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͸ײIgGwzyԇУø“(lin)߷_ϺsʢˎI(y)ɷ޹˾
ԇ
\ \

͸ײIgGwzyԇУø“(lin)߷

͸ײIgGwzyԇУø“(lin)߷

a(chn)ƷQ

ͨQ͸ײIgGwzyԇУø“(lin)߷

bҎ(gu)

48 ˷/У96 ˷/

A(y); 

a(chn)ƷwⶨԙzyѪ͸ײIgGw

Y(ji)HRR\εΨһ(j)͸ײȾo\ࡣ

ϢB

͸ײHEVСs2734nmĆι期oĤRNAMȫLs7.5kb3_xaܣORFORF1ac(f)P(gun)ĹԵORF2cORF3ƜyaĽY(ji)(gu)ORF2 C˾aҪY(ji)(gu)ҪĿԭλcо߂ͨ^ϳĿԭؽMԭоl(f)F(xin)˶ԭλоORF2ؽMԭcϳĿԭELISAzyHEVwR\

͸(Q) ͸ײHepatitis E Virus, HEVȾR͸׵IJʸڼ͸׺͸ףҪڰl(f)չЇ,ȾHEVɸ_(d)20%,3µDŮ߿_(d)56%YоһN󹲻Ⱦ͸DZo(j)80ĩl(f)F(xin)µIJԸ֮һȫУVҊځc޵؅^(q)҇DzԸ׸߰l(f)^(q)(j)y(tng)ӋڼԲԸ͸װl(f)ʞ3.420.5ƽ8.6

GENELABS®͸ײIgMIgG ELISAzyԇΨһ@ÇˎƷM(jn)עC͸ײzyM(jn)ԇ GENELABSHEV IgMIgGԇвø“(lin)͸ײMضйԵĻƬ΁քezywѪѪ{пHEV IgMIgG@N(bio)־ؽMƬγɹؑ(yng)ڲͬĵطЅ^(q)ļ͸׸Ⱦ\ѪW(xu)HEV IgMIgGzy\͸ײȾҪָ(bio)֮һ

ƷɻؽM_(d)͸ײHEVԭ΢װӴyѪ, (dng)yƷд͸ײwtγɿԭwخY(ji)ټ뿹IgGøY(ji)c䷴(yng)(jng)ø@ɫø(bio)xϜy(j)ODֵжПo͸ײ IgGwĴ

ҪMɳ

1͸ײԭ΢װ

96ס1K

48ס1K

2øY(ji)

10mL1ƿ

5mL1ƿ

3Ԍ

1mL1ƿ

1mL1ƿ

4Ԍ

1mL1ƿ   

1mL1ƿ   

5ϴҺǰ120ϡጣ

50mL1ƿ

50mL1ƿ

6A

6mL1ƿ

3mL1ƿ

7

6mL1ƿ

3mL1ƿ

8KֹҺ

6mL1ƿ

3mL1ƿ

9ƷϡҺ

10mL1ƿ

5mL1ƿ

(10)

3

3

MݽMɣ1͸ײԭ΢װ壺ûؽM_(d)͸ײ14͵ORF2ORF3λԭϰϩ΢װ2øY(ji)50%СţѪ壬15%ɽѪ0.1%0.01M}_Һ(pH7.4)3Ԍգ͸ײIgGwzyѪ4Ԍգ͸ײIgGwzyѪ5ϴҺ}_Һ-0.5œ206A8.00g ,^0.70g; 7B2.10gҶ0.38g3,3',5,5'-ļ׻“(lin) 0.40g8KֹҺ2M  H2SO49ƷϡҺ0.24%u׻飨Tris_Һ1.78%NaCl0.5%ҵc0.2%ţѪ׵0.1%œ-200.1%ͨX-1005%ɽѪ0.1%

 

ԇБ(yng)2~8бܹⱣ棬Ч12δİ΢װl(yng)Էܷcʣԇ2~8汣һ܃(ni)ꡣ\ݔ5첻Ӱ䷀(wn)

a(chn)ڼЧҊ(bio)

mÃx

ø(bio)xz򞲨L450nmL630nm

ӱҪ  

1ӱɼҪ(zhn)䣬IJѪg(sh)ռѪҺȫѪƷȷ37̎2СrٌѪƷxģ3000D(zhun)/x6ʹѪ岻OٺѪ(x)鿹ѪƷ(yng)ѪƷxĺٷҜ2Сr

2ӱʹѪػEDTAȿӰ푌Y(ji)

3ӱкïBcӰ푌Y(ji)߶ѪĘӱ]ȫտsѪӱ΢ȾĘӱܕe`ĽY(ji)

4rĘӱ2~8±һڣrӱLڃ-20ⷴ(f)ڡ

z򞷽 

1(zhn)䣺حh(hun)ȡԇУҜƽ30ͬrsϴҺ1:20ϡ

2ӴyӱÿΌO(sh)ԌԌոɿքeԌѪ100LO(sh)һ׿հ׌ӘƷϡҺ100L׼100LƷϡҺټӴyѪ10Lֻ3730ȥ׃(ni)ӱ۸ɡ

3ϴ壺1ֹϴ壺ȥ΢װl׃(ni)ҺwˮĸɣϴҺעMÿo5~10ȥ׃(ni)ϴҺĸ˷(f)5ĸ

2ϴCϴ壺xϴ5εijϴϴҺ(yng)עMÿ_ÿoˮĸɡ

4øY(ji)ÿ׼100Lհ׌տײֻNճ3720

5ϴ壺ͬ3

6@ɫȼ@ɫAҺ50L ټ@ɫBҺ50Lֻ37 ܹ10

7Kֹ(yng)ÿ׼ӽKֹҺ50L

8yø(bio)xx(sh)xÆβL450nm(Կհ׿У)450/630nmxȡODֵx(sh)ڽKֹ10犃(ni)ɡ

Дֵ

Cutoff ֵӋ㣺COV=ԌƽODֵ0.12 

(bio)ODֵCOV(bio)ODֵ

עԌODֵ0.050.05Ӌ㣬0.05HODֵӋ

zY(ji)Ľ

1ԽY(ji)ӱв͸ײIgGwӱе͸ײIgGwԇеęzy

2ԽY(ji)ӱк͸ײIgGwخ(yng)ء

3ԽY(ji)ĘӱҪM(jn)؏(f)򞣬ֻн(jng)^؏(f)؏(f)ԞԽY(ji)ĘӱJ(rn)͸ײIgGw؏(f)Y(ji)ԵĘӱ(yng)(jng)^m(dng)?sh)ֶM(jn)д_J(rn)

ԽY(ji)Ęӱ(f)zԽY(ji)(yng)J(rn)Ԙӱ؏(f)F(xin)ԽY(ji)܌һg(sh)}£

1 ڃxӘɵĽȾ

2 @ɫxȾ

3 ԇ©ɵĽȾ

4 ֵϴȥصס

4ԇڼԡ԰l(f)Ŀ93.8%خ94.4%

ԇ򞷽ľ 

ƷHڙzyѪ͸ײIgGwwzyRo\

a(chn)Ʒָ(bio)

1.ԇ^͸Һwo

2.10͸ײwIgGԅƷzy(yng)ȫz

3.10͸ײwIgGԅƷzy(yng)ȫz

4.4͸ײwIgG`ȅƷzyS1S2S3 (yng)ԣS4

5.1͸ײwIgGԅƷzyCV%(yng)15n=10

6.(wn)Ԍ򞣺ԇM376zY(ji)(yng)_(d)(bio)(zhn)

7.bݘ(bio)ʾb

8.֬ѪSȸɔ_ӌzyY(ji)Ӱ푣Ȟ2.1mmol/L(ֵ0.22~1.65mmol/L)ѪtםȞ210g/L(ֵ110~170g/L), đ̴Ȟ8.5 mmol/L(ֵ:2.6~6.5mmol/L)Ӱ푱ƷzyY(ji)

9.cԭwĽ淴(yng)о:HAV16HBV23HCV24HIV26TORCH 18M(jn)н淴(yng)ԇY(ji)Ӱ푱ƷęzyY(ji)

10.RоϢ飺оԇc(zhn)͸ײIgGwzyԇR(bio)M(jn)Ќșzy^خԵȷĵЧ

ĿӱĴ_(j)(j)w\ԇעԹkҎ(gu)оa(chn)Ʒa(chn)Ʒ(j)w\ԇRоg(sh)ָ(do)ԭtRоӱ(sh)1314оY(ji)93.8%;خ94.4%;ӱ94.1%

ע

1 ƷHw\࣬HڙzywѪzyY(ji)HRR\εΨһ(j)

2 2~8lȡĘӱ(yng)Ҝƽ30M(jn)Йzy

3 횴_ƷӘĜ(zhn)_ӘӲ(zhn)_ܕ(do)e`ČY(ji)

4 ʹ΢ҺֹӘӕrÿΑ(yng)ԓQ^ȡӱ

õƿμӕrՈƿҺwu򣬲ȥ1~2κֱٵصμҪ⌢MеҺw|R΢װ߅ϣ؄eøY(ji)

6 ڲ^Б(yng)Mⷴ(yng)΢Юa(chn)

7 sϴҺϵߝ}ܕγɽY(ji)δȫܽӰ푌Y(ji)ͬrܕסԄӼӘϴCܵF(xin)Y(ji)Ո37ܽȻϡጻʹ

8 z؏(f)ʹ

9 ˮԡ偷(yng)rՈ(yng)ˮ1/3ײԾW(wng)֧֧ˮؿ37

10ϴ壺1ϴCϴrϴCļҺP(gun)ҪȱϴҺ^ܳM(yng)΢ϴΔ(sh)(yng)ԓ5(jng)עzҺ^Ƿ

2ֹϴrՈʹÎмˮİԷԴ^ø߀ԭ|(zh)c@ɫl(f)(yng)Ӱ푙zyY(ji)Ĝ(zhn)_

3ϴrõˮՈ𷴏(f)ʹá

4ϴCÿʹǰsˮȥxˮϴɃԷֹܵg

11ʹȫԄø(bio)ϵy(tng)ܕϵy(tng)`(yng)ϵy(tng)(sh)O(sh)m(dng){(dio)ԝMP(gun)|(zh)ƷҪ

12κԇ|Ƥw۾ôˮԓλM(jn)ДU(ku)ϴKֹҺиgԡ

13ԇЃ(ni)P(gun)MݼRӱҕНڂȾՈP(gun)ČҹҎ(gu)(zh)к̎

īI(xin)

1.R҅Ķxʹ_

2. 2006|ϴW(xu)ġȫRzҎ(gu)̡

3.RW(xu)w\ԇУͨüg(sh)Ҫ

t(y)еa(chn)I(y)SC̖

t(y)еעC̖/a(chn)Ʒg(sh)Ҫ̖ 

f˜(zhn)ڼ޸ڡ