----------------+----------------------------------------------|
| 5/1 |"VIDAS HBsAg" |
|-----------------+----------------------------------------------|
| 21/2
|"Elecsys HBsAg" |
|-----------------+----------------------------------------------|
| 21/3 |"HBsAg II EIA Cobas core" |
|-----------------+----------------------------------------------|
| 22/0 |"AxSYM HBsAg (V2)" |
|-----------------+----------------------------------------------|
| 22/1 |"IMX system HBsAg (V2)" |
|-----------------+----------------------------------------------|
| 17/1 |"IMMULITE HBsAg" |
------------------------------------------------------------------
--------------------------------
<*>
Äèàãíîñòè÷åñêèé ïðåïàðàò
"Èììóíîêîìá II HBsAg90" ìîæåò
èñïîëüçîâàòüñÿ äëÿ
îáñëåäîâàíèÿ äîíîðîâ êðîâè,
îðãàíîâ òêàíåé è
÷åëîâåêà òîëüêî
â óðãåíòíûõ ñèòóàöèÿõ
èëè ïðè îòñóòñòâèè
ëàáîðàòîðíîãî îáîðóäîâàíèÿ, êîãäà íåâîçìîæíî èñïîëüçîâàíèå äëÿ
ýòèõ öåëåé äðóãèõ
ïðåïàðàòîâ, óêàçàííûõ â ïðèëîæåíèè 1.
Çàìåñòèòåëü
ðóêîâîäèòåëÿ
Äåïàðòàìåíòà
ãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ
Ïðèëîæåíèå N
2
ê
ïðèêàçó
Ìèíèñòåðñòâà
çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N
322
ÏÅÐÅ×ÅÍÜ
ÒÅÑÒ -
ÑÈÑÒÅÌ, ÏÐÅÄÍÀÇÍÀ×ÅÍÍÛÕ ÄËß ÏÎÄÒÂÅÐÆÄÅÍÈß
ÍÀËÈ×Èß HBSAG
------------------------------------------------------------------
| Ïîðÿäêîâûé | Íàçâàíèå
òåñò - ñèñòåìû |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
| 10/2 |"ÈÔÀ-HBsAg ïîäòâåðæä. òåñò |
|-----------------+----------------------------------------------|
| 7/2
|"Ãåïàñêàí HBsAg
ïîäòâ." |
|-----------------+----------------------------------------------|
| 23/0 |"ÝÊÎëàá-ÐÅÊÎÌÀÒÃÅÏ Â-ïîäòâ." |
|-----------------+----------------------------------------------|
| 9/6 |"Ðåêîìàòãåï-Â-ïîäòâ. òåñò" |
|-----------------+----------------------------------------------|
| 9/7 |"Âåêòîãåï B-HBs-àíòèãåí ïîäòâ. òåñò -
ñòðèï" |
| |êîìïëåêò 5 |
|-----------------+----------------------------------------------|
| 9/8 |"Âåêòîãåï B-HBs-àíòèãåí ïîäòâ. òåñò -
ñòðèï" |
| |êîìïëåêò 6 |
|-----------------+----------------------------------------------|
| 12/3 |"ÈÔÀ-HBsAg" êîìïëåêò N 2 |
|-----------------+----------------------------------------------|
| 6/1 |"Ìîíîëèçà HBsAg confirmatory" |
|-----------------+----------------------------------------------|
| 11/2 |"Reak-801" |
|-----------------+----------------------------------------------|
| 5/3 |"VIDAS HBsAg confirmation" |
|-----------------+----------------------------------------------|
| 21/0 |Elecsys HBsAg confirmatory" |
|-----------------+----------------------------------------------|
| 21/1
|"Cobas core HBsAg EIA
confirmatory" |
|-----------------+----------------------------------------------|
| 22/2 |"AxSYM HBsAg confirmatory" |
|-----------------+----------------------------------------------|
| 22/3 |"IMX HBsAg confirmatory" |
|-----------------+----------------------------------------------|
| 17/0 |"IMMULITE HBsAg confirmatory" |
------------------------------------------------------------------
Çàìåñòèòåëüðóêîâîäèòåëÿ
Äåïàðòàìåíòàãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ
Ïðèëîæåíèå N
3
ê ïðèêàçó
Ìèíèñòåðñòâà
çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N
322
ÏÅÐÅ×ÅÍÜ
ÒÅÑÒ -
ÑÈÑÒÅÌ ÄËß ÂÛßÂËÅÍÈß ÀÍÒÈÒÅË Ê ÂÈÐÓÑÓ
ÃÅÏÀÒÈÒÀ Ñ Â
ÈÌÌÓÍÎÔÅÐÌÅÍÒÍÎÌ ÌÅÒÎÄÅ, ÐÀÇÐÅØÅÍÍÛÕ
ÄËß
ÎÁÑËÅÄÎÂÀÍÈß ÄÎÍÎÐÎÂ ÊÐÎÂÈ, ÎÐÃÀÍÎÂ È ÒÊÀÍÅÉ
×ÅËÎÂÅÊÀ, ÁÎËÜÍÛÕ
ÎÑÒÐÛÌÈ È ÕÐÎÍÈ×ÅÑÊÈÌÈ ÃÅÏÀÒÈÒÀÌÈ
È ÑÊÐÈÍÈÍÃÀ ÍÀÑÅËÅÍÈß
------------------------------------------------------------------
| Ïîðÿäêîâûé | Íàçâàíèå
òåñò - ñèñòåìû |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
|1. Òåñò -
ñèñòåìû| |
|îòêðûòîãî òèïà | |
|-----------------+----------------------------------------------|
| 1/0 |"ÂÃÑ-ÈÔÀ-Àâèöåííà" |
|-----------------+----------------------------------------------|
| 2/2 |"Àêâàãåï-Ñ" |
|-----------------+----------------------------------------------|
| 6/3 |"Monolisa anti-HCV" |
|-----------------+----------------------------------------------|
| 7/1 |"Ãåïàñêðèí" |
|-----------------+----------------------------------------------|
| 8/4 |"Àíòè-ÂÃÑ-ÈÔÀ" |
|-----------------+----------------------------------------------|
| 9/9 |"ÐåêîìáèÁåñò-àíòè-ÂÃÑ" |
|-----------------+----------------------------------------------|
| 9/10 |"ÐåêîìáèÁåñò-àíòè-ÂÃÑ-ñòðèï" |
|-----------------+----------------------------------------------|
| 10/4 |"ÈÔÀ-antiHCV" (ÒÌÁ) |
|-----------------+----------------------------------------------|
| 12/1 |"ÈÔÀ-àíòè-ÂÃÑ" |
|-----------------+----------------------------------------------|
| 13/2 |"ÂÃÑ-ÄÑÌ (êîìïëåêò 1)" |
|-----------------+----------------------------------------------|
| 14/0 |"ÂÃÑ-êîíòðîëü Ä.Ì." |
|-----------------+----------------------------------------------|
| 16/3 |"Murex-anti-HCV" |
|-----------------+----------------------------------------------|
| 19/1 |"ÈÔÀ-àíòè-ÂÃÑ" |
|-----------------+----------------------------------------------|
| 23/1 |"ÝÊÎëàá-ÂÃÑ" |
|-----------------+----------------------------------------------|
| 4/1 <*> |"Èììóíîêîìá II HCV" |
|-----------------+----------------------------------------------|
|2. Òåñò -
ñèñòåìû| |
|çàêðûòîãî òèïà | |
|-----------------+----------------------------------------------|
| 21/4 |"Cobas core anti-HCV EIA" |
|-----------------+----------------------------------------------|
| 22/4 |"AxSYM HCV (V3)" |
|-----------------+----------------------------------------------|
| 22/5 |"IMX HCV (V3)" |
------------------------------------------------------------------
--------------------------------
<*>
Äèàãíîñòè÷åñêèé ïðåïàðàò "Èììóíîêîìá II HCV" ìîæåò
èñïîëüçîâàòüñÿ äëÿ
îáñëåäîâàíèÿ äîíîðîâ êðîâè,
îðãàíîâ òêàíåé è
÷åëîâåêà òîëüêî
â óðãåíòíûõ ñèòóàöèÿõ
èëè ïðè îòñóòñòâèè
ëàáîðàòîðíîãî
îáîðóäîâàíèÿ, êîãäà íåâîçìîæíî
èñïîëüçîâàíèå äëÿ
ýòèõ öåëåé äðóãèõ
ïðåïàðàòîâ, óêàçàííûõ â ïðèëîæåíèè 3.
Çàìåñòèòåëü
ðóêîâîäèòåëÿ
Äåïàðòàìåíòà
ãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ
Ïðèëîæåíèå N
4
ê
ïðèêàçó
Ìèíèñòåðñòâà
çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N
322
ÏÅÐÅ×ÅÍÜ
ÒÅÑÒ -
ÑÈÑÒÅÌ, ÏÐÅÄÍÀÇÍÀ×ÅÍÍÛÕ ÄËß ÎÏÐÅÄÅËÅÍÈß
ÑÏÅÊÒÐÀ ÀÍÒÈÒÅË Ê ÑÒÐÓÊÒÓÐÍÛÌ È
ÍÅÑÒÐÓÊÒÓÐÍÛÌ
ÁÅËÊÀÌ ÂÈÐÓÑÀ ÃÅÏÀÒÈÒÀ Ñ
(ÏÎÄÒÂÅÐÆÄÀÞÙÈÅ ÒÅÑÒÛ)
------------------------------------------------------------------
| Ïîðÿäêîâûé | Íàçâàíèå
òåñò - ñèñòåìû |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
| 10/6
|"ÈÔÀ-antiHCV-ñïåêòð
GM" (ÒÌÁ) |
|-----------------+----------------------------------------------|
| 12/2 |"Ñïåêòð-4" |
|-----------------+----------------------------------------------|
| 23/2 |"ÝÊÎëàá-ÂÃÑ-ïîäòâåðæäàþùèé òåñò" |
|-----------------+----------------------------------------------|
| 9/11 |"ÐåêîìáèÁåñò-àíòè-ÂÃÑ-ñïåêòð" |
|-----------------+----------------------------------------------|
| 9/12 |"ÐåêîìáèÁåñò-àíòè-ÂÃÑ-ïîäòâåðæäàþùèé òåñò" |
|-----------------+----------------------------------------------|
| 13/3 |"ÂÃÑ-ÄÑÌ ïîäòâåðæä. (êîìïëåêò N 1)" |
|-----------------+----------------------------------------------|
| 13/4 |"ÂÃÑ-ÄÑÌ ïîäòâåðæä. (êîìïëåêò N 2)" |
|-----------------+----------------------------------------------|
| 6/2 |"Deciscan anti-HCV" <*> |
|-----------------+----------------------------------------------|
| 16/4 |"INNO-LIA HCV Ab III update)" |
------------------------------------------------------------------
--------------------------------
<*> Òåñò -
ñèñòåìà íå ñîäåðæèò NS5.
Çàìåñòèòåëü
ðóêîâîäèòåëÿ
Äåïàðòàìåíòà
ãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ
Ïðèëîæåíèå N
5
ê
ïðèêàçó
Ìèíèñòåðñòâà
çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N
322
ÏÅÐÅ×ÅÍÜ
ÒÅÑÒ - ÑÈÑÒÅÌ
ÄËß ÂÛßÂËÅÍÈß È ÏÎÄÒÂÅÐÆÄÅÍÈß HBSAG,
ÐÅÇÓËÜÒÀÒÛ
ÑÐÀÂÍÈÒÅËÜÍÛÕ ÈÑÏÛÒÀÍÈÉ ÊÎÒÎÐÛÕ ÎÊÀÇÀËÈÑÜ
ÍÅÓÄÎÂËÅÒÂÎÐÈÒÅËÜÍÛÌÈ È ÈÑÏÎËÜÇÎÂÀÍÈÅ ÊÎÒÎÐÛÕ
ÂÐÅÌÅÍÍÎ ÏÐÈÎÑÒÀÍÀÂËÈÂÀÅÒÑß
------------------------------------------------------------------
| Ïîðÿäêîâûé | Íàçâàíèå
òåñò - ñèñòåìû |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
| 2/0 |"Ãåïàòàã-Â-1" |
|-----------------+----------------------------------------------|
| 2/1 |"Ãåïàòàã-Â/ì-4" |
|-----------------+----------------------------------------------|
| 19/0
|"ÈÔÀ-ÍÂs-àíòèãåí" êîìïëåêò N 1 |
|-----------------+----------------------------------------------|
| 19/2 |"ÈÔÀ-ÍÂs-àíòèãåí" êîìïëåêò N 2 |
|-----------------+----------------------------------------------|
| 8/0 |"Ðåêîìàòãåï-Â" |
|-----------------+----------------------------------------------|
| 8/1 |"Ðåêîìàòãåï-Â ñòðèï" |
|-----------------+----------------------------------------------|
| 8/2 |"Ðåêîìàòãåï-Â-ïîäòâ." |
|-----------------+----------------------------------------------|
| 9/0 |"Ðåêîìàòãåï-Â ñòðèï" |
|-----------------+----------------------------------------------|
| 9/1 |"Ðåêîìàòãåï-Â" |
|-----------------+----------------------------------------------|
| 15/0 |"HBsAg-ÈÔÀ-Ì" |
|-----------------+----------------------------------------------|
| 5/2 |"Ãåïàíîñòèêà HBsAg Uni-Form II" |
|-----------------+----------------------------------------------|
| 5/0 |"Ãåïàíîñòèêà HBsAg Uni-Form II ïîäòâ." |
------------------------------------------------------------------
Çàìåñòèòåëü
ðóêîâîäèòåëÿ
Äåïàðòàìåíòà
ãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ
Ïðèëîæåíèå N
6
ê
ïðèêàçó
Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N
322
ÏÅÐÅ×ÅÍÜ
ÒÅÑÒ - ÑÈÑÒÅÌ
ÄËß ÂÛßÂËÅÍÈß È ÏÎÄÒÂÅÐÆÄÅÍÈß ÀÍÒÈÒÅË
Ê ÂÈÐÓÑÓ
ÃÅÏÀÒÈÒÀ Ñ, ÐÅÇÓËÜÒÀÒÛ ÑÐÀÂÍÈÒÅËÜÍÛÕ
ÈÑÏÛÒÀÍÈÉ
ÊÎÒÎÐÛÕ ÎÊÀÇÀËÈÑÜ ÍÅÓÄÎÂËÅÒÂÎÐÈÒÅËÜÍÛÌÈ È
ÈÑÏÎËÜÇÎÂÀÍÈÅ
ÊÎÒÎÐÛÕ ÂÐÅÌÅÍÍÎ ÏÐÈÎÑÒÀÍÀÂËÈÂÀÅÒÑß
------------------------------------------------------------------
| Ïîðÿäêîâûé | Íàçâàíèå
òåñò - ñèñòåìû |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
| 8/3 |"Àíòè-ÂÃÑ-ÈÔÀ-ñòðèï" |
|-----------------+----------------------------------------------|
| 8/5 |"Àíòè-ÂÃÑ-ÈÔÀ-ïîäòâ. òåñò" |
|-----------------+----------------------------------------------|
| 20/1 |"ÈÔÀ-àíòè-HCV" |
|-----------------+----------------------------------------------|
| 2/3 |"Àêâàñïåêòð-Ñ" |
|-----------------+----------------------------------------------|
| 10/5 |"ÈÔÀ-antiHCV-ñïåêòð" (ÒÌÁ) |
------------------------------------------------------------------
Çàìåñòèòåëü ðóêîâîäèòåëÿ
Äåïàðòàìåíòà
ãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ
Ïðèëîæåíèå N
7
ê
ïðèêàçó
Ìèíèñòåðñòâà
çäðàâîîõðàíåíèÿ
Ðîññèéñêîé
Ôåäåðàöèè
îò 21.10.2002 ã. N 322
ÏÅÐÅ×ÅÍÜ
ÄÈÀÃÍÎÑÒÈ×ÅÑÊÈÕ ÒÅÑÒ - ÑÈÑÒÅÌ È ÈÕ ÏÐÎÈÇÂÎÄÈÒÅËÅÉ,
ÏÐÈÍßÂØÈÕ
Ó×ÀÑÒÈÅ Â ÑÐÀÂÍÈÒÅËÜÍÛÕ ÈÑÏÛÒÀÍÈßÕ
------------------------------------------------------------------
| Ïîðÿäêîâûé | Ôèðìà -
ïðîèçâîäèòåëü |
| íîìåð â õîäå | |
| èñïûòàíèé | |
|-----------------+----------------------------------------------|
| 1/0 |ÎÎÎ ÌÖ "Àâèöåííà" |
|-----------------+----------------------------------------------|
| 2/0 |ÎÎÎ "ÍÏÏ Àêâàïàñò" |
|-----------------+----------------------------------------------|
| 2/1 |ÎÎÎ "ÍÏÏ Àêâàïàñò" |
|-----------------+----------------------------------------------|
| 2/2 |ÎÎÎ "ÍÏÏ Àêâàïàñò" |
|-----------------+----------------------------------------------|
| 2/3 |ÎÎÎ "ÍÏÏ Àêâàïàñò" |
|-----------------+----------------------------------------------|
| 3/0 |ÎÎÎ "Àìåðêàðä" <*> "Àìåðêàðä
HBsAg" |
|-----------------+----------------------------------------------|
| 4/0 |ÇÀÎ "Áèîãðàä" |
|-----------------+----------------------------------------------|
| 4/1 |ÇÀÎ
"Áèîãðàä" |
|-----------------+----------------------------------------------|
| 5/0 |ÎÎÎ "Áèîìåðüå" |
|-----------------+----------------------------------------------|
| 5/1 |ÎÎÎ "Áèîìåðüå" |
|-----------------+----------------------------------------------|
| 5/2 |ÎÎÎ "Áèîìåðüå" |
|-----------------+----------------------------------------------|
| 5/3 |ÎÎÎ "Áèîìåðüå" |
|-----------------+----------------------------------------------|
| 6/0 |"Áèî-Ðàä" |
|-----------------+----------------------------------------------|
| 6/1 |"Áèî-Ðàä" |
|-----------------+----------------------------------------------|
| 6/2 |"Áèî-Ðàä" |
|-----------------+----------------------------------------------|
| 6/3 |"Áèî-Ðàä" |
|-----------------+----------------------------------------------|
| 7/0 |ÇÀÎ ÁÊ "Áèîñåðâèñ" |
|-----------------+----------------------------------------------|
| 7/1 |ÇÀÎ ÁÊ "Áèîñåðñèñ" |
|-----------------+----------------------------------------------|
| 7/2 |ÇÀÎ ÁÊ "Áèîñåðâèñ" |
|-----------------+----------------------------------------------|
| 7/3 |ÇÀÎ ÁÊ "Áèîñåðâèñ" <*> "ÁËÎÒ
HCV" |
|-----------------+----------------------------------------------|
| 8/0 |ÃÍÖ ÂÁ "Âåêòîð" |
|-----------------+----------------------------------------------|
| 8/1 |ÃÍÖ ÂÁ "Âåêòîð" |
|-----------------+----------------------------------------------|
| 8/2 |ÃÍÖ ÂÁ "Âåêòîð" |
|-----------------+----------------------------------------------|
| 8/3 |ÃÍÖ ÂÁ "Âåêòîð" |
|-----------------+----------------------------------------------|
| 8/4 |ÃÍÖ ÂÁ "Âåêòîð" |
|-----------------+----------------------------------------------|
| 8/5 |ÃÍÖ ÂÁ "Âåêòîð" |
|-----------------+----------------------------------------------|
| 9/0 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/1 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/2 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/3 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/4 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/5 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/6 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/7 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/8 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/9 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/10 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/11 |ÇÀÎ "Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/12 |ÇÀÎ
"Âåêòîð-Áåñò" |
|-----------------+----------------------------------------------|
| 9/13 |ÇÀÎ "Âåêòîð-Áåñò" <*>
"ÂÃÑ-ýêñïðåññ" |
|-----------------+----------------------------------------------|
| 10/0 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 10/1 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 10/2 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 10/3 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 10/4 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 10/5 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 10/6 |ÍÏÎ "Äèàãíîñòè÷åñêèå ñèñòåìû" |
|-----------------+----------------------------------------------|
| 11/0 |"DiaSorin S.r.l." |
|-----------------+----------------------------------------------|
| 11/1 |"DiaSorin Sri" <*>
"ETI-AB-HCVK-3" |
|-----------------+----------------------------------------------|
| 11/2
|"DiaSorin
S.r.l."
|
|-----------------+----------------------------------------------|
| 12/0 |"ÈìÁèî" |
|-----------------+----------------------------------------------|
| 12/1 |"ÈìÁèî" |
|-----------------+----------------------------------------------|
| 12/2 |"ÈìÁèî" |
|-----------------+----------------------------------------------|
| 12/3 |"ÈìÁèî" |
|-----------------+----------------------------------------------|
| 13/0 |ÇÀÎ "Ìåäèêî - áèîëîãè÷åñêèé ñîþç" <*> |
| |"HBs-àíòèãåí-ÄÑ" |
|-----------------+----------------------------------------------|
| 13/1 |ÇÀÎ "Ìåäèêî - áèîëîãè÷åñêèé ñîþç" <*> |
| |"HBs-àíòèãåí-ÄÑ-ñòðèï -
ïîäòâåðæäàþùèé" |
|-----------------+----------------------------------------------|
| 13/2 |ÇÀÎ "Ìåäèêî - áèîëîãè÷åñêèé ñîþç" |
|-----------------+----------------------------------------------|
| 13/3 |ÇÀÎ "Ìåäèêî - áèîëîãè÷åñêèé ñîþç" |
|-----------------+----------------------------------------------|
| 13/4 |ÇÀÎ "Ìåäèêî - áèîëîãè÷åñêèé ñîþç" |
|-----------------+----------------------------------------------|
| 14/0 |ÏÊÁ èì. È.È.Ìå÷íèêîâà |
|-----------------+----------------------------------------------|
| 15/0 |ÎÎÎ ÁÌÔ "Ìóëüòèòåñò" |
|-----------------+----------------------------------------------|
| 16/0 |ÇÀÎ "Íèàðìåäèê ïëþñ" |
|-----------------+----------------------------------------------|
| 16/1 |ÇÀÎ "Íèàðìåäèê ïëþñ" |
|-----------------+----------------------------------------------|
| 16/2 |ÇÀÎ "Íèàðìåäèê ïëþñ" |
|-----------------+----------------------------------------------|
| 16/3 |ÇÀÎ "Íèàðìåäèê ïëþñ" |
|-----------------+----------------------------------------------|
| 16/4 |ÇÀÎ "Íèàðìåäèê ïëþñ" |
|-----------------+----------------------------------------------|
| 17/0 |ÎÎÎ "ÎÌÁ" |
|-----------------+----------------------------------------------|
| 17/1 |ÎÎÎ "ÎÌÁ" |
|-----------------+----------------------------------------------|
| 18/0 |"ORTHO" <*> "HBsAg ELISA" |
|-----------------+----------------------------------------------|
| 18/1 |"ORTHO" <*> "HCV ELISA" |
|-----------------+----------------------------------------------|
| 18/2 |"ORTHO
<*> "CHIRON RIBA HCV 3.0" |
|-----------------+----------------------------------------------|
| 19/0 |ÍÈÈ ýïèäåìèîëîãèè è ìèêðîáèîëîãèè èì. Ïàñòåðà |
|-----------------+----------------------------------------------|
| 19/1 |ÍÈÈ ýïèäåìèîëîãèè è ìèêðîáèîëîãèè èì. Ïàñòåðà |
|-----------------+----------------------------------------------|
| 19/2 |ÍÈÈ ýïèäåìèîëîãèè è ìèêðîáèîëîãèè èì. Ïàñòåðà |
|-----------------+----------------------------------------------|
| 20/0 |ÍÏÊ "Ïðåïàðàò" |
|-----------------+----------------------------------------------|
| 20/1 |ÍÏÊ "Ïðåïàðàò" |
|-----------------+----------------------------------------------|
| 21/0 |ÇÀÎ "Ðîø-Ìîñêâà" |
|-----------------+----------------------------------------------|
| 21/1 |ÇÀÎ "Ðîø-Ìîñêâà" |
|-----------------+----------------------------------------------|
| 21/2 |ÇÀÎ "Ðîø-Ìîñêâà" |
|-----------------+----------------------------------------------|
| 21/3 |ÇÀÎ "Ðîø-Ìîñêâà" |
|-----------------+----------------------------------------------|
| 21/4 |ÇÀÎ "Ðîø-Ìîñêâà" |
|-----------------+----------------------------------------------|
| 22/0 |"Ýááîò ëàáîðàòîðèç Ñ.À." |
|-----------------+----------------------------------------------|
| 22/1 |"Ýááîò ëàáîðàòîðèç Ñ.À." |
|-----------------+----------------------------------------------|
| 22/2 |"Ýááîò ëàáîðàòîðèç Ñ.À." |
|-----------------+----------------------------------------------|
| 22/3 |"Ýááîò ëàáîðàòîðèç Ñ.À." |
|-----------------+----------------------------------------------|
| 22/4 |"Ýááîò ëàáîðàòîðèç Ñ.À." |
|-----------------+----------------------------------------------|
| 22/5 |"Ýááîò ëàáîðàòîðèç Ñ.À." |
|-----------------+----------------------------------------------|
| 23/0 |ÎÎÎ "Ýêîëàá" |
|-----------------+----------------------------------------------|
| 23/1 |ÎÎÎ "Ýêîëàá" |
|-----------------+----------------------------------------------|
| 23/2 |ÎÎÎ "Ýêîëàá" |
|-----------------+----------------------------------------------|
| 23/3 |ÎÎÎ "Ýêîëàá" |
------------------------------------------------------------------
--------------------------------
<*>
Ïðåïàðàòû íàõîäÿòñÿ íà ðåãèñòðàöèè â Ìèíçäðàâå Ðîññèè.
Çàìåñòèòåëü
ðóêîâîäèòåëÿ
Äåïàðòàìåíòà
ãîññàíýïèäíàäçîðà
Ì.Ï.ØÅÂÛÐÅÂÀ