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͸ײ濹ԭ\ԇУø“(lin)߷_ϺsʢˎI(y)ɷ޹˾
ԇ
\ \

͸ײ濹ԭ\ԇУø“(lin)߷

͸ײ濹ԭ\ԇУø“(lin)߷

ˎƷQ(chng)

ͨQ(chng)͸ײ濹ԭ\ԇУø“(lin)߷

ӢQ(chng)Diagnostic Kit for Hepatitis B Virus Surface Antigen (ELISA) 

hZ(y)ƴYixing Ganyan Bingdu Biaomian Kangyuan Zhenduan Shijihe (Meilianmianyifa)


bҎ(gu)

48˷/С96˷/576˷/


A(y);

͸ײ濹ԭ\ԇmڶԜy(c)ѪѪ{͸ײ濹ԭѪҺY鼰R͸ײȾo\


z(yn)ԭ

         ͸ײ濹ԭ\ԇвpwAķzy(c)HBsAgÿ-HBslHRP(bio)ӛĿ-HBsø(bio)ӛļ׻“(lin)TMB^(gu)(dng)(bio)дHBsAgr(sh)ԓHBsAgc-HBsY(ji)ϲc-HBs-HRPY(ji)γɿ-HBs-HBsAg--HBs-HRP(f)TMBa(chn)@ɫ(yng)֮to(w)@ɫ(yng)ڌ(sh)(yn)Y(ji)r(sh)ɫ׃ʾHBsAgڣo(w)ɫɫ׃΢tʾHBsAg


ҪMɳɷݡ

ԇнMɣ

48˷/

96˷/

576˷/

1.A(y)(yng)

48/K

1K

96/K

1K

96/K

6K

2.øY(ji)

3ml

1ƿ

6ml

1ƿ

40ml

1ƿ

3.(yng)Ԍ(du)

0.8ml

1ƿ

0.8ml

1ƿ

4ml

1ƿ

4.Ԍ(du)

0.8ml

1ƿ

0.8ml

1ƿ

4ml

1ƿ

5.sϴҺ

30ml

1ƿ

30ml

1ƿ

100ml

2ƿ

6.@ɫA

3ml

1ƿ

6ml

1ƿ

40ml

1ƿ

7.@ɫB  

3ml

1ƿ

6ml

1ƿ

40ml

1ƿ

8KֹҺ2MH2SO4

3ml

1ƿ

6ml

1ƿ

40ml

1ƿ

9.z

12Ƭ

10.f(shu)(sh)

1    

1  

1

11.Է

      ע⣺̖ͬ(ho)ԇԇнM12 ɻ


Ʒ̓x

1. rsˮȥxˮ

2. һ

3. _΢Һ͝^

4. Ƀˮ

5. 37ˮԡ

6. Ӌ(j)r(sh)

7. ϴC(j)ϴƿ

8. ʎ

9. ø(bio)x zy(c)L(zhng)450nmL(zhng)630nm


(ch)lЧڡ

  ԇБ(yng)28бܹⱣЧ12(g)¡


ӱҪ

1. ӱɼҪ(zhn)Ҫܙz߽ʳIJѪg(sh)ռѪҺȫѪƷȷ37̎2Сr(sh)ٌѪƷx3000D(zhun)/x6ʹѪ壨{OٺѪ(x)鿹ѪƷ(yng)ѪƷxĺٷҜ2Сr(sh)

2. ӱʹѪѪ{ػEDTAȿ(hu)Ӱ푌(sh)(yn)Y(ji)

3. ӱкïBc(hu)Ӱ푌(sh)(yn)ĽY(ji)߶ѪĘӱ](mi)ȫտsѪӱ΢ȾĘӱܕ(hu)e(cu)`ĽY(ji)

4. rĘӱ28o(w)lɱһrӱL(zhng)A-20£ⷴ(f)


z(yn)

1. (sh)(yn)(zhn)䣺حh(hun)ȡԇҜƽ30ͬr(sh)sϴҺ120ϡ

2. Ӵy(c)(bio)ÿԇ(yn)O(sh)(yng)Ԍ(du)ոɿքeꎡ(yng)Ԍ(du)0.1հ׌(du)1׼y(c)(bio)0.1, 3760犡

3. øY(ji)ÿ0.05հ׌(du)տײֻ3730

4. ϴ壺1ֹϴ壺ȥ(yng)l׃(ni)ҺwˮĸϴҺעM(mn)ÿףo5-10ȥ׃(ni)ϴҺĸ˷(f)5ĸɡ

2ϴC(j)ϴ壺xϴ5εijϴϴҺ(yng)עM(mn)ÿ_ÿo(w)ˮĸ

5.  ȼ@ɫAÿ0.05 ټ@ɫBÿ0.05ֻ򣬷37ܹ30

6. Kֹ(yng) ÿ׼KֹҺ0.05

7. y(c)ø(bio)xx(sh)xβL(zhng)450 nmԿհ׿У㣩pL(zhng)450/630 nmxȡODֵx(sh)ڽKֹ(yng)10犃(ni)


ֵ

1. Ԍ(du)ƽֵС0.1(yng)Ԍ(du)ƽֵ1.2(sh)(yn)Y(ji)Ч

2. Ԍ(du)ODֵ0.050.05Ӌ(j)0.05(sh)HODֵӋ(j)

3. Cutoff ֵӋ(j)㣺 COV = Ԍ(du)ƽODֵ2.1


z(yn)Y(ji)Ľጡ

    1. (bio)ODֵCOV(yng)(bio)ODֵCOV

2. ԽY(ji)ӱвHBsAgӱеHBsAgԇеęzy(c)

3. (yng)ԽY(ji)ӱкHBsAgخ(yng)

4. (yng)ԽY(ji)ĘӱҪM(jn)؏(f)(sh)(yn)ֻн(jng)^(gu)؏(f)؏(f)(sh)(yn)Ԟ(yng)ԽY(ji)ĘӱJ(rn)HBsAg(yng)؏(f)Y(ji)(yng)ԵĘӱ(yng)(jng)^(gu)m(dng)?sh)ֶM(jn)д_J(rn)

(yng)ԽY(ji)Ęӱ(f)zԽY(ji)(yng)J(rn)Ԙӱ؏(f)(yng)ԽY(ji)܌һ(g)(g)g(sh)(wn)}£

1)ڃxӘɵĽȾ

2)@ɫxȾ

3)ԇ©ɵĽȾ

4)ֵϴȥصס


z(yn)ľԡ

     иԵߌ(sh)(yn)ϵy(tng)ڝڵķخԷ(yng)؏(f)(yng)ԽY(ji)(yng)һ(g)m(dng)?sh)ķM(jn)д_J(rn)


a(chn)Ʒָ(bio)

1. ԇ^(gun)ҺwM֑(yng)

2. ԅƷʣÇ(gu)҅ƷM(jn)ЙzóF(xin)(yng)

3. (yng)ԅƷʣÇ(gu)҅ƷM(jn)Йzzy(c)3ݝֵ5104IU/mlHBsAg(yng)ԅƷóF(xin)

4. ͙zÇ(gu)҅ƷM(jn)ЙzHBsAg adradway͵͙zҪ

5. ԣþԅƷy(c)CV%(yng)15%n=10

6. (wn)ԇ(yn)ԇM376zY(ji)_(d)Ϙ(bio)(zhn)

7. bݘ(bio)ʾb


ע(xing)

1. z(yn)ϴ|(zh)P(gun)ҪȱϴҺ^(gu)ܳM(mn)(yng)΢ϴΔ(sh)(yng)5(jng)עzҺ^Ƿ

2. ֹϴr(sh)Ո(qng)ʹÎмˮİ壬ԷԴ^(gu)ø(li)߀ԭ|(zh)c@ɫl(f)(yng)Ӱ푙zy(c)Y(ji)Ĝ(zhn)_ԡ

3. ϴr(sh)õˮՈ(qng)𷴏(f)ʹ

4. ϴC(j)ÿʹǰsˮȥxˮ_ϴɃԷֹ·g

5. κԇ|Ƥw۾ôˮ(du)ԓλM(jn)ДU(ku)ϴKֹҺиg

6. ԇЃ(ni)P(gun)MݼRӱ(yng)ҕНڂȾՈ(qng)P(gun)Č(sh)(yn)ҹҎ(gu)(li)(zh)к̎

7. ʹȫԄ(dng)øϵy(tng)ܕ(hu)ϵy(tng)`(yng)(du)ϵy(tng)(sh)O(sh)m(dng){(dio)ԝM(mn)(gu)P(gun)|(zh)ƷҪ

ˎƷa(chn)SC̖(ho):20160052

a(chn)Ʒ(zhn)̖(ho)(gu)ˎ(zhn)S10950045

a(chn)Ʒ(bio)(zhn)̖(ho)YBS00412010

f(shu)(sh)(zhn)޸ڡ