ʻO ka pahu kiʻi ʻike kumukūʻai ʻo Amain no Covid-19

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ʻO ka pahu ʻike no Covid-19

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Nā kikoʻī

[Hoʻohana ʻia]
ʻO ka AMRDT100 IgG/IgM Rapid Test Cassette he lateral flow chromatographic immunoassay no ka ʻike qualitative o nā antibodies (IgG a me IgM) i ka Novel coronavirus i ke koko holoʻokoʻa o ke kanaka / Serum / Plasma.
Hāʻawi ia i kahi kōkua i ka ʻike ʻana i ka maʻi me Novel coronavirus.

[SUMMER]
I ka hoʻomaka ʻana o Ianuali 2020, ua ʻike ʻia kahi coronavirus novel (SARS-CoV-2, i kapa ʻia ʻo 2019-nCoV) ʻo ia ka mea maʻi maʻi e hoʻomake ai i ka maʻi maʻi maʻi maʻi ma Wuhan, Kina, kahi i loaʻa ai nā maʻi mua i kā lākou hōʻailona ma Dekemaba 2019.
ʻO nā Coronaviruses nā maʻi RNA i hoʻopuʻi ʻia ma waena o nā kānaka, nā mammals ʻē aʻe, a me nā manu a ke kumu o ka hanu, enteric, hepatic, a me nā maʻi neurologic.ʻEhā mau maʻi maʻi-229E, OC43, NL63, a me HKU1 ka mea maʻamau a ke kumu maʻamau i nā hōʻailona anu maʻamau i nā poʻe immunocompetent.ʻO nā maʻi ʻelua ʻelua maʻi maʻi maʻi respiratory syndrome coronavirus (SARS-CoV) a me Middle East respiratory syndrome coronavirus (MERS-CoV) he zoonotic i kumu a ua hoʻopili ʻia i kekahi manawa maʻi make.
He zoonotic nā Coronaviruses, ʻo ia hoʻi ua hoʻouna ʻia lākou ma waena o nā holoholona a me nā kānaka.ʻO nā hōʻailona maʻamau o ka maʻi e pili ana i nā hōʻailona hanu, ke kuni, ka ʻū, ka pōkole o ka hanu a me nā pilikia hanu.I nā hihia koʻikoʻi, hiki i ka maʻi ke hoʻoulu i ka maʻi pneumonia, ka maʻi hanu acute koʻikoʻi, ka hōʻole ʻana o ka puʻupaʻa a me ka make.
ʻO nā ʻōlelo aʻoaʻo maʻamau no ka pale ʻana i ka laha ʻana o ka maʻi, ʻo ia ka holoi lima mau, uhi i ka waha a me ka ihu i ka wā e ʻu ai a me ke kihe ʻana, ka kuke ʻana i ka ʻiʻo a me nā hua manu.E hōʻalo i ka launa pū ʻana me kekahi mea e hōʻike ana i nā hōʻailona o ka maʻi hanu e like me ka ʻuʻu a me ke kiʻi ʻana.

[KUMU ]
ʻO ka AMRDT100IgG/IgM Rapid Test Cassette he immunoassay membrane qualitative e pili ana i ka immunoassay no ka ʻike ʻana i nā antibodies (IgG a me IgM) i ka Novel coronavirus i ke koko holoʻokoʻa o ke kanaka / Serum / Plasma.Aia ka cassette ho'āʻo: 1) kahi pad conjugate kala burgundy i loaʻa nā antigens recombinant envelope Novel coronavirus i hui pū ʻia me ke gula Colloid (Novel coronavirus conjugates), 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 me ka antibody IgG anti-Human Mouse.Ke hāʻawi ʻia ka nui kūpono o ka mea hōʻike hōʻike i loko o ka pūnāwai laʻana o ka cassette hoʻāʻo, neʻe ka mea hōʻike ma ka hana capillary ma o ka cassette.ʻO ka IgM anti-Novel coronavirus, inā aia i ka specimen, e hoʻopaʻa i nā conjugates Novel coronavirus.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 inā 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 loaʻa ʻole o nā laina T (IgG a me IgM) hōʻike 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.

[NĀ ALA A ME KA PALAPALA]
No nā ʻoihana mālama olakino a me nā ʻoihana ma kahi o nā kahua 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 hoʻāʻo ʻana.
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 pōʻino a mālama ʻia e like me ke ʻano o ka maʻi maʻi.
Pono e hoʻolei ʻia ka pahu hoʻāʻo i hoʻohana ʻia e like me nā kānāwai federal, mokuʻāina a kūloko.

[HUI]
Aia i loko o ka hoʻāʻo kahi ʻāpana membrane i uhi ʻia me Mouse anti-Human IgM antibody a me Mouse anti-Human IgG antibody ma ka laina hoʻāʻo, a me kahi pad dye i loko o ke gula colloidal i hui pū ʻia me Novel coronavirus recombinant antigen.
Ua paʻi ʻia ka nui o nā hoʻokolohua ma ka lepili.
Nā mea i hāʻawi ʻia
Hoʻokomo i ka cassettePackage hoʻāʻo
Hoʻopaʻa
Pono nā mea pono akā ʻaʻole i hāʻawi ʻia
ʻO ka pahu hōʻiliʻili hiʻohiʻonaTimer

[PAʻA A ME KA PAʻA]
E kūʻai e like me ka pūʻolo i loko o ka ʻeke i hoʻopaʻa ʻia i ka mahana (4-30 ℃ a i ʻole 40-86 ℉).Paʻa ka pahu i loko o ka lā pau i paʻi ʻia ma ka lepili.
Ke wehe ʻia ka ʻeke, pono e hoʻohana ʻia ka hoʻāʻo 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 e hoʻāʻo 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 hōʻailona ma 2-8 ℃ (36-46℉) inā ʻaʻole hoʻāʻo koke ʻia.E mālama i nā mea hoʻohālike ma 2-8 ℃ a hiki i 7 lā.Pono e hoʻopaʻa ʻia nā specimens ma
-20 ℃ (-4℉) no ka mālama lōʻihi.Mai hoʻokuʻu i ke koko holoʻokoʻa.
E hōʻalo i nā pōʻai hau hau.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, gross hemolysis a i ʻole turbidity i mea e pale aku ai i ka hoʻopilikia ʻana i ka wehewehe ʻana i ka hopena.

[KA HANA HO'O'O]
E ʻae i ka mea hoʻāʻo a me nā mea hoʻohālike e hoʻohālikelike i ka mahana (15-30 ℃ a i ʻole 59-86 ℉) ma mua o ka hoʻāʻo ʻana.
1. Wehe i ka pahu hoʻāʻo mai ka ʻeke i hoʻopaʻa ʻia.
2. Hoʻopaʻa i ka dropper vertically a hoʻololi i 1 kulu o ka specimen i ka specimen well (S) o ka mea ho'āʻo, a laila e hoʻohui i 2 kulu o ka buffer (ma kahi o 70μl) a hoʻomaka i ka manawa.E nānā i ke kiʻi ma lalo.
3. E kali 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.

[WAEHANA O KA HUNAHUNA]
Maikaʻi: Hōʻike ʻia ka laina hoʻokele a ma kahi o hoʻokahi laina hoʻāʻo ma ka membrane.ʻO ke ʻano o ka laina hoʻāʻo IgG e hōʻike ana i ka hele ʻana o nā antibodies IgG kikoʻī coronavirus Novel.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.
ʻAʻohe: Hoʻokahi laina kala i ʻike ʻia ma ka ʻāpana hoʻomalu (C).
He kūpono ʻole: ʻAʻole ʻike ʻia ka laina mana.ʻO ka lawa ʻole o ka nui o ka specimen a i ʻole nā ​​ʻenehana kaʻina hana hewa ke kumu nui loa o ka hemahema o ka laina hoʻokele.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.

[KUALITY MANA]
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.

[LIMITATIONS]
Ua kaupalena ʻia ka AMRDT100 IgG/IgM Rapid Test Cassette e hāʻawi i kahi ʻike kūpono.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 ka hopena hōʻike maikaʻi ʻole ʻaʻole i loaʻa nā antibodies i ka Novel coronavirus a i ʻole nā ​​pae i ʻike ʻole ʻia e ka hoʻāʻo.

[NĀ HOʻOHANA HANA]
Ka pololei
Ua hana ʻia kahi hoʻohālikelike ʻaoʻao me ka hoʻohana ʻana i ka Novel coronavirus IgG/IgM Rapid Test a me kahi PCR pāʻoihana alakaʻi.Ua loiloi ʻia he 120 mau hōʻailona mai ka Professional Point of Care.Hōʻike ʻia nā hopena ma hope mai kēia mau noiʻi lāʻau lapaʻau:
Ua hana ʻia kahi hoʻohālikelike helu ma waena o nā hopena e hāʻawi ana i ka sensitivity o 90.00%, kahi kikoʻī o 97.78% a me ka pololei o 95.83%.
Kea-Reactivity a me ke keakea
1.Other maʻamau kumu kumu o infectious maʻi i loiloi 'ia no ke kea reactivity me ka hoao ana.ʻO kekahi mau hiʻohiʻona maikaʻi o nā maʻi maʻi maʻamau i hoʻopaʻa ʻia i loko o ka Novel coronavirus maikaʻi a maikaʻi ʻole i hoʻāʻo ʻia.ʻAʻole i ʻike ʻia ke ʻano o ke keʻa me nā specimens mai nā maʻi i loaʻa i ka maʻi HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV a me TP.
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, 20 palena maikaʻi a me 20 maikaʻi, i hoʻohana ʻia i kēia noiʻi.Hoʻohana ʻia kēlā me kēia hōʻike 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 %.

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