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4> ?C1;VG=>W V=D>@<0FVW, B0/01> <VAB8BLAO C 2V4:@8B8E ?C1;VG=8E 5;5:B@>==8E @5TAB@0E, 4>ABC? 4> O:8E T 2V;L=8<, B0/01> <>65 1CB8 >B@8<0=0 5;5:B@>==>N A8AB5<>N 70:C?V25;L H;OE>< >1<V=C V=D>@<0FVTN 7 V=H8<8 45@602=8<8 A8AB5<0<8 B0 @5TAB@0<8.6=D>@<0FVO ?@> B5E=VG=V, O:VA=V B0 :V;L:VA=V E0@0:B5@8AB8:8 ?@54<5B0 70:C?V2;V#G0A=8:8 ?@>F54C@8 70:C?V2;V ?>28==V =040B8 C A:;04V ?@>?>78FVW V=D>@<0FVN B0 4>:C<5=B8, O:V ?V4B25@46CNBL 2V4?>2V4=VABL B5E=VG=8< (<548:>-B5E=VG=8<), O:VA=8<, :V;L:VA=8< B0 V=H8< 28<>30< 4> ?@54<5B0 70:C?V2;V, CAB0=>2;5=8< 70<>2=8:>< (>40B>: 3). "5E=VG=V, O:VA=V E0@0:B5@8AB8:8 ?@54<5B0 70:C?V2;V B0 B5E=VG=V A?5F8DV:0FVW 4> ?@54<5B0 70:C?V2;V ?>28==V 287=0G0B8AO 70<>2=8:>< 7 C@0EC20==O< 28<>3, 287=0G5=8E HYPERLINK "https://zakon.rada.gov.ua/laws/show/922-19" \l "n937" G0AB8=>N G5B25@B>NAB0BBV 5 FL>3> 0:>=C. # @07V =0O2=>ABV 2 ?@54<5BV 70:C?V2;V, 9>3> B5E=VG=8E B0 O:VA=8E E0@0:B5@8AB8:0E ?>A8;0=L =0 :>=:@5B=V <0@:C G8 28@>1=8:0 01> =0 :>=:@5B=89 ?@>F5A, I> E0@0:B5@87CT ?@>4C:B G8 ?>A;C3C ?52=>3> AC1 T:B0 3>A?>40@N20==O, G8 =0 B>@3>2V <0@:8, ?0B5=B8, B8?8 01> :>=:@5B=5 <VAF5 ?>E>465==O G8 A?>AV1 28@>1=8FB20 ?VA;O B0:>3> ?>A8;0==O A;V4 22060B8 2 =0O2=>ABV 28@07 01> 5:2V20;5=B.7=D>@<0FVO ?@> <0@:C20==O, ?@>B>:>;8 28?@>1C20=L 01> A5@B8DV:0B8, I> ?V4B25@46CNBL 2V4?>2V4=VABL ?@54<5B0 70:C?V2;V 2AB0=>2;5=8< 70<>2=8:>< 28<>30< (C @07V ?>B@518)0<>2=8: <>65 28<030B8 2V4 CG0A=8:V2 ?V4B25@465==O B>3>, I> ?@>?>=>20=V =8<8 B>20@8, ?>A;C38 G8 @>1>B8 70 A2>W<8 5:>;>3VG=8<8 G8 V=H8<8 E0@0:B5@8AB8:0<8 2V4?>2V40NBL 28<>30<, CAB0=>2;5=8< C B5=45@=V9 4>:C<5=B0FVW. # @07V 2AB0=>2;5==O 5:>;>3VG=8E G8 V=H8E E0@0:B5@8AB8: B>20@C, @>1>B8 G8 ?>A;C38 70<>2=8: ?>28=5= 2 B5=45@=V9 4>:C<5=B0FVW 707=0G8B8, O:V <0@:C20==O, ?@>B>:>;8 28?@>1C20=L 01> A5@B8DV:0B8 <>6CBL ?V4B25@48B8 2V4?>2V4=VABL ?@54<5B0 70:C?V2;V B0:8< E0@0:B5@8AB8:0<.8=D>@<0FVO ?@> AC1?V4@O4=8:0/ A?V228:>=02FO (C 28?04:C 70:C?V2;V @>1VB G8 ?>A;C3)@8 70:C?V2;V 0<>2=8:>< @>1VB 01> ?>A;C3 #G0A=8: C B5=45@=V9 ?@>?>78FVW 707=0G0T V=D>@<0FVN (?>2=5 =09<5=C20==O B0 <VAF57=0E>465==O) I>4> :>6=>3> AC1 T:B0 3>A?>40@N20==O, O:>3> CG0A=8: ?;0=CT 70;CG0B8 4> 28:>=0==O @>1VB G8 ?>A;C3 O: AC1?V4@O4=8:0/A?V228:>=02FO 2 >1AO7V =5 <5=H5 20 2V4A>B:V2 2V4 20@B>ABV 4>3>2>@C ?@> 70:C?V2;N.9=5A5==O 7<V= 01> 2V4:;8:0==O B5=45@=>W ?@>?>78FVW CG0A=8:><#G0A=8: ?@>F54C@8 70:C?V2;V <0T ?@02> 2=5AB8 7<V=8 4> A2>TW B5=45@=>W ?@>?>78FVW 01> 2V4:;8:0B8 WW 4> 70:V=G5==O :V=F52>3> AB@>:C WW ?>40==O 157 2B@0B8 A2>3> 70157?5G5==O B5=45@=>W ?@>?>78FVW. 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NIH C D;.) - 1 D;. 2 ml (<;). 2. >=B@>;L=0 ?;07<0 (=>@<0;L=0 ;V>DV;L=> 28ACH5=0) =0 1 ml (<;) - 1 D;. =0;VB8G=V E0@0:B5@8AB8:8 "@><1V=>289 G0A 2 :>=B@>;L=V9 ?;07<V 7 0B5AB>20=8< 7=0G5==O< 2 =>@<0;L=V9 >1;0ABV, s (A) 14-18 >5DVFVT=B 20@V0FVW @57C;LB0BV2 287=0G5==O B@><1V=>2>3> G0AC =5 ?5@528ICT 10%. >?CAB8<89 @>7:84 @57C;LB0BV2 287=0G5==O B@><1V=>2>3> G0AC 2 >4=V9 ?@>1V ?;07<8 @V7=8<8 =01>@0<8 >4=VTW A5@VW =5 ?5@528ICT 10%. ?0:>226$V1@8=>35=-B5AB 7 @V4:8< @5035=B>< (100 287=)55997-$V1@8=>35= (G8==8: I) IVD (4V03=>AB8:0 in vitro ), =01V@, 0=0;V7 CB2>@5==O 73CAB:C33696500-0 01>@0B>@=V @50:B828@87=0G5=89 4;O H284:>3> :V;L:VA=>3> 287=0G5==O 7<VABC DV1@8=>35=C 2 ?;07<V :@>2V(E@>=><5B@8G=89 <5B>4 ?> Clauss) =0 :>03C;><5B@V. !:;04 =01>@C 1. "@><1V= (100 >4. NIH/ml (<;)), 10 ml (<;) - 1 D;. 2. CD5@, 4 D;. ?> 10 ml (<;) - 4 D;. 3. 0;V1@0B>@, =0 1 ml (<;) - 1 D;. =0;VB8G=V E0@0:B5@8AB8:8 V=V9=VABL 287=0G5==O: 1.53  7.67 g/l (3/;). >5DVFVT=B 20@V0FVW @57C;LB0BV2 287=0G5==O :>=F5=B@0FVW DV1@8=>35=C =5 ?5@528ICT 10%. >?CAB8<89 @>7:84 @57C;LB0BV2 287=0G5==O :>=F5=B@0FVW DV1@8=>35=C 2 >4=V9 ?@>1V ?;07<8 @V7=8<8 =01>@0<8 >4=VTW A5@VW =5 ?5@528ICT 10%. ?0:>2207!- - ;0B5:A-B5AB63271 - 5B0-35<>;VB8G=0 G8A;5==0 3@C?0 AB@5?B>:>:V2 AB@5?B>;V78= O, 0=B8BV;0 IVD (4V03=>AB8:0 in vitro ), =01V@, 03;NB8=0FVO33696500-0 01>@0B>@=V @50:B828V03=>AB8:C<C 4;O 28O2;5==O 0=B8AB@5?B>;V78=C- 2 A8@>20BFV :@>2V ;N48=8 <5B>4>< ;0B5:A=>W 03;NB8=0FVW !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO, 2 ml (<;) (1 HB.) 2. 5035=B 2. >7G8==8:, 14 ml (<;) (1 HB.) 3. 5035=B 3. >78B82=89 :>=B@>;L, O:89 <VAB8BL ! 1V;LH 200 IU/ml (4/(<;), 0.2 ml (<;) (1 HB.) 4. 5035=B 4. 530B82=89 :>=B@>;L, O:89 <VAB8BL ! <5=H 200 IU/ml (4/<;), 0.2 ml (<;) (1 HB.) 5. 0;8G:8 4;O ?5@5<VHC20==O (100 HB.) 6. "5AB>289 A;094 (2 HB.) =0;VB8G=V E0@0:B5@8AB8:8 'CB;82VABL B5ABC AB0=>28BL 200 IU/ml (4/<;) (03;NB8=0FVO =0 2+). !B0=40@B870FVO 28:>=0=0 ?> <V6=0@>4=><C AB0=40@BC NIBSC ASO.?0:>248 $ - ;0B5:A-B5AB55112 - 52<0B>W4=89 G8==8: IVD (4V03=>AB8:0 in vitro ), =01V@, @50:FVO 03;NB8=0FVW33696500-0 01>@0B>@=V @50:B828V03=>AB8:C< 4;O 28O2;5==O @52<0B>W4=>3> D0:B>@C 2 A8@>20BFV :@>2V ;N48=8 <5B>4>< ;0B5:A=>W 03;NB8=0FVW. !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO, 2 ml (<;) (1 HB.) 2. 5035=B 2. >7G8==8:, 14 ml (<;) (1 HB.) 3. 5035=B 3. >78B82=89 :>=B@>;L, O:89 <VAB8BL $ 1V;LH 12 IU/ml (4/<;), 0.2 ml (<;) (1 HB.) 4. 5035=B 4. 530B82=89 :>=B@>;L, O:89 <VAB8BL $ <5=H 12 IU/ml (4/<;), 0.2 ml (<;) (1 HB.) 5. 0;8G:8 4;O ?5@5<VHC20==O (100 HB.) 6. "5AB>289 A;094 (2 HB.) =0;VB8G=V E0@0:B5@8AB8:8 'CB;82VABL B5ABC AB0=>28BL 12 IU/ml (4/<;) (03;NB8=0FVO =0 2+). !B0=40@B870FVO 28:>=0=0 ?> <V6=0@>4=><C AB0=40@BC $ NIBSC 64/002.?0:>259!  - ;0B5:A-B5AB63234 - C-@50:B82=89 1V;>: (CRP) IVD (4V03=>AB8:0 in vitro ), =01V@, 03;NB8=0FVO, 5:A?@5A-0=0;V733696500-0 01>@0B>@=V @50:B828V03=>AB8:C< 4;O 28O2;5==O !-@50:B82=>3> 1V;:C 2 A8@>20BFV :@>2V ;N48=8 <5B>4>< ;0B5:A=>W 03;NB8=0FVW !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO, 2 ml (<;) (1 HB.) 2. 5035=B 2. >7G8==8:, 14 ml (<;) (1 HB.) 3. 5035=B 3. >78B82=89 :>=B@>;L, O:89 <VAB8BL !  1V;LH 6 mg/l (<3/;), 0.2 ml (<;) (1 HB.) 4. 5035=B 4. 530B82=89 :>=B@>;L, O:89 <VAB8BL !  <5=H 6 mg/l (<3/;), 0.2 ml (<;) (1 HB.) 5. 0;8G:8 4;O ?5@5<VHC20==O (100 HB.) 6. "5AB>289 A;094 (2 HB.) =0;VB8G=V E0@0:B5@8AB8:8 'CB;82VABL B5ABC AB0=>28BL 6 mg/l (<3/;) (03;NB8=0FVO =0 2+). !B0=40@B870FVO 28:>=0=0 ?> @5D5@5=A=><C <0B5@V0;C ERM-DA 474/IFCC.?0:>2410>=>:;>=0;L=89 @5035=B 0=B8-A 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N 0 (1E10 <;)52532-=B8-A 3@C?>25 B8?C20==O 5@8B@>F8BV2 IVD (4V03=>AB8:0 in vitro ), 0=B8BV;0. 33696100-6 50:B828 4;O 287=0G0==O 3@C?8 :@>2V@87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 H;OE>< 28O2;5==O 0=B835=C  5@8B@>F8BV2 ;N48=8 70 4>?><>3>N @50:FVW ?@O<>W 35<03;NB8=0FVW. =0;VB8G=V E0@0:B5@8AB8:8 5035=B8 AB@>3> A?5F8DVG=V. 1. VAB8BL <>=>:;>=0;L=V 0=B8BV;0 0=B8- :;0AC Ig M 2 B8B@V e" 1:32, =5 ?>28=5= 4020B8 03;NB8=0FVW 7 5@8B@>F8B0<8 3@C? (III) V 0(I). 8O2;OT 1 V 2 0=B835=8 5@8B@>F8BV2. 3;NB8=0FVO 5@8B@>F8BV2 7 1V;LH A;01:8<8 20@V0=B0<8 0=B835=C  =0AB0T ?V7=VH5, =V6 7 5@8B@>F8B0<8 1 V 2. 2. 5<03;NB8=CNG0 0:B82=VABL =0 ?;>I8=V <>=>:;>=0;L=>3> @5035=BC 0=B8- - =5 ?V7=VH5 10 s (A). 3. V4B2>@N20=VABL @57C;LB0BV2 A:;040T 100%. D;0:1011>=>:;>=0;L=89 @5035=B 0=B8-B 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N 0 (1E10 <;)52538-=B8-B 3@C?>25 B8?C20==O 5@8B@>F8BV2 IVD (4V03=>AB8:0 in vitro ), 0=B8BV;0. 33696100-6 50:B828 4;O 287=0G0==O 3@C?8 :@>2V@87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N 0 ?@87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 H;OE>< 28O2;5==O 0=B835=C  5@8B@>F8BV2 ;N48=8 70 4>?><>3>N @50:FVW ?@O<>W 35<03;NB8=0FVW =0;VB8G=V E0@0:B5@8AB8:8 5035=B8 AB@>3> A?5F8DVG=V. 1. VAB8BL <>=>:;>=0;L=V 0=B8BV;0 0=B8- :;0AC Ig M 2 B8B@V e" 1:32, =5 ?>28=5= 4020B8 03;NB8=0FVW 7 5@8B@>F8B0<8 3@C? (II) V 0(I). 2. 5<03;NB8=CNG0 0:B82=VABL =0 ?;>I8=V <>=>:;>=0;L=>3> @5035=BC 0=B8- - =5 ?V7=VH5 10 s (A). 3. V4B2>@N20=VABL @57C;LB0BV2 A:;040T 100%. D;0:1012>=>:;>=0;L=89 @5035=B 0=B8-D !C?5@ 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N Rhesus (1E10 <;)52647-=B8-Rh(D) 3@C?>25 B8?C20==O 5@8B@>F8BV2 IVD, (4V03=>AB8:0 in vitro ), 0=B8BV;033696100-6 50:B828 4;O 287=0G0==O 3@C?8 :@>2V@87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N Rhesus 70AB>A>2CTBLAO 4;O 2AB0=>2;5==O @57CA =0;56=>ABV C >AV1 1C4L-O:>W 3@C?>2>W ?@8=0;56=>ABV 70 A8AB5<>N 0. =0;VB8G=V E0@0:B5@8AB8:8 5035=B AB@>3> A?5F8DVG5=. 1.VAB8BL <>=>:;>=0;L=V 0=B8BV;0 0=B8-D :;0AC Ig  2 B8B@V e" 1:32 2. 5<03;NB8=CNG0 0:B82=VABL =0 ?;>I8=V - =5 ?V7=VH5 60 s (A) 0T 28A>:C 35<03;NB8=CNGC 0:B82=VABL V =04V9=> 28O2;OT 2V4?>2V4=89 0=B835= =0 5@8B@>F8B0E O: 3><>-, B0: V 35B5@>783>B=8E D5=>B8?V2 (2 ?@O<V9 @50:FVW =0 ?;>I8=V). !?5F8DVG5= V =5 40T ?5@5E@5A=8E @50:FV9 7 =52V4?>2V4=8<8 0=B835=0<8. V4B2>@N20=VABL @57C;LB0BV2 A:;040T 100%. D;0:8130;V7>- !? 5054758-0;V7> IVD (4V03=>AB8:0 in vitro ), =01V@, A?5:B@>D>B><5B@8G=89 0=0;V733696500-0 01>@0B>@=V @50:B82801i@ @5035=BV2 4;O 287=0G5==O :V;L:>ABV 70;V70 B0 7030;L=>W 70;V7>72'O7CNG>W 740B=>ABV 2 A8@>20BFi B0 ?;07<i :@>2V !:;04 =01>@C 1. 5035=B 1. CD5@: 0F5B0B @ 4.9 - 100 mmol/l (<<>;L/;). 2. 5035=B 2. V4=>2=8:: 0A:>@1V=>20 :8A;>B0 - 99.7%. 3. 5035=B 3. $5@>78=  40 mmol/l (<<>;L/;). 4. !B0=40@B. >4=89 @>7G8= 70;V70  18 mol/l (<:<>;L/;). 5. 5035=B 4. 0A8GCNG89 @>7G8=. >7G8= 70;V70  5 mg/l (<3/;). 6. 5035=B 5. A046C20G  :0@1>=0B <03=VN. 7. >6:0. =0;VB8G=V E0@0:B5@8AB8:8 1. V=V9=VABL 28<V@N20;L=>3> 4V0?07>=C: 0.4 - 180 mol/l (<:<>;L/;). V4E8;5==O 2V4 ;V=V9=>ABV =5 ?5@528ICT 5 %. 2. 'CB;82VABL =5 <5=H 0.4 mol/l (<:<>;L/;). 3. >5DVFVT=B 20@V0FVW @57C;LB0BV2 287=0G5=L  =5 1V;LH 5 %.?0:>2214!5G>20 :8A;>B0 !? 10053583 -!5G>20 :8A;>B0 IVD (4V03=>AB8:0 in vitro ), =01V@, D5@<5=B=89 A?5:B@>D>B><5B@8G=89 0=0;V733696500-0 01>@0B>@=V @50:B82801i@ @5035=BV2 4;O 287=0G5==O :V;L:>ABV A5G>2>W :8A;>B8 2 A8@>20BFV, ?;07<V :@>2V B0 A5GV !:;04 =01>@C 1. 5035=B 1. CD5@: D>AD0B @ 7.4 - 50 mmol/l (<<>;L/;); %$! - 4 mmol/l (<<>;L/;). 2. 5035=B 2. =78<8: C@V:070 - 60 U/l (4/;); ?5@>:A84070 - 660 U/l (4/;); 0A:>@10B >:A84070 - 200 U/l (4/;); 4-0<V=>D5=07>= - 1 mmol/l (<<>;L/;). 3. !B0=40@B. >4=89 @>7G8= A5G>2>W :8A;>B8 - 357 mol/l (<:<>;L/;). =0;VB8G=V E0@0:B5@8AB8:8 1. V=V9=VABL 28<V@N20;L=>3> 4V0?07>=C: 12 - 1200 mol/l (<:<>;L/;). V4E8;5==O 2V4 ;V=V9=>ABV =5 ?5@528ICT 5%. 2. 'CB;82VABL =5 <5=H 12 mol/l (<:<>;L/;). 3. >5DVFVT=B 20@V0FVW @57C;LB0BV2 287=0G5=L  =5 1V;LH 5%.?0:>2315;V:>78;L>20=89 35<>3;>1V= !? 10059090-;V:>78;L>20=89 35<>3;>1V= (HbA1c) IVD (4V03=>AB8:0 in vitro ), =01V@, =5D5;><5B@8G=89/ BC@1V48<5B@8G=8< 0=0;V733696500-0 01>@0B>@=V @50:B82801V@ @5035=BV2 4;O 287=0G5==O :V;L:>ABV 3;V:>78;L>20=>3> 35<>3;>1V=C 2 25=>7=V9 :@>2V (<5B>4>< ;0B5:A=>W BC@1V48<5B@VW). !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO 13%. CD5@, AB01V;V70B>@. 2. 5035=B 2. 8H0GV 0=B8;N4AL:V <>=>:;>=0;L=V 0=B8BV;0  0.05 mg/ml (<3/<;). >;V:;>=0;L=V :>7OGV 0=B8BV;0 4> IgG <8HV  0.8 mg/l (<3/;). 3. 5035=B 3. 5<>;VB8G=89 @5035=B =0;VB8G=V E0@0:B5@8AB8:8 1. V=V9=VABL 28<V@N20;L=>3> 4V0?07>=C: 2-15%. V4E8;5==O 2V4 ;V=V9=>ABV =5 ?5@528ICT 5%. 2. 'CB;82VABL =5 <5=H 2%. 3. >5DVFVT=B 20@V0FVW @57C;LB0BV2 287=0G5=L  =5 1V;LH 5%.?0:>2616!? 0;V1@0B>@ HbA1c. V25=L 153315-;V:>20=89 35<>3;>1V= (HbA1c) IVD (4V03=>AB8:0 in vitro ), :0;V1@0B>@33696500-0 01>@0B>@=V @50:B828V>DV;V7>20=89 35<>;V70B V7 5@8B@>F8BV2 ;N48=8. V25=L 1 @87=0G5=89 4;O :0;V1@C20==O ?@8 287=0G5==V 35<>3;>1V=C 1A. !:;04: N4AL:0 :@>2. >=A5@2>20=0. V>DV;V7>20=0.D;0:217!? 0;V1@0B>@ HbA1c. V25=L 253315-;V:>20=89 35<>3;>1V= (HbA1c) IVD (4V03=>AB8:0 in vitro ), :0;V1@0B>@33696500-0 01>@0B>@=V @50:B828V>DV;V7>20=89 35<>;V70B V7 5@8B@>F8BV2 ;N48=8. V25=L 2 @87=0G5=89 4;O :0;V1@C20==O ?@8 287=0G5==V 35<>3;>1V=C 1A. !:;04: N4AL:0 :@>2. >=A5@2>20=0. V>DV;V7>20=0.D;0:218!? 0;V1@0B>@ HbA1c. V25=L 353315-;V:>20=89 35<>3;>1V= (HbA1c) IVD (4V03=>AB8:0 in vitro ), :0;V1@0B>@33696500-0 01>@0B>@=V @50:B828V>DV;V7>20=89 35<>;V70B V7 5@8B@>F8BV2 ;N48=8. V25=L 3@87=0G5=89 4;O :0;V1@C20==O ?@8 287=0G5==V 35<>3;>1V=C 1A. !:;04: N4AL:0 :@>2. >=A5@2>20=0. V>DV;V7>20=0.D;0:219!? 0;V1@0B>@ HbA1c. V25=L 453315-;V:>20=89 35<>3;>1V= (HbA1c) IVD (4V03=>AB8:0 in vitro ), :0;V1@0B>@33696500-0 01>@0B>@=V @50:B828V>DV;V7>20=89 35<>;V70B V7 5@8B@>F8BV2 ;N48=8. V25=L 4. @87=0G5=89 4;O :0;V1@C20==O ?@8 287=0G5==V 35<>3;>1V=C 1A. !:;04: N4AL:0 :@>2. >=A5@2>20=0. V>DV;V7>20=0.D;0:220!? >=B@>;L HbA1c. V25=L 144435->=B@>;L=89 <0B5@V0; 4;O 287=0G5==O 3;V:>20=>3> 35<>3;>1V=C (HbA1c), IVD (4V03=>AB8:0 in vitro )33696500-0 01>@0B>@=V @50:B828V>DV;V7>20=89 35<>;V70B 7 5@8B@>F8BV2 ;N48=8. V25=L 1 @87=0G5=89 4;O :>=B@>;N O:>ABV 4>A;V465=L ?@8 287=0G5==V 35<>3;>1V=C 1A. !:;04: N4AL:0 :@>2. >=A5@2>20=0. V>DV;V7>20=0.D;0:221!? >=B@>;L HbA1c. V25=L 244435->=B@>;L=89 <0B5@V0; 4;O 287=0G5==O 3;V:>20=>3> 35<>3;>1V=C (HbA1c), IVD (4V03=>AB8:0 in vitro )33696500-0 01>@0B>@=V @50:B828V>DV;V7>20=89 35<>;V70B 7 5@8B@>F8BV2 ;N48=8. V25=L 2 @87=0G5=89 4;O :>=B@>;N O:>ABV 4>A;V465=L ?@8 287=0G5==V 35<>3;>1V=C 1A. !:;04: N4AL:0 :@>2. >=A5@2>20=0. V>DV;V7>20=0.D;0:222! -BC@1V !? 10053705-C-@50:B82=89 1V;>: (! ) IVD (4V03=>AB8:0 in vitro ), =01V@,=5D5;><5B@8G=89/BC@1V48<5B@8G=89 0=0;V733696500-0 01>@0B>@=V @50:B82801V@ @5035=BV2 4;O 287=0G5==O :V;L:>ABV !-@50:B82=>3> 1V;:C 2 A8@>20BFV :@>2V (<5B>4>< ;0B5:A=>W BC@1V48<5B@VW). !:;04 =01>@C 1. 5035=B 1. >7G8==8:: B@VA-1CD5@ @ 8.2 - 20 mmol/l (<<>;L/;). 2. 5035=B 2. 0B5:A=0 ACA?5=7VO. =0;VB8G=V E0@0:B5@8AB8:8 1. V=V9=VABL 28<V@N20;L=>3> 4V0?07>=C: 2-150 mg/l (<3/;). V4E8;5==O 2V4 ;V=V9=>ABV =5 ?5@528ICT 8%. 2. 'CB;82VABL =5 <5=H 2 mg/l (<3/;). 3. >5DVFVT=B 20@V0FVW @57C;LB0BV2 287=0G5=L  =5 1V;LH 8%.?0:>28235B5@35=B !? 250 <;63377- 0AV1 4;O >G8I5==O ?@8;04C/ 0=0;V70B>@0 IVD (4V03=>AB8:0 in vitro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