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

KA MANAO ANA

ʻO ka COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) he lateral flow immunoassay i manaʻo ʻia no ka qualitative detection SARS-CoV-2 nucleocapsid antigens i loko o ka nasal swab 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.Hiki ke ʻike ʻia ka antigen ma ka nasal swab i ka wā o ka maʻi ʻeha.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.No ka hoʻohana ʻia ʻana o kēia pahu i ka home e ka poʻe kamaʻāina ma kahi hoʻonohonoho non-laboratory (e like me ka home o ke kanaka a i ʻole kekahi mau kahua kuʻuna ʻole e like me nā keʻena, nā hanana haʻuki, nā kula a me nā mea ʻē aʻe).ʻO nā hopena hoʻāʻo o kēia kit no ka hōʻike lapaʻau wale nō.Manaʻo ʻia e hana i kahi loiloi piha o ka maʻi e pili ana i nā hōʻike maʻi maʻi a me nā hoʻokolohua ʻē aʻe.

HOOLAHA

No ka β 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 (Nasal Swab) kahi immunoassay kahe lateral e pili ana i ke kumu o ka ʻenehana sandwich pālua-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.

NA ALA A ME KA MALAMA

No ka ho'āʻo ponoʻī in vitro diagnostic hoʻohana wale nō. ʻO kēia cassette tset no hoʻokahi manawa hoʻohana a ʻaʻole hiki ke hoʻohana hou a hoʻohana ʻia e nā poʻe he nui.

• Mai hoʻohana i kēia huahana ma ke kumu hoʻokahi no ka hōʻoia ʻana a haʻalele paha i ka maʻi SARS-CoV-2 a i ʻole e hōʻike i ke kūlana maʻi o COVID-19.

• E ʻoluʻolu e heluhelu i ka ʻike a pau i loko o kēia pepa ma mua o ka hoʻāʻo ʻana.

• Mai hoʻohana i kēia huahana ma hope o ka lā pau.

• 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 hoʻohana ʻia ka hoʻāʻo no nā keiki a me nā ʻōpio me kahi kanaka makua.

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

• Mai hoʻohana i ka hoʻāʻo ma nā keiki ma lalo o 2 mau makahiki.

•Pono nā keiki liʻiliʻi me ke kōkua o ke kanaka makua ʻelua.

E holoi pono i nā lima ma mua a ma hope o ka lawelawe ʻana.

HOOLAHA

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 hoʻoheheʻe i hoʻopaʻa mua ʻia:

•Sterilized Swabs: hoʻohana hoʻokahi sterile swab no ka hōʻiliʻili specimen

• Hookomo Puke

Pono nā lako akā ʻaʻole i hāʻawi ʻia

•Ka manawa

HOOLAHA A ME KA PALAPALA

• E mālama 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.

• MAI HOOMAIKAI.

KAHIKI

Loaʻa nā kiʻi i loaʻa i ka wā o ka hoʻomaka ʻana o ka hōʻailona i nā titers viral kiʻekiʻe loa;ʻO nā hiʻohiʻona i loaʻa ma hope o nā lā ʻelima o nā hōʻailona e ʻoi aku ka maikaʻi o nā hopena maikaʻi ʻole ke hoʻohālikelike ʻia me kahi hōʻike RT-PCR.ʻO ka hōʻiliʻili ʻana i nā mea hoʻohālike kūpono ʻole, ka lawelawe ʻana i nā mea hōʻailona kūpono ʻole a/a i ʻole ka lawe ʻana i nā hopena hoʻopunipuni;no laila, paipai nui ʻia ka hoʻomaʻamaʻa ʻana i ka hōʻiliʻili specimen ma muli o ke koʻikoʻi o ka maikaʻi o ka specimen e loaʻa ai nā hopena hōʻike pololei.ʻO ke ʻano hoʻohālike e ʻae ʻia no ka hoʻāʻo ʻana he ʻano hoʻohālike ihu ihu pololei i loaʻa ma ke ʻano o ka hōʻiliʻili nares ʻelua.E hoʻomākaukau i ka paipu unuhi e like me ke Kaʻina Hana Hoʻāʻo a hoʻohana i ka ʻōpala sterile i hāʻawi ʻia i loko o ka pahu no ka hōʻiliʻili ʻana.

Nasal Swab Specimen Collection

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.

[NĀ HOʻOHANA HANA]

Hana Hana Hana

No ka hoʻohālikelike ʻana i ka prerformance lapaʻau ma waena o ka COVID-19 Antigen Rapid Test Cassette a me ka PCR comparotor, 628 nasal swab i hōʻiliʻili ʻia mai nā mea maʻi i manaʻo ʻia he COVID-19. .

COVID-19 antigen		RT-PCR		Huina
COVID-19 antigen		maikaʻi	ʻinoʻino	Huina
HEO®	maikaʻi	172	0	172
HEO®	ʻinoʻino	3	453	456
Huina		175	453	628

PPA =98.28% (172/175), (95%CI: 95.08%~99.64%) NPA =100% (453/453), (95%CI: 99.34%~100%)

PPA - ʻaelike pākēneka maikaʻi (Sensitivity) NPA - ʻaelike pākēneka maikaʻi ʻole (Specificity)

Ka palena o ka ʻike (Analytical Sensitivity)

Ua hoʻohana ka haʻawina i ka moʻomeheu SARS-CoV-2 virus (Isolate USA-WA1/2020 NR- 52287), ʻo ia ka wela a hoʻoheheʻe ʻia i loko o ka nasal swab specimen.ʻO ka palena o ka ʻike (LoD) ʻo 1.0 ×10²TCID₅₀/mL.

Ka hoʻoikaika ʻana o ke keʻa

Ua loiloi ʻia ka hoʻoikaika ʻana o ke keʻa e 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 (H3N2), Influenza B (Yamagata), Influenza B ( Victoria), Adenovirus (type 1, 2, 3, 5, 7, 55), metapneumovirus kanaka,

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 ka maʻi bacteria i ka wā i hoʻāʻo ʻia ma ka neʻe ʻana o 1.0×107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Candida albicans, ʻO 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.

Hoʻopaʻa ʻana i ka meaʻai

Mucin 2%

Benzocaine 5 mg/mL Paʻakai nasal spray 15%

Oxymetazoline 15%

Tobramycin 5 μg/mL Oseltamivir phosphate 10 mg/mL

Arbidol 5 mg/mL

Fluticasone propionate 5%

Triamcinolone 10 mg/mL

ʻO ke koko holoʻokoʻa 4%

Menthol 10 mg/mL

Phenylephrine 15%

Mupirocin 10 mg/mL

ʻO Zanamivir 5 mg/mL

Ribavirin 5 mg/mL

Dexamethasone 5 mg/mL

Histamine 10 mg/mL dihydrochloride

ʻO ka hopena Hook kiʻekiʻe

Ua hoʻāʻo ʻia ka COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) a hiki i 1.0 × 10⁵ʻO TCID50/mL o ka SARS-CoV-2 i hoʻopau ʻole ʻia a ʻaʻole i ʻike ʻia kahi hopena makau kiʻekiʻe.

Papa kuhikuhi o ka hoailona