Wholesale COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) nā mea hana a me nā mea hoʻolako |HEO

COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

ʻO ka wehewehe pōkole:

E hoʻouna i ka leka uila iā mākou Hoʻoiho ma ke ʻano he PDF

Huahana Huahana

[Hoʻohana ʻia]
ʻO ka COVID-19 Antigen Rapid Test Cassette (Saliva) he lateral flow immunoassay i manaʻo ʻia no ka qualitative detection SARS-CoV-2 nucleocapsid antigens i loko o ka wai mai nā poʻe i manaʻo ʻia he COVID-19 e kā lākou mea mālama olakino.
Loaʻa nā hopena no ka ʻike ʻana i ka SARS-CoV-2 nucleocapsid antigen.ʻIke ʻia ka antigen i loko o ka saliva i ka wā o ka maʻi maʻi.Hōʻike nā hopena maikaʻi i ka loaʻa ʻana o nā antigens viral, akā pono ka pilina pili kino me ka mōʻaukala maʻi a me nā ʻike diagnostic ʻē aʻe e hoʻoholo ai i ke kūlana maʻi.ʻAʻole ʻae nā hopena maikaʻi i ka maʻi bacterial a i ʻole ka hui pū ʻana me nā maʻi maʻi ʻē aʻe.ʻAʻole paha ʻo ka luna i ʻike ʻia ke kumu maopopo o ka maʻi.
ʻAʻole hoʻoholo nā hopena maikaʻi ʻole i ka maʻi SARS-CoV-2 a ʻaʻole pono e hoʻohana ʻia ma ke kumu hoʻokahi no ka mālama ʻana a i ʻole nā hoʻoholo hoʻokele maʻi, me nā hoʻoholo hoʻoholo maʻi.Pono e noʻonoʻo ʻia nā hopena maikaʻi ʻole i loko o ka pōʻaiapili o ka mea maʻi i hōʻike hou ʻia, ka mōʻaukala a me ka hele ʻana o nā hōʻailona lapaʻau a me nā hōʻailona e kūlike me COVID-19, a hoʻopaʻa ʻia me kahi molecular assay, inā pono no ka hoʻokele maʻi.
ʻO ka COVID-19 Antigen Rapid Test Cassette (Saliva) i manaʻo ʻia no ka hoʻohana ʻana e nā limahana lapaʻau a i ʻole nā mea hana i hoʻomaʻamaʻa ʻia i mākaukau i ka hana ʻana i nā hoʻokolohua kahe lateral.Hiki ke hoʻohana ʻia ka huahana i loko o nā hale hana a me nā ʻano hana ʻole e hoʻokō i nā koi i ʻōlelo ʻia ma nā ʻōkuhi no ka hoʻohana ʻana a me nā hoʻoponopono kūloko.
[SUMMER]
No ka p genus ka novel coronaviruses (SARS-CoV-2).ʻO COVID-19 kahi maʻi maʻi ʻeha hanu.Hiki ke maʻalahi nā kānaka.I kēia manawa, ʻo nā maʻi i loaʻa i ka coronavirus novel ke kumu nui o ka maʻi;Hiki i nā kānaka maʻi asymptomatic 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 diarrhea i kekahi mau hihia.
[KUMU ]
ʻO ka COVID-19 Antigen Rapid Test Cassette (Saliva) kahi immunoassay kahe lateral e pili ana i ke kumu o ka ʻenehana sandwich double-antibody.Hoʻohana ʻia ʻo SARS-CoV-2 nucleocapsid protein monoclonal antibody i hui pū ʻia me nā microparticles waihoʻoluʻu ma ke ʻano he mea ʻike a hoʻoheheʻe ʻia ma ka papa conjugation.I ka wā o ka hoʻāʻo, ʻo SARS-CoV-2 antigen i ka specimen e launa pū me SARS-CoV-2 antibody conjugated me nā microparticles kala e hana ana i ka antigen-antibody labeled complex.Ke neʻe nei kēia paʻakikī ma ka membrane ma o ka hana capillary a hiki i ka laina hoʻāʻo, kahi e hopu ʻia ai e ka SARS-CoV-2 nucleocapsid protein monoclonal antibody.E ʻike ʻia kahi laina hoʻāʻo kala (T) i ka puka aniani hopena inā loaʻa nā antigens SARS-CoV-2 i ka specimen.ʻO ka nele o ka laina T e hōʻike ana i kahi hopena maikaʻi ʻole.Hoʻohana ʻia ka laina hoʻomalu (C) no ka hoʻomalu ʻana i ke kaʻina hana, a pono e ʻike mau ʻia inā hana pono ke kaʻina hana hoʻāʻo.
[NĀ ALA A ME KA PALAPALA]
• No ka hoʻohana diagnostic in vitro wale nō.
• No nā poʻe ʻoihana mālama ola kino a me nā poʻe i aʻo ʻia ma nā wahi o ka mālama.
• Mai hoʻohana i kēia huahana ma ke ʻano he kumu hoʻokahi e ʻike ai a kāpae paha
ʻO ka maʻi SARS-CoV-2 a i ʻole e hoʻomaopopo i ke kūlana maʻi o COVID-19.
• Mai hoʻohana i kēia huahana ma hope o ka lā pau.
• E ʻoluʻolu e heluhelu i ka ʻike a pau i loko o kēia pepa 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 mea 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 hoʻoponopono federal, mokuʻāina a kūloko.
[HUI]
Nā mea i hāʻawi ʻia
• Nā pahu ho'āʻo: kēlā me kēia cassette me ka desiccant i loko o ka ʻeke pepa hoʻokahi
• Nā mea hoʻopaʻa hoʻihoʻi: ampoule i loaʻa i ka 0.3 mL o ka reagent unuhi
• Na Kohi Kohu
• Nā paipu hōʻiliʻili
• Nā mea hāʻule
• Hookomo Puke
Pono nā lako akā ʻaʻole i hāʻawi ʻia
•Ka manawa
[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°C a i ʻole 40-86T).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 ʻike lōʻihi i ka ʻāina wela a me ka haʻahaʻa e hōʻino ai ka huahana.
• Ua paʻi ʻia ka LOT a me ka lā pau ma ka lepili.
[OHI A ME KA HOʻomākaukau ʻana i nā SPECIMEN]
Mai waiho i kekahi mea i loko o ka waha e like me ka meaʻai, ka mea inu, ka ʻōpala a i ʻole nā huahana paka no 30 mau minuke ma mua o ka ʻohi ʻana.
E hoʻohana i ka paipu hōʻiliʻili a me ka ʻohi kohu e hōʻiliʻili i ka saliva.E hoʻokomo i ka ʻohi kohu i loko o ka paipu hōʻiliʻili, a laila e hoʻokomo i ka ʻohi kohu ma kahi kokoke i nā lehelehe a e kahe ka saliva i loko o ka pahu hōʻiliʻili.Pono ka nui o ka saliva ma ka kaha unahi (approx.300|jL).Inā ʻoi aku ka nui o ka nui o ka saliva, e hoʻohana i kahi mea hoʻoheheʻe no ka wehe ʻana i ke kohu keu a hiki i ka hopena hope loa ma ka māka unahi (ma kahi o 300pL).[Hoʻohana ʻia]
ʻO ka COVID-19 Antigen Rapid Test Cassette (Saliva) he lateral flow immunoassay i manaʻo ʻia no ka qualitative detection SARS-CoV-2 nucleocapsid antigens i loko o ka wai mai nā poʻe i manaʻo ʻia he COVID-19 e kā lākou mea mālama olakino.
Loaʻa nā hopena no ka ʻike ʻana i ka SARS-CoV-2 nucleocapsid antigen.ʻIke ʻia ka antigen i loko o ka saliva i ka wā o ka maʻi maʻi.Hōʻike nā hopena maikaʻi i ka loaʻa ʻana o nā antigens viral, akā pono ka pilina pili kino me ka mōʻaukala maʻi a me nā ʻike diagnostic ʻē aʻe e hoʻoholo ai i ke kūlana maʻi.ʻAʻole ʻae nā hopena maikaʻi i ka maʻi bacterial a i ʻole ka hui pū ʻana me nā maʻi maʻi ʻē aʻe.ʻAʻole paha ʻo ka luna i ʻike ʻia ke kumu maopopo o ka maʻi.
ʻAʻole hoʻoholo nā hopena maikaʻi ʻole i ka maʻi SARS-CoV-2 a ʻaʻole pono e hoʻohana ʻia ma ke kumu hoʻokahi no ka mālama ʻana a i ʻole nā hoʻoholo hoʻokele maʻi, me nā hoʻoholo hoʻoholo maʻi.Pono e noʻonoʻo ʻia nā hopena maikaʻi ʻole i loko o ka pōʻaiapili o ka mea maʻi i hōʻike hou ʻia, ka mōʻaukala a me ka hele ʻana o nā hōʻailona lapaʻau a me nā hōʻailona e kūlike me COVID-19, a hoʻopaʻa ʻia me kahi molecular assay, inā pono no ka hoʻokele maʻi.
ʻO ka COVID-19 Antigen Rapid Test Cassette (Saliva) i manaʻo ʻia no ka hoʻohana ʻana e nā limahana lapaʻau a i ʻole nā mea hana i hoʻomaʻamaʻa ʻia i mākaukau i ka hana ʻana i nā hoʻokolohua kahe lateral.Hiki ke hoʻohana ʻia ka huahana i loko o nā hale hana a me nā ʻano hana ʻole e hoʻokō i nā koi i ʻōlelo ʻia ma nā ʻōkuhi no ka hoʻohana ʻana a me nā hoʻoponopono kūloko.
[SUMMER]
No ka p genus ka novel coronaviruses (SARS-CoV-2).ʻO COVID-19 kahi maʻi maʻi ʻeha hanu.Hiki ke maʻalahi nā kānaka.I kēia manawa, ʻo nā maʻi i loaʻa i ka coronavirus novel ke kumu nui o ka maʻi;Hiki i nā kānaka maʻi asymptomatic 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 diarrhea i kekahi mau hihia.
[KUMU ]
ʻO ka COVID-19 Antigen Rapid Test Cassette (Saliva) kahi immunoassay kahe lateral e pili ana i ke kumu o ka ʻenehana sandwich double-antibody.Hoʻohana ʻia ʻo SARS-CoV-2 nucleocapsid protein monoclonal antibody i hui pū ʻia me nā microparticles waihoʻoluʻu ma ke ʻano he mea ʻike a hoʻoheheʻe ʻia ma ka papa conjugation.I ka wā o ka hoʻāʻo, ʻo SARS-CoV-2 antigen i ka specimen e launa pū me SARS-CoV-2 antibody conjugated me nā microparticles kala e hana ana i ka antigen-antibody labeled complex.Ke neʻe nei kēia paʻakikī ma ka membrane ma o ka hana capillary a hiki i ka laina hoʻāʻo, kahi e hopu ʻia ai e ka SARS-CoV-2 nucleocapsid protein monoclonal antibody.E ʻike ʻia kahi laina hoʻāʻo kala (T) i ka puka aniani hopena inā loaʻa nā antigens SARS-CoV-2 i ka specimen.ʻO ka nele o ka laina T e hōʻike ana i kahi hopena maikaʻi ʻole.Hoʻohana ʻia ka laina hoʻomalu (C) no ka hoʻomalu ʻana i ke kaʻina hana, a pono e ʻike mau ʻia inā hana pono ke kaʻina hana hoʻāʻo.
[NĀ ALA A ME KA PALAPALA]
• No ka hoʻohana diagnostic in vitro wale nō.
• No nā poʻe ʻoihana mālama ola kino a me nā poʻe i aʻo ʻia ma nā wahi o ka mālama.
• Mai hoʻohana i kēia huahana ma ke ʻano he kumu hoʻokahi e ʻike ai a kāpae paha
ʻO ka maʻi SARS-CoV-2 a i ʻole e hoʻomaopopo i ke kūlana maʻi o COVID-19.
• Mai hoʻohana i kēia huahana ma hope o ka lā pau.
• E ʻoluʻolu e heluhelu i ka ʻike a pau i loko o kēia pepa 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 mea 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 hoʻoponopono federal, mokuʻāina a kūloko.
[HUI]
Nā mea i hāʻawi ʻia
• Nā pahu ho'āʻo: kēlā me kēia cassette me ka desiccant i loko o ka ʻeke pepa hoʻokahi
• Nā mea hoʻopaʻa hoʻihoʻi: ampoule i loaʻa i ka 0.3 mL o ka reagent unuhi
• Na Kohi Kohu
• Nā paipu hōʻiliʻili
• Nā mea hāʻule
• Hookomo Puke
Pono nā lako akā ʻaʻole i hāʻawi ʻia
•Ka manawa
[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°C a i ʻole 40-86T).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 ʻike lōʻihi i ka ʻāina wela a me ka haʻahaʻa e hōʻino ai ka huahana.
• Ua paʻi ʻia ka LOT a me ka lā pau ma ka lepili.
[OHI A ME KA HOʻomākaukau ʻana i nā SPECIMEN]
Mai waiho i kekahi mea i loko o ka waha e like me ka meaʻai, ka mea inu, ka ʻōpala a i ʻole nā huahana paka no 30 mau minuke ma mua o ka ʻohi ʻana.
E hoʻohana i ka paipu hōʻiliʻili a me ka ʻohi kohu e hōʻiliʻili i ka saliva.E hoʻokomo i ka ʻohi kohu i loko o ka paipu hōʻiliʻili, a laila e hoʻokomo i ka ʻohi kohu ma kahi kokoke i nā lehelehe a e kahe ka saliva i loko o ka pahu hōʻiliʻili.Pono ka nui o ka saliva ma ka kaha unahi (approx.300|jL).Inā ʻoi aku ka nui o ka nui o ka saliva, e hoʻohana i kahi mea hoʻoheheʻe no ka wehe ʻana i ke kohu keu a hiki i ka hopena hope loa ma ka māka unahi (ma kahi o 300pL).

Ka lawe ʻana a me ka mālama ʻana i nā mea hoʻohālike

Pono e hana ʻia nā mea hōʻiliʻili hou i ka wā hiki, akā ʻaʻole ma mua o hoʻokahi hola ma hope o ka hōʻiliʻili ʻana.

[KA HANA HO'O'O]

'Ōlelo Aʻo: E ʻae i nā cassettes hoʻāʻo, reagents a me nā specimens e hoʻohālikelike i ka mahana lumi (15-30°C a i ʻole 59-86T) ma mua o ka hoʻāʻo ʻana.

E kau i ka paipu hōʻiliʻili me ka ʻohi kohu i loaʻa ka kohu ma ke kahua hana.Wehe i ke poʻi o kahi mea hoʻoheheʻe hoʻoheheʻe.E hoʻohui i nā mea hoʻoheheʻe a pau i loko o ka paipu hōʻiliʻili.

E hoolei i ka ohi kohu;E uhi i ka paipu hōʻiliʻili me ka piko kulu ma luna o ka paipu hōʻiliʻili.E lulu i ka paipu ohi ma mua o ekolu manawa me ka ikaika e hui ai i ka saliva a me ka mea ho'ohehe'e unuhi, a laila e kaomi i ka wai i hui 'ia he 'umi manawa e hui pono ai ka saliva.

Wehe i ka pahu hoʻāʻo mai ka ʻeke i hoʻopaʻa ʻia.

E hoʻohuli i ka paipu hōʻiliʻili, e hoʻopaʻa pololei i ka paipu, e hoʻololi mālie i 3 kulu (ma kahi o 100pL) i ka pūnāwai specimen (S) o ka pahu hoʻāʻo, a laila hoʻomaka i ka manawa.

E kali a ʻike ʻia 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]
Pono \|	§	Hōʻike ʻia nā laina ʻelua.Hōʻike ʻia kekahi laina kala i ka H c ma ka ʻāpana hoʻomalu (C), a ʻo kekahi kala Jt\|jne ma ka wahi hoao (T), me ka nana ole i ka ikaika o ka laina hoao.
ʻinoʻino		Hōʻike ʻia kekahi laina kala ma ka ʻāpana hoʻomalu (C), a ʻaʻohe laina i ʻike ʻia ma ka ʻāpana hoʻāʻo (T).
He kūpono ʻole		ʻAʻole ʻike ʻia ka laina mana.ʻAʻole lawa、ʻO ka nui o nā hiʻohiʻona a i ʻole ke kaʻina hana hewa ʻo 5 nā ʻenehana ke kumu nui loa o ka hemahema o ka laina mana.E nānā i ke kaʻina hana a me Jte hana hou i ka ho'āʻo me ka hoʻohana ʻana i ka pahu hoʻāʻo hou.InaJ)Ke hoʻomau nei ka pilikia, hoʻopau koke i ka hoʻohana ʻana i ka hailona 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 ai i ke kaʻina hana hoʻāʻo a no ka hana hoʻokolohua kūpono.

[LIMITATIONS]

Ua kaupalena ʻia ka huahana e hāʻawi i kahi ʻike qualitative.ʻAʻole pili ka ikaika o ka laina hoʻāʻo i ka ʻike o ka antigen o nā mea hoʻohālike.
ʻAʻole ʻae ʻia nā hopena maikaʻi ʻole i ka maʻi SARS-CoV-2 a ʻaʻole pono e hoʻohana ʻia ma ke kumu hoʻokahi no nā hoʻoholo hoʻokele maʻi.
Pono ke kauka e wehewehe i nā hopena me ka moʻolelo o ka mea maʻi, nā ʻike kino, a me nā kaʻina hana diagnostic ʻē aʻe.
Hiki ke loaʻa kahi hopena maikaʻi ʻole inā ʻo ka nui o nā antigens SARS-CoV-2 i loaʻa i loko o ka specimen ma lalo o ka paepae ʻike o ka assay, a i ʻole ua loaʻa ka maʻi i ka mutation (s) amino acid liʻiliʻi ma ka ʻāpana epitope i ʻike ʻia e nā antibodies monoclonal. hoʻohana ʻia i ka hoʻāʻo.

[NĀ HOʻOHANA HANA]

Hana Hana Hana

Ua hoʻokumu ʻia ka hana lapaʻau o COVID-19 Antigen Rapid Test Cassette (Saliva) i nā haʻawina e pili ana me nā specimens i hōʻiliʻili ʻia mai 628 mau maʻi maʻi maʻi (i loko o 7 mau lā o ka hoʻomaka ʻana) a me nā mea maʻi asymptomatic i manaʻo ʻia he COVID-19.

ʻO ka ʻikepili hōʻuluʻulu o COVID-19 Antigen Rapid Test e like me lalo:

ʻO ka paepae pōʻaiapuni RT-PCR (Ct) ka waiwai hōʻailona kūpono.Hōʻike ka waiwai Ct haʻahaʻa i ka hoʻouka viral kiʻekiʻe.Ua helu ʻia ka naʻau no ka pae waiwai Ct like ʻole (Ct valueW37)

Antfgeno COVID-19		RT-PCR		Huina
Antfgeno COVID-19		Positivo	Negativo	Huina
HEO®	Positivo	172	0	172
HEO®	Negativo	3	453	456
Huina		175	453	628

Kuikahi pākēneka maikaʻi(PPA)=98.28%(172/175),(95%CI:95.08%~99.41%)

Kuikahi pākēneka ʻino(NPA)=100%(453/453),(95%CI:99.15%~100%)

PPA - Kuikahi pākēneka maikaʻi (Sensitivity)

NPA - ʻAelike pākēneka ʻino (Specificity)

Ka palena o ka ʻike (Analytical Sensitivity)

Ua hoʻohana ke aʻo ʻana i ka moʻomeheu SARS-CoV-2 virus (Isolate Hong Kong/VM20001061/2020, NR-52282), ʻo ia ka wela a hoʻoulu ʻia i loko o ka pala.ʻO ka palena o ka ʻike (LoD) ʻo 8.6 X10²TCIDso/mL.

Ka hoʻoikaika ʻana o ke keʻa

Ua loiloi ʻia ka hoʻoikaika ʻana o ke keʻa ma o ka hoʻāʻo ʻana i 32 commensal a me pathogenic microorganisms i loaʻa i loko o ka waha.

ʻAʻole i ʻike ʻia ka cross-reactivity me ka recombinant MERS-CoV NP protein i ka wā i hoʻāʻo ʻia ma ka ʻike o 50 pg/mL.

ʻAʻole i ʻike ʻia ka cross-reactivity me nā maʻi maʻi aʻe i ka wā i hoʻāʻo ʻia ma ke ʻano o 1.0x10⁶PFU/mL: Influenza A (H1N1), Influenza A

(H1N1 pdm09), Influenza A(H3N2), Influenza B(Yamagata), Influenza B(Victoria), Adenovirus (type 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus (type 1,2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

ʻAʻole i ʻike ʻia ka cross-reactivity me ka maʻi bacteria i ka wā i hoʻāʻo ʻia ma ka neʻe ʻana o 1.0x10' CFU/mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Candida albicans.Staphylococcus. aureus.

Keakea

Ua loiloi ʻia nā mea hiki ke hoʻopilikia ʻia me ka COVID-19 Antigen Rapid Test Cassette (Saliva) ma nā ʻike i helu ʻia ma lalo nei a ua ʻike ʻia ʻaʻole pili i ka hana tegt.

mea waiwai	Hoʻopaʻa	mea waiwai	Hoʻopaʻa
Mucin	2%	ʻO ke koko holoʻokoʻa	4%
ʻO Benzocaine	5 mg/mL	Menthol	10 mg/mL
Paʻi ihu paʻakai	15%	Phenylephrine	15%
Oxymetazoline	15%	ʻO ka histamine dihydrochloride	10 mg/mL
ʻO Tobramycin	5 pg/mL	ʻO Mupirocin	10 mg/mL
Oseltamivir phosphate	10 mg/mL	ʻO Zanamivir	5 mg/mL
Arbidol	5 mg/mL	ʻO Ribavirin	5 mg/mL
Fluticasone propionate	5%	ʻO Dexamethasone	5 mg/mL
Triamcinolone	10 mg/mL

ʻO ka hopena Hook kiʻekiʻe

Ua hoʻāʻo ʻia ka COVID-19 Antigen Rapid Test Cassette (Saliva) a hiki i ka 1.15x1 o' TCIDso/mL o ka SARS-CoV-2 i hoʻopaʻa ʻole ʻia a ʻaʻohe hopena makau kiʻekiʻe i ʻike ʻia.

ʻO Hangzhou Heo Technology Co., Ltd.

Kahi helu:Room201, Building3, No.2073 Jinchang Road,

Alanui Liangzhu, Apana Yuhang, Hangzhou, Kina Helu leka uila:311113

Tel: 0086-571-87352763 E-leka uila:52558565@qq.com

Lotus NL BV Address:Koningin Julianaplein 10, le Verd,

2595AA, Hague, Holani.E-mail:Peter@lotusnl.com

Tel: +31644168999

1. Wehe i ka swab mai ka pūʻolo.

2.Tilt poʻo maʻi i hope ma kahi o 70°.

3.1-2 I ka hoʻololi mālie ʻana i ka swab, e hoʻokomo i ka swab ma kahi o 2.5 kenimika (1 ʻīniha) i loko o ka puka ihu a hiki i ka loaʻa ʻana o ke kūʻē ʻana i nā turbinates.

4. E hoʻohuli i ka swab i nā manawa he nui i ka paia ihu a hana hou i loko o ka puka ihu ʻē aʻe me ka hoʻohana ʻana i ka swab like.

Ka lawe ʻana a me ka mālama ʻana i nā mea hoʻohālike

Mai hoʻihoʻi i ka pulupulu i ka puʻupuʻu kumu.Pono e hana ʻia nā mea hōʻiliʻili hou i ka wā hiki, akā ʻaʻole ma mua o hoʻokahi hola ma hope o ka hōʻiliʻili ʻana.

HANA HO'O

Nānā:E ʻae i nā cassettes hoʻāʻo, reagents a me nā specimens e hoʻohālikelike i ka wela lumi (15-30 ℃ a i ʻole 59-86℉) ma mua o ka hoʻāʻo ʻana.

1. E kau i ka paipu unuhi ma ka hale hana.

2. Peel off aluminum foil seal mai ka piko o ka paipu unuhi i loko o ka paipu unuhi i loko o ka pahu ho'opa'a.

3. E pili ana ka laʻana i ka ʻāpana 'Specimen Collection'.

4. E hoʻokomo i ka nasal swab specimen i loko o ka pahu hoʻoheheʻe i loaʻa ka reagent.E ʻōwili i ka swab ma ka liʻiliʻi he 5 manawa me ke kaomi ʻana i ke poʻo i lalo a me ka ʻaoʻao o ka paipu unuhi.E waiho i ka pulupulu ihu i loko o ka paipu unuhi no hoʻokahi minuke.

5. Wehe i ka nasal swab i ka wā e ʻomi ai i nā ʻaoʻao o ka paipu no ka unuhi ʻana i ka wai mai ka swab.E hoʻohana ʻia ka hopena i unuhi ʻia ma ke ʻano hoʻāʻo.6. E uhi paʻa i ka paipu hoʻoheheʻe me ka piko dropper.

7. Wehe i ka pahu hoʻāʻo mai ka ʻeke i hoʻopaʻa ʻia.

8. E hoʻohuli i ka paipu hoʻoheheʻe specimen, e hoʻopaʻa pololei i ka paipu, e hoʻoneʻe mālie i 3 kulu (ma kahi o 100 μL) i ka pūnāwai specimen (S) o ka cassette hoʻāʻo, a laila hoʻomaka i ka manawa.

9. 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.

KA WAIWAI O NA HUNAHUNA

maikaʻi

C T

Hōʻike ʻia nā laina ʻelua.Hoʻokahi laina kala i ʻike ʻia i ka ikaika o ka laina hoʻāʻo.

ʻinoʻino

Hōʻike ʻia kekahi laina kala ma ka ʻāpana hoʻomalu (C), a ʻaʻohe laina i ʻike ʻia ma ka ʻāpana hoʻāʻo (T).

He kūpono ʻole

C T

Manao laina hāʻule to puka mai. 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 noʻonoʻo i ke kaʻina hana a hana hou i ka hoʻāʻo me ka hoʻohana ʻana i kahi cassette hoʻāʻo hou.Inā hoʻomau ka pilikia, e hoʻopau koke i ka hoʻohana ʻana i ka hailona a e kelepona i kāu mea hoʻolaha kūloko.

KA MANA ANOAI

ʻAʻole hāʻawi ʻia nā kūlana mana me kēia kit.Eia nō naʻe, manaʻo ʻia e hoʻāʻo ʻia nā mana maikaʻi a me ka maikaʻi ʻole ma ke ʻano he hana hoʻokolohua maikaʻi e hōʻoia i ke kaʻina hana hoʻāʻo a hōʻoia i ka hana hoʻokolohua kūpono.

KAUKA

• Ua kaupalena ʻia ka huahana e hāʻawi i kahi ʻike qualitative.ʻAʻole pili ka ikaika o ka laina hoʻāʻo i ka ʻike o ka antigen o nā mea hoʻohālike.

• ʻAʻole hiki i nā hopena maikaʻi ʻole ke pale i ka maʻi SARS-CoV-2 a inā loaʻa nā hōʻailona pono ʻoe e ʻimi koke i ka hoʻāʻo hou ʻana ma o ka PCR Method.

• Pono ke kauka e wehewehe i nā hopena me ka moʻolelo o ka mea maʻi, nā ʻike kino, a me nā kaʻina hana diagnostic ʻē aʻe.

• Pono e hōʻoia ʻia kahi hopena maikaʻi ʻole mai kēia Kit e PCR.Hiki ke loaʻa kahi hopena maikaʻi ʻole inā ʻo ka nui o nā antigens SARS-CoV-2 i loaʻa i loko o ka specimen ma lalo o ka paepae ʻike o ka assay, a i ʻole ua loaʻa ka maʻi i ka mutation (s) amino acid liʻiliʻi ma ka ʻāpana epitope i ʻike ʻia e nā antibodies monoclonal. hoʻohana ʻia i ka hoʻāʻo.

• Hiki ke hoʻopilikia i ke koko a i ʻole ka ʻūhū ma luna o ke ʻano o ka swab i ka hana ʻana a hiki ke hāʻawi mai i nā hopena maikaʻi ʻole.

NA HIO HANA

Hana Hana Hana

COVID-19 antigen		RT-PCR		Totale
COVID-19 antigen		maikaʻi	ʻinoʻino	Totale
HEO®	maikaʻi	212	0	212
HEO®	ʻinoʻino	3	569	572
Huina		215	569	784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)

PPA - ʻAelike pākēneka maikaʻi (Sensitivity) NPA - Kuʻikahi pākēneka maikaʻi ʻole (Specificity) 95% *Nā manawa hilinaʻi.

Nā lā mai ka hōʻailona	RT-PCR	HEO ʻenehana	ʻaelike(%)
0-3	95	92	96.84%
4-7	120	120	100%

CT Waiwai	RT-PCR	HEO ʻenehana	ʻaelike(%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
<37	9	7	77.78%

Ka palena o ka ʻike (Analytical Sensitivity)

Ua hoʻohana ka haʻawina i ka maʻi maʻi SARS-CoV-2 moʻomeheu, ʻaʻole i hoʻāla ʻia ka wela a hoʻopaʻa ʻia i loko o ka nasal swab specimen.ʻO ka palena o ka ʻike (LoD) ʻo 1.0 ×102 TCID50/mL.

Ka hoʻoikaika ʻana o ke keʻa

Ua loiloi ʻia ka hoʻoikaika ʻana o ke keʻa ma o ka hoʻāʻo ʻana i 32 commensal a me nā microorganism pathogenic i loaʻa i loko o ka lua ihu.ʻAʻole i ʻike ʻia ka cross-reactivity me ka recombinant MERS-CoV NP protein i ka wā i hoʻāʻo ʻia ma ka ʻike o 50 pg/mL.

ʻAʻole i ʻike ʻia ka cross-reactivity me nā maʻi maʻi i ka wā i hoʻāʻo ʻia ma ka ʻike o 1.0×106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H7N9), Influenza A (H3N2), Influenza B ( Yamagata), Influenza B (Victoria), Adenovirus (type 1, 2, 3, 5, 7, 55), Human metapneumovirus,

ʻO ka maʻi parainfluenza (type 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

ʻAʻole i ʻike ʻia ka cross-reactivity me kēia bacteria i ka wā i hoʻāʻo ʻia ma ka ʻike o 1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Candida albicans Staphylococcus aureus.

Keakea

Ua loiloi ʻia nā mea hiki ke hoʻopilikia ʻia me ka COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ma nā ʻano i helu ʻia ma lalo nei a ua ʻike ʻia ʻaʻole ia e pili i ka hana hoʻokolohua.

mea waiwai	Hoʻopaʻa	mea waiwai	Hoʻopaʻa
Mucin	2%	ʻO ke koko holoʻokoʻa	4%
ʻO Benzocaine	5 mg/mL	Menthol	10 mg/mL
Paʻi ihu paʻakai	15%	Phenylephrine	15%
Oxymetazoline	15%	ʻO Mupirocin	10 mg/mL
ʻO Tobramycin	5 μg/mL	ʻO Zanamivir	5 mg/mL
Oseltamivir phosphate	10 mg/mL	ʻO Ribavirin	5 mg/mL
Arbidol	5 mg/mL	ʻO Dexamethasone	5 mg/mL
Fluticasone propionate	5%	Histamine dihydrochloride	10 mg/mL
Triamcinolone	10 mg/mL	Histamine dihydrochloride	10 mg/mL

ʻO ka hopena Hook kiʻekiʻe

ʻO ka COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) ua hoʻāʻo ʻia a hiki i 1.0 × 10 5 TCID50 /mL o ka SARS-CoV-2 inactivated a ʻaʻole i ʻike ʻia kahi hopena hook kiʻekiʻe.

Nīnau pinepine

1. Pehea ka hana ʻana o ka SARS-CoV-2 Antigen Rapid Test?ʻO ka hoʻāʻo ʻana no ka ʻike qualitative o nā antigens SARS-CoV-2 i nā ʻāpana swab hōʻiliʻili ponoʻī.Hōʻike ka hopena maikaʻi i nā antigens SARS-CoV-2 i loko o ka specimen.

I ka manawa hea e hoʻohana ʻia ai ka hoʻāʻo?

Hiki ke ʻike ʻia ka antigen SARS-CoV-2 i ka maʻi ʻeha o ka ʻōpū hanu, ua ʻōlelo ʻia e holo i ka hoʻāʻo i ka wā o nā hōʻailona me ka hoʻomaka koke ʻana o ka liʻiliʻi o kekahi o kēia mau mea: ka ʻu, ke kuni, ka hanu, ka luhi, ka emi ʻana o ka makemake, myalgia.

Ua hewa paha ka hopena?

Ua pololei nā hopena e like me ka mālama pono ʻana i nā kuhikuhi.Eia nō naʻe, ʻaʻole pololei ka hopena inā ʻaʻole lawa ka nui o ka laʻana a i ʻole ka wai o ka SARS-CoV-2 Antigen Rapid Test ma mua o ka hoʻokō ʻana i ka hoʻāʻo, a i ʻole ka nui o nā hāʻule o ka buffer extraction ma lalo o 3 a ʻoi aku paha ma mua o 4. Eia kekahi, ma muli o nā loina immunological. pili, aia nā manawa o nā hopena wahaheʻe i nā hihia liʻiliʻi.Manaʻo mau ʻia kahi kūkākūkā me ke kauka no ia mau hoʻokolohua e pili ana i nā loina immunological.

Pehea e wehewehe ai i ka ho'āʻo inā ʻokoʻa ke kala a me ka ikaika o nā laina?ʻAʻole koʻikoʻi ke kala a me ka ikaika o nā laina no ka wehewehe ʻana i ka hopena.Pono nā laina e like wale nō a ʻike maopopo ʻia.Pono e noʻonoʻo ʻia ka hoʻāʻo ma ke ʻano he mea maikaʻi ke ʻano o ke kala kala o ka laina hoʻāʻo.5. He aha kaʻu e hana ai inā maikaʻi ʻole ka hopena?

ʻO ka hopena maikaʻi ʻole ʻo ia ka maikaʻi ʻole a i ʻole he haʻahaʻa loa ka viral load

i ʻike ʻia e ka hoʻāʻo.Eia nō naʻe, hiki i kēia hoʻāʻo ke hāʻawi i kahi hopena maikaʻi ʻole i pololei ʻole (he hewa hewa) i kekahi poʻe me COVID-19.ʻO ia ke ʻano hiki ke loaʻa iā ʻoe ka COVID-19 ʻoiai ʻaʻole maikaʻi ka hōʻike.

Inā ʻike ʻoe i nā hōʻailona e like me ke poʻo, ka migraines, ke kuni, ka nalowale o ka ʻono a me ka ʻono, e kelepona i ke keʻena olakino kokoke loa me ka hoʻohana ʻana i nā lula o kou mana kūloko.Eia hou, hiki iā ʻoe ke hana hou i ka hoʻāʻo me kahi pahu hōʻike hou.I ka hihia o ka kānalua, e hana hou i ka hoʻāʻo ma hope o 1-2 mau lā, no ka mea ʻaʻole hiki ke ʻike pololei ʻia ka coronavirus ma nā wahi āpau o kahi maʻi.Pono e mālama ʻia nā lula mamao a me ka maʻemaʻe.ʻOiai me kahi hopena hoʻāʻo maikaʻi ʻole, pono e mālama ʻia nā lula mamao a me ka maʻemaʻe, ka neʻe ʻana/kaʻahele, ka hele ʻana i nā hanana a me nā mea ʻē aʻe e hahai i kāu mau alakaʻi COVID/koi.6. He aha kaʻu e hana ai inā maikaʻi ka hopena?

ʻO kahi hopena maikaʻi ʻo ia ka hele ʻana o nā antigens SARS-CoV-2.ʻO nā hopena maikaʻi ʻo ia hoʻi, loaʻa iā ʻoe ka COVID-19.E hele koke i kahi noho kaʻawale e like me nā alakaʻi kūloko a e hoʻopili koke i kāu kauka lapaʻau / kauka a i ʻole ke keʻena olakino kūloko e like me nā ʻōlelo aʻoaʻo a kou mau luna kūloko.E nānā ʻia kāu hopena hōʻike e kahi hōʻoia hōʻoia PCR a e wehewehe ʻia ʻoe i nā pae aʻe.