ʻO COVID-19 IgG/IgM ka pahu hoʻāʻo wikiwiki

No ka hoʻohana ʻana i ka diagnostics ʻoihana a in vitro wale nō.

KA MANAO ANA

ʻO kaʻO COVID-19 IgG/IgM ka pahu hoʻāʻo wikiwikihe immunoassay kahe lateral i hoʻolālā ʻia no ka ʻike qualitative o IgG a me IgM antibodies i ka maʻi SARS-CoV-2 i loko o ke koko holoʻokoʻa, serum a i ʻole plasma specimens mai nā poʻe i manaʻo ʻia he maʻi COVID-19 e kā lākou mea mālama ola.

ʻO ka CO VID-19 IgG/IgM Rapid Test he mea kōkua i ka hōʻoia ʻana o nā mea maʻi me ka maʻi i manaʻo ʻia ʻo SARS -CoV-2 i hui pū ʻia me ka hōʻike lapaʻau a me nā hopena o nā hoʻokolohua ʻē aʻe. Manaʻo ʻia e hoʻohana ma ke ʻano he hōʻailona hōʻike hoʻohui no nā hihia i manaʻo ʻia me ka hoʻāʻo ʻana o ka nucleic acid maikaʻi ʻole o ka coronavirus novel a i hoʻohana pū ʻia me ka hoʻāʻo nucleic acid i nā hihia i manaʻo ʻia. ʻAʻole pono e hoʻohana ʻia nā hopena mai ka hoʻāʻo ʻana i ka antibody ma ke ʻano he kumu hoʻokahi e hōʻoia ai a wehe ʻole i ka maʻi SARS -CoV-2 a i ʻole e hoʻomaopopo i ke kūlana maʻi.

ʻAʻole ʻae nā hopena maikaʻi ʻole i ka maʻi SARS -CoV-2, ʻoi aku ka nui o ka poʻe i launa pū me nā mea maʻi i ʻike ʻia a i nā wahi me ka nui o ka maʻi maʻi. Pono e noʻonoʻo ʻia ka hoʻāʻo ʻana me ka diagnostic molecular e kāpae i ka maʻi i loko o kēia poʻe.

Loaʻa paha nā hopena maikaʻi ma muli o ka maʻi i hala a i kēia manawa paha me nā maʻi coronavirus non-SARS-CoV-2.

Hoʻohana ʻia ka hoʻāʻo ma nā keʻena lapaʻau lapaʻau a i ʻole e nā limahana mālama olakino ma kahi o ka mālama, ʻaʻole no ka hoʻohana ʻana i ka home. ʻAʻole pono e hoʻohana ʻia ka hoʻāʻo no ka nānā ʻana i ke koko i hāʻawi ʻia.

HOOLAHA

Aia nā coronaviruses hou i ka genus p.COVID-19he ma'i lele hanu. Hiki ke maʻalahi nā kānaka. I kēia manawa, ʻo nā maʻi i loaʻa i ka coronavirus novel ke kumu nui o ka maʻi; ʻO ka poʻe i hoʻopaʻa ʻia asymptomatic hiki ke lilo i kumu maʻi. Ma muli o ka noiʻi epidemiological o kēia manawa, ʻo ka manawa incubation he 1 a 14 mau lā, ʻo ka hapa nui he 3 a 7 mau lā. ʻO nā hōʻike nui e pili ana i ke kuni, ka luhi a me ka ʻū maloʻo. Loaʻa ka nasal congestion, runny ihu, ʻeha ʻāʻī, myalgia a me ka maʻi maʻi i kekahi mau hihia.

Ke hoʻopili nei ka maʻi SARS-CoV2 i kahi kino, ʻo RNA, ka mea genetic o ka maʻi, ʻo ia ka māka mua e ʻike ʻia. ʻO ke ʻano o ka viral load profile o SARS-CoV-2 e like me ka influenze, e piʻi ana i ka manawa o ka hoʻomaka ʻana o nā hōʻailona, ​​​​a laila hoʻomaka e emi. Me ka hoʻomohala ʻana o ka papa maʻi ma hope o ka maʻi maʻi, e hoʻopuka ka ʻōnaehana pale kanaka i nā antibodies, ma waena o ka IgM ka antibody mua i hana ʻia e ke kino ma hope o ka maʻi, e hōʻike ana i ka pae koʻikoʻi o ka maʻi. Hiki ke ʻike ʻia nā antibodies IgG i SARS-CoV2 ma hope o ka maʻi. Hiki ke loaʻa nā hopena maikaʻi no ka IgG a me ka IgM ma hope o ka maʻi a hiki ke hōʻike i ka maʻi koʻikoʻi a i ʻole ka maʻi hou. Hōʻike ka IgG i ka manawa hoʻomaha o ka maʻi a i ʻole ka mōʻaukala o ka maʻi i hala.

Eia nō naʻe, loaʻa i ka IgM a me IgG ka manawa puka makani mai ka maʻi maʻi a hiki i ka hana antibody, ʻaneʻane ʻike ʻia ka IgM ma hope o ka hoʻomaka ʻana o ka maʻi i kekahi mau lā, no laila ke waiho pinepine nei ko lākou ʻike ʻana ma hope o ka ʻike ʻana i ka waikawa nucleic a ʻoi aku ka liʻiliʻi ma mua o ka ʻike waika nucleic. I nā hihia i maikaʻi ʻole ai nā hoʻokolohua nucleic acid amplification a aia kahi loulou epidemiological ikaika i ka maʻi COVID-19, hiki i nā laʻana serum paired (i ka manawa acute a convalescent) ke kākoʻo i ka maʻi maʻi.

KUMU

ʻO COVID-19 IgG/IgM ka pahu hoʻāʻo wikiwiki(WB/S/P) kahi immunoassay e pili ana i ka membrane qualitative no ka ʻike ʻana i nā antibodies (IgG a me IgM) i ka Novel coronavirus i loko o ke koko holoʻokoʻa o ke kanaka / Serum / plasma. Aia ka pahu ho'āʻo：1) kahi pad coiyugate kala burgundy i loaʻa i ka Novel coronavirus recombinant envelopp antigens coi^ugated me Colloid gula (Novel coronavirus c两ugates), 2) kahi ʻāpana membrane nitrocellulose i loaʻa nā laina hoʻāʻo ʻelua (laina IgG a me IgM) a me kahi laina mana (laina C). Ua uhi mua ʻia ka laina IgM me ka antibody IgM anti-Human Mouse, ua uhi ʻia ka laina IgG Mouse anti-Human IgG antibody, i ka wā e hāʻawi ʻia ai ka nui o nā mea hoʻohālike i loko o ka luawai laʻana o ka cassette hoʻāʻo. Ke neʻe nei ka specimen ma ka hana capillary ma o ka cassette. ʻO ka IgM anti-Novel coronavirus, inā aia i loko o ka specimen, e hoʻopaʻa i ka Novel coronavirus coiyugates. A laila hopu ʻia ka immunocomplex e ka reagent i uhi mua ʻia ma ka band IgM, e hana ana i kahi laina IgM kala burgundy, e hōʻike ana i kahi hopena hōʻike maikaʻi o ka Novel coronavirus IgM. ʻO ka IgG anti-Novel coronavirus i loaʻa i ka specimen e hoʻopaʻa i nā conjugates Novel coronavirus. A laila hopu ʻia ka immunocomplex e ka reagent i uhi ʻia ma ka laina IgG, e hana ana i kahi laina IgG kala burgundy, e hōʻike ana i kahi hopena hōʻike maikaʻi o ka Novel coronavirus IgG. ʻO ka nele o nā laina T (IgG a me IgM) e hōʻike ana i kahi

hopena maikaʻi ʻole. No ka lawelawe ʻana ma ke ʻano he mana kaʻina hana, e ʻike mau ʻia kahi laina kala ma ka ʻāpana laina mana e hōʻike ana ua hoʻohui ʻia ka nui kūpono o ka specimen a ua hana ʻia ka membrane wicking.

OLELO HOOLAHA A ME KA MALAMA

• No ka hoʻohana diagnostic in vitro wale nō.
• No nā ʻoihana mālama ola kino a me nā ʻoihana wahi o ka mālama.

• Mai hoʻohana ma hope o ka lā pau.

• e ʻoluʻolu e heluhelu i ka ʻike a pau i loko o kēia lau ma mua o ka hana ʻana i ka hoʻāʻo. • Pono ka pahu ho'āʻo i loko o ka ʻeke i hoʻopaʻa ʻia a hiki i ka hoʻohana ʻana.

• Pono e noʻonoʻo ʻia nā mea hoʻohālike a pau he mea pōʻino a mālama ʻia ma ke ʻano like me ka lāʻau lapaʻau.

• Pono e hoʻolei ʻia ka pahu hoʻāʻo i hoʻohana ʻia e like me nā hoʻoponopono federal, mokuʻāina a kūloko.

COMPOSITION

Aia i loko o ka ho'āʻo kekahi ʻāpana membrane i uhi ʻia me ka antibody anti-Human IgM Mouse a me ka antibody IgG anti-Human Mouse ma ka

laina hoʻāʻo, a me kahi pad dye i loaʻa i ke gula colloidal i hui pū ʻia me Novel corona virus recombinant antigen. Ua paʻi ʻia ka nui o nā hoʻokolohua ma ka lepili.

Nā mea i hāʻawi ʻia

• Pīke ho'āʻo • Hoʻokomo pūʻolo
• Hoopaa • Hoopae
• Lancet

Pono nā mea pono akā ʻaʻole i hāʻawi ʻia

• ʻOhi pahu hōʻailona • Timer

HOOLAHA A ME KA PALAPALA

• E kūʻai e like me ka mea i hoʻopaʻa ʻia i loko o ka ʻeke i hoʻopaʻa ʻia ma ka mahana (4-30″Cor 40-86°F).

• I ka wehe ʻana i ka ʻeke, pono e hoʻohana ʻia ka lest i loko o hoʻokahi hola. ʻO ka loaʻa ʻana i ka ʻāina wela a me ka haʻahaʻa e hōʻino ʻia ka huahana.

• Ua paʻi ʻia ka LOT a me ka lā pau ma ka lepili SPECIMEN

• Hiki ke hoʻohana ʻia ka hoʻāʻo ʻana no ka hoʻāʻo ʻana i ke koko holoʻokoʻa / Serum / Plasma specimens.

•E hōʻiliʻili i ke koko holoʻokoʻa, serum a i ʻole plasma specimen ma hope o nā kaʻina hana hoʻokolohua maʻamau.

•E hoʻokaʻawale i ka serum a i ʻole ka plasma mai ke koko i ka hiki ke pale aku i ka hemolysis. E hoʻohana wale i nā mea hoʻohālike akaka ʻole hemolyzed.

• E mālama i nā mea hoʻohālike ma 2-8 °C (36-46T) inā ʻaʻole hoʻāʻo koke ʻia. E mālama i nā mea hoʻohālike ma 2-8 °C a hiki i 7 lā. Pono e hoʻopaʻa ʻia nā mea hoʻohālike ma ka -20 °C (-4°F) no ka mālama lōʻihi. Mai hoʻokuʻu i ke koko holoʻokoʻa、

• Hōʻalo i nā pōʻai hoʻoheheʻe he nui, ma mua o ka hoʻāʻo ʻana, e lawe mālie i nā mea hoʻohālike hau i ka lumi wela a hui mālie.

Pono e hoʻomaʻamaʻa ʻia nā mea kikoʻī i loaʻa i nā mea ʻāpana ʻike ʻia e ka centrifugation ma mua o ka hoʻāʻo ʻana.

• Mai hoʻohana i nā laʻana e hōʻike ana i ka lipemia gross hemolysis nui a i ʻole turbidity i mea e pale aku ai i ka hoʻopilikia ʻana i ka wehewehe ʻana i ka hopena.

HANA HO'O

E ʻae i ka mea hoʻāʻo a me nā mea hoʻohālike e hoʻohālikelike i ka mahana (15-30 C a i ʻole 59-86 T) ma mua o ka hoʻāʻo ʻana.

1. Wehe i ka Cassette hoʻāʻo mai ka ʻeke i hoʻopaʻa ʻia.
2. E hoʻopaʻa i ka mea hoʻoheheʻe a hoʻololi i 1 kulu (ma kahi o 10 ul) o ka mea hoʻohālike i loko o ka ʻāpana o luna o ka pūnāwai specimen (S) me ka ʻike pono ʻaʻole he ʻōhū ea. No ka ʻoi aku ka pololei, e hoʻololi i ka specimen me kahi pipette hiki ke hāʻawi i 10 ul o ka nui. E nānā i ke kiʻi ma lalo.
3. A laila, e hoʻohui i 2 kulu (ma kahi o 70 ul) o ka buffer i loko o ka pūnāwai specimen (S).
4. E hoʻomaka i ka manawa.
5. no ka puka ʻana o nā laina kala. E wehewehe i nā hopena hoʻokolohua ma 15 mau minuke. Mai heluhelu i nā hopena ma hope o 20 mau minuke.

Wahi no ka Laʻana

(No ke kuhikuhi wale nō ke kiʻi, e ʻoluʻolu e nānā i ka mea waiwai.)

KA WAIWAI O NA HUNAHUNA

antibodies. ʻO ka hiʻohiʻona o ka laina hōʻike IgM e hōʻike ana i ka hele ʻana o nā antibodies IgM kikoʻī coronavirus Novel. A inā ʻike ʻia nā laina ʻelua IgG a me IgM, e hōʻike ana i ka hele ʻana o nā antibodies IgG a me IgM kūikawā Novel coronavirus.

ʻino:Hōʻike ʻia kahi laina kala ma ka ʻāpana hoʻomalu (C), ʻAʻohe laina kala i ʻike ʻia ma ka ʻāpana laina hoʻāʻo.

Hewa:ʻAʻole ʻike ʻia ka laina mana. ʻO ka lawa ʻole o ka nui o ka hōʻike ʻana a i ʻole nā ​​ʻenehana kaʻina hana hewa ke kumu nui loa o ka fbr control linefailure. E nānā i ke kaʻina hana a hana hou i ka hoʻāʻo me kahi pahu hoʻāʻo hou. Inā hoʻomau ka pilikia, e hoʻopau koke i ka hoʻohana ʻana i ka pahu hoʻāʻo a hoʻopili i kāu mea hoʻolaha kūloko.

HOOLAHA ANOAI

Hoʻokomo ʻia kahi mana kaʻina hana i ka hoʻāʻo. ʻIke ʻia kahi laina kala i ka ʻāpana hoʻomalu (C) he mana kaʻina hana kūloko. Hōʻoia ia i ka nui o ka specimen, lawa ka membrane wicking a me ke kaʻina hana kūpono. ʻAʻole hāʻawi ʻia nā kūlana mana me kēia kit. Eia nō naʻe, manaʻo ʻia e hoʻāʻo ʻia nā mana maikaʻi a maikaʻi ʻole ma ke ʻano he hana hoʻokolohua maikaʻi e hōʻoia i ke kaʻina hana hoʻāʻo a hōʻoia i ka hana hoʻokolohua kūpono.

KAUKA

• ʻO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) i kaupalena ʻia e hāʻawi i kahi qualitative

ʻike maka. ʻAʻole pili ka ikaika o ka laina hoʻāʻo i ka neʻe ʻana o ka antibody i loko o ke koko. ʻO nā hopena i loaʻa mai kēia hoʻāʻo ʻana i manaʻo ʻia he kōkua i ka hōʻoia wale ʻana. Pono kēlā me kēia kauka e wehewehe i nā hopena me ka moʻolelo o ka mea maʻi, nā ʻike kino, a me nā kaʻina hana diagnostic ʻē aʻe.

• Hōʻike ʻia kahi hopena hoʻāʻo maikaʻi ʻole ʻaʻole i loaʻa nā antibodies i Novel coronavirus a i ʻole nā ​​pae i ʻike ʻole ʻia e ka hoʻāʻo.

NA HIO HANA

Ka pololei

Nā ʻikepili hōʻuluʻulu o CO VID-19 IgG/IgM Rapid Test e like me lalo

E pili ana i ka hōʻike IgG, ua helu mākou i ka helu maikaʻi o nā maʻi 82 i ka wā convalescence.

COVID-19 IgG:

Loaʻa nā hopena i ka sensitivity o 97.56%

E pili ana i ka ho'āʻo IgM, ka hoʻohālikelike hopena i ka RT-PCR.

COVID-19 IgM:

Ua hana ʻia kahi hoʻohālikelike helu ma waena o nā hopena e hāʻawi ana i ka sensitivity o 88.61%, kahi kikoʻī o 97.67% a me ka pololei o 93.33%

Kea-Reactivity a me ke keakea

1. ʻO nā kumu kumu maʻamau ʻē aʻe o nā maʻi infectious i loiloi ʻia no ka reactivity cross me ka hoʻāʻo. ʻO kekahi mau hiʻohiʻona maikaʻi o nā maʻi maʻi maʻamau i hoʻopaʻa ʻia i loko o ka Novel coronavirus maikaʻi a maikaʻi ʻole a hoʻāʻo ʻia. ʻAʻole i ʻike ʻia ke ʻano o ke keʻa me nā specimens mai nā maʻi i loaʻa i ka maʻi HIV, HA^ HBsAg, HCV TP, HTIA^ CMV FLUA, FLUB, RSy MP, CP, HPIVs.

2.Potentially cross-reactive endogenous substances like common serum component, like lipids, hemoglobin, bilirubin, were spiked at high concentrations in the Novel coronavirus positive and negative specimens and ho'āʻo, kaawale.

ʻAʻole i ʻike ʻia ka hoʻololi ʻana a i ʻole ke keakea ʻana i ka hāmeʻa.

3. Ua hoʻopaʻa ʻia kekahi mau analytes olaola maʻamau i loko o ka Novel coronavirus maikaʻi a maikaʻi ʻole hoʻi a hoʻāʻo ʻia. ʻAʻole i ʻike ʻia ke keakea nui ma nā pae i helu ʻia ma ka papa ma lalo.

Hoʻopuka hou

Ua hana ʻia nā haʻawina reproducibility no Novel coronavirus IgG/IgM Rapid Test ma ʻekolu mau keʻena keʻena kauka (POL). He kanaono (60) mau hōʻailona serum lapaʻau, 20 maikaʻi ʻole, 20 palena maikaʻi a me 20 maikaʻi, i hoʻohana ʻia i kēia noiʻi. Holo ʻia kēlā me kēia hiʻohiʻona i ʻekolu mau lā ma kēlā me kēia POL. ʻO nā ʻaelike intra-assay he 100%. ʻO ka aelike ma waena o ka pūnaewele he 100 %.