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COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

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AMFANI DA NUFIN

The COVID-19 Antigen Rapid Cassette (Colloidal Gold) immunoassay ne mai gudana na gefe wanda aka yi niyya don gano ƙimar SARS-CoV-2 nucleocap-sid antigens a cikin hancin swab daga mutanen da ake zargin COVID-19 ta hanyar mai ba da kiwon lafiya.

Sakamako shine don gano SARS-CoV-2 nucleocapsid antigen.Ana iya gano antigen gabaɗaya a cikin swab na hanci yayin babban lokacin kamuwa da cuta.Sakamakon sakamako mai kyau yana nuna kasancewar antigens na hoto, amma haɗin gwiwar asibiti tare da tarihin haƙuri da sauran bayanan bincike ya zama dole don sanin matsayin kamuwa da cuta.Kyakkyawan sakamako baya kawar da kamuwa da cutar kwayan cuta ko kamuwa da cuta tare da wasu ƙwayoyin cuta.Wakilin da aka gano bazai zama tabbataccen dalilin cutar ba.

Sakamako mara kyau baya kawar da kamuwa da cuta ta SARS-CoV-2 kuma bai kamata a yi amfani da shi azaman tushen kawai don magani ko yanke shawarar sarrafa haƙuri ba, gami da yanke shawarar sarrafa kamuwa da cuta.Ya kamata a yi la'akari da sakamako mara kyau a cikin mahallin bayyanar majiyyaci kwanan nan, tarihi da kasancewar alamun asibiti da alamomin da suka yi daidai da COVID-19, kuma an tabbatar da su tare da ƙididdigar ƙwayoyin cuta, idan ya cancanta don sarrafa haƙuri.Wannan kit ɗin don amfanin gida ne ta ƴan ƙasa a wurin da ba na dakin gwaje-gwaje ba (kamar gidan mutum ko wasu wuraren da ba na al'ada ba kamar ofisoshi, abubuwan wasanni, makarantu da sauransu).Sakamakon gwajin wannan kit ɗin don nunin asibiti ne kawai.Ana ba da shawarar yin nazari mai zurfi game da yanayin bisa ga bayyanar cututtuka na marasa lafiya da sauran gwaje-gwajen dakin gwaje-gwaje.

TAKAITACCEN

Novel coronaviruses (SARS-CoV-2) na cikin nau'in β.COVID-19 cuta ce mai saurin kamuwa da numfashi.Mutane gabaɗaya suna da sauƙi.A halin yanzu, marasa lafiya da suka kamu da cutar sankara ta coronavirus sune babban tushen kamuwa da cuta;Mutanen da suka kamu da asymptomatic suma suna iya zama tushen kamuwa da cuta.Dangane da binciken cututtukan cututtuka na yanzu, lokacin shiryawa shine kwanaki 1 zuwa 14, galibi daga kwanaki 3 zuwa 7.Babban bayyanar cututtuka sun haɗa da zazzabi, gajiya da bushewar tari.Ana samun cunkoso na hanci, hanci, ciwon makogwaro, myalgia da gudawa a wasu lokuta.

KA'IDA

COVID-19 Antigen Rapid Cassette (Nasal Swab) immunoassay ne mai gudana ta gefe wanda ya dogara da ka'idar fasahar sanwici mai cutarwa biyu.SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated tare da microparticles launi ana amfani dashi azaman ganowa kuma ana fesa akan kushin haɗuwa.Yayin gwajin, SARS-CoV-2 antigen a cikin samfurin yana hulɗa tare da rigakafin SARS-CoV-2 wanda aka haɗa tare da microparticles masu launi suna yin alamar antigen-antigen mai rikitarwa.Wannan hadaddun yana yin ƙaura akan membrane ta hanyar aikin capillary har zuwa layin gwaji, inda za a kama shi ta hanyar riga-kafin SARS-CoV-2 nucleocapsid protein monoclonal antibody.Za a iya ganin layin gwaji mai launi (T) a cikin taga sakamakon idan SARS-CoV-2 antigens suna cikin samfurin.Rashin layin T yana nuna sakamako mara kyau.Ana amfani da layin sarrafawa (C) don sarrafa tsari, kuma ya kamata koyaushe ya bayyana idan an yi aikin gwajin da kyau.

GARGADI DA TSIRA

• Don gwajin kai a cikin vitro diagnostic amfani kawai. Wannan kaset na tset na amfani ne na lokaci ɗaya kuma mutane da yawa ba za su iya sake amfani da su ko amfani da su ba.

•Kada kayi amfani da wannan samfurin azaman tushen kawai don ganowa ko ware kamuwa da cutar SARS-CoV-2 ko don sanar da yanayin kamuwa da cuta na COVID-19.

Da fatan za a karanta duk bayanan da ke cikin wannan takarda kafin yin gwajin.

•Kada kayi amfani da wannan samfurin bayan ranar karewa.

•Kaset ɗin gwajin ya kasance a cikin jakar da aka rufe har sai an yi amfani da shi.

Yakamata a yi la'akari da duk samfuran masu haɗari kuma a sarrafa su kamar yadda masu kamuwa da cuta suke.

•Ya kamata a yi amfani da gwajin yara da matasa tare da babba.

•Ya kamata a yi watsi da kaset ɗin gwajin da aka yi amfani da shi bisa ga dokokin tarayya, jihohi da na gida.

•Kada kayi amfani da gwajin akan yara 'yan kasa da shekaru 2.

•Ya kamata a rika shafawa kanana yara da taimakon wani babba na biyu.

•A wanke hannaye sosai kafin da bayan mu'amala.

KYAUTA

An Samar da Kayayyakin

• Gwada Cassettes: kowane kaset tare da desiccant a cikin jakar foil guda ɗaya

•Masu Shirye-Shiryen Reagent Extraction:

•Sterilized Swabs: amfani da bakararre swab guda ɗaya don tarin samfuri

• Saka Kunshin

Kayayyakin da ake buƙata amma ba a ba su ba

• Mai ƙidayar lokaci

AJIYA DA KWANTA

• Adana kamar yadda aka kunshe a cikin jakar da aka rufe a zazzabi (4-30 ℃ ko 40-86 ℉).Kayan ya tsaya tsayin daka a cikin ranar karewa da aka buga akan lakabin.

•Da zarar an bude jakar, sai a yi amfani da gwajin cikin awa daya.Tsawaita bayyanawa ga yanayin zafi da ɗanɗano zai haifar da lalacewar samfur.

•KADA KA DAKE.

NASARA

Samfuran da aka samu da wuri yayin bayyanar cutar za su ƙunshi mafi girman titers na hoto ko bidiyo mai zagaya yanar gizo da sauri;samfurori da aka samu bayan kwanaki biyar na bayyanar cututtuka suna iya haifar da mummunan sakamako idan aka kwatanta da gwajin RT-PCR.Rashin isassun samfurori, sarrafa samfuran da bai dace ba da/ko jigilar kayayyaki na iya haifar da sakamako na ƙarya;don haka, ana ba da shawarar horarwa a cikin tarin samfurori saboda mahimmancin ingancin samfurin don samun ingantaccen sakamakon gwaji.Nau'in samfurin da aka yarda da shi don gwaji shine samfurin swab na hanci kai tsaye da aka samo ta hanyar tattara nares biyu.Shirya bututun hakar bisa ga Tsarin Gwaji kuma yi amfani da swab maras kyau da aka bayar a cikin kit don tarin samfura.

Tarin Nasal Swab

1.Cire swab daga kunshin.

2.Kwantar da kan mara lafiya baya game da 70°.

3.1-2 Yayin da ake juya swab a hankali, saka swab kamar 2.5 cm (inch 1) cikin hanci har sai an gamu da juriya a turbinates.

4.Juyawa swab sau da yawa akan bangon hanci kuma a sake maimaita sauran hancin ta amfani da swab iri ɗaya.

Samfuran sufuri da Ajiye

Kada a mayar da swab zuwa ainihin marufi na swab.Ya kamata a sarrafa samfuran da aka tattara da wuri da wuri, amma ba a wuce sa'a ɗaya ba bayan tattara samfurin.

HANYAR GWADA

Lura:Bada kaset ɗin gwaji, reagents da samfurori don daidaitawa zuwa zafin jiki (15-30 ℃ ko 59-86 ℉) kafin gwaji.

1. Sanya bututun cirewa a cikin wurin aiki.

2.Peel kashe hatimin tsare-tsare na aluminum daga saman bututun cirewa wanda ke dauke da bututun cirewa wanda ke dauke da buffer cirewa.

3.Sampling yana nufin sashin 'Tarin Samfura'.

4.Saka samfurin swab na hanci a cikin bututun cirewa wanda ya ƙunshi reagent cirewa.Mirgine swab aƙalla sau 5 yayin danna kan ƙasa da gefen bututun cirewa.Bar swab na hanci a cikin bututun cirewa na minti daya.

5.Cire swab na hanci yayin da ake matse sassan bututu don cire ruwa daga swab.Za a yi amfani da maganin da aka fitar azaman samfurin gwaji.6.Rufe bututun hakar tare da titin digo sosai.

7.Cire kaset ɗin gwaji daga jakar da aka rufe.

8.Mayar da bututun hakar samfurin, riƙe bututun tsaye, canja wurin 3 saukad da (kimanin 100 μL) sannu a hankali zuwa samfurin da kyau (S) na kaset ɗin gwaji, sannan fara mai ƙidayar lokaci.

9. Jira Lines masu launin su bayyana.Fassara sakamakon gwajin a minti 15.Kar a karanta sakamakon bayan mintuna 20.

FASSARAR SAKAMAKO

C T

Layuka biyu sun bayyana.Layi mai launi ɗaya ya bayyana na ƙarfin layin gwaji.

Korau

Layi mai launi ɗaya yana bayyana a yankin sarrafawa (C), kuma babu layi da ya bayyana a yankin gwaji (T).

Ba daidai ba

C T

Sarrafa layi kasa to bayyana. Rashin isassun samfurin ƙira ko dabarun ƙa'ida ba daidai ba shine mafi kusantar dalilai na gazawar layin sarrafawa.Bita tsarin kuma maimaita gwajin ta amfani da sabon kaset na gwaji.Idan matsalar ta ci gaba, daina amfani da kuri'a nan da nan kuma tuntuɓi mai rarrabawa na gida.

KYAUTATA KYAUTA

An haɗa tsarin sarrafawa a cikin gwajin.Layi mai launi da ke bayyana a cikin yankin sarrafawa (C) ana ɗaukar tsarin kulawa na ciki.Yana tabbatar da isassun ƙarar samfuri, isassun wicking membrane da ingantaccen dabarar tsari.

Ba a samar da matakan sarrafawa tare da wannan kit ɗin.Koyaya, ana ba da shawarar cewa a gwada ingantattun sarrafawa da mara kyau azaman kyakkyawan aikin dakin gwaje-gwaje don tabbatar da tsarin gwajin da kuma tabbatar da aikin gwajin da ya dace.

IYAKA

• Samfurin yana iyakance don samar da gano inganci.Ƙarfin layin gwajin ba lallai ba ne ya dace da tattarawar antigen na samfuran.

Sakamako mara kyau baya hana kamuwa da cutar SARS-CoV-2 kuma idan alamun bayyanar cututtuka sun kasance dole ne ku nemi ƙarin gwaji nan da nan Ta Hanyar PCR.

Dole ne likita ya fassara sakamakon tare da tarihin mai haƙuri, binciken jiki, da sauran hanyoyin bincike.

•Ya kamata PCR ta tabbatar da mummunan sakamako da aka samu daga wannan Kit ɗin.Wani mummunan sakamako na iya faruwa idan adadin antigens SARS-CoV-2 da ke cikin samfurin ya kasance ƙasa da matakin ganowa na gwajin, ko kuma kwayar cutar ta sami ƙaramin maye gurbi (s) a cikin yankin epitope da aka gano ta hanyar rigakafin monoclonal. ana amfani da shi a cikin gwajin.

Yawan jini ko gamsai akan samfurin swab na iya tsoma baki tare da aiki kuma yana iya haifar da sakamako mai kyau na ƙarya.

HALAYEN YI

Ayyukan Clinical

COVID-19 antigen		RT-PCR		Jumla
COVID-19 antigen		M	Korau	Jumla
HEO®	M	212	0	212
HEO®	Korau	3	569	572
Jimlar		215	569	784

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

PPA - Yarjejeniyar Kashi Mai Kyau (Hankali) NPA - Yarjejeniyar Kashi Mara Kyau (Takamaimai) 95% *Takaitaccen Takaitaccen Aminci

Kwanaki tun da alama	RT-PCR	TECHNOLOGY	Yarjejeniya(%)
0-3	95	92	96.84%
4-7	120	120	100%

Darajar CT	RT-PCR	TECHNOLOGY	Yarjejeniya(%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
37	9	7	77.78%

Iyaka na Ganewa (Nazarin Nazari)

Binciken ya yi amfani da kwayar cutar SARS-CoV-2 mai al'ada, wacce ba ta kunna zafi kuma ta shiga cikin samfurin swab na hanci.Iyakar Ganewa (LoD) shine 1.0 ×102 TCID50/mL.

Reactivity (Tsarin Nazari)

An kimanta reactivity ta hanyar gwaji 32 commensal da pathogenic microorganisms waɗanda zasu iya kasancewa a cikin kogon hanci.Ba a lura da sake kunnawa ba tare da recombinant MERS-CoV NP protein lokacin da aka gwada shi a yawan 50 pg/mL.

Ba a lura da sake kunnawa tare da ƙwayoyin cuta masu zuwa ba lokacin da aka gwada su a matakin 1.0 × 106 PFU/ml: mura A (H1N1), mura A (H1N1pdm09), mura A (H7N9), mura A (H3N2), mura B ( Yamagata), mura B (Victoria), Adenovirus (nau'in 1, 2, 3, 5, 7, 55), Human metapneumovirus,

Kwayar cutar parainfluenza (nau'in 1, 2, 3, 4), kwayar cutar syncytial na numfashi, Enterovirus, Rhinovirus, coronavirus ɗan adam 229E, coronavirus ɗan adam OC43, coronavirus ɗan adam NL63, coronavirus ɗan adam HKU1.

Ba a lura da sake kunnawa tare da ƙwayoyin cuta masu zuwa ba lokacin da aka gwada su a matakin 1.0 × 107 CFU / mL: Mycoplasma pneumoniae, Chlamy-dia pneumoniae, Legionella pneumophila, Haemophilus mura, Streptococ-cus pyogenes (kungiyar A, Predidaumoniae). Albicans Staphylococcus aureus.

Tsangwama

Abubuwan da za a iya tsoma baki masu zuwa an kimanta su tare da COVID-19 Antigen Rapid Test Cassette (Nasal Swab) a cikin abubuwan da aka lissafa a ƙasa kuma an gano ba su da tasiri a aikin gwaji.

Abu	Hankali	Abu	Hankali
Mucin	2%	Jini duka	4%
Benzocaine	5 mg/ml	Menthol	10 mg/ml
Saline spray na hanci	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/ml
Tobramycin	5 μg/ml	Zanamivir	5 mg/ml
Oseltamivir phosphate	10 mg/ml	Ribavirin	5 mg/ml
Arbidol	5 mg/ml	Dexamethasone	5 mg/ml
Fluticasone propionate	5%	Histamine dihydrochloride	10 mg/ml
Triamcinolone	10 mg/ml	Histamine dihydrochloride	10 mg/ml

Tasirin ƙugiya mai girma

An gwada kaset ɗin gwajin sauri na Antigen Antigen (Colloidal Gold) har zuwa 1.0 × 10 5 TCID50 / ml na SARS-CoV-2 da ba a kunna ba kuma ba a sami tasirin ƙugiya mai girma ba.

Tambayar da ake yawan yi

1.Ta yaya SARS-CoV-2 Antigen Rapid Test ke aiki?Gwajin shine don gano ingantattun antigens na SARS-CoV-2 a cikin samfuran swab da suka tattara kansu.Kyakkyawan sakamako yana nuna antigens SARS-CoV-2 da ke cikin samfurin.

Yaushe ya kamata a yi amfani da gwajin?

Ana iya gano antigen SARS-CoV-2 a cikin ƙwayar cuta mai saurin kamuwa da cuta, ana ba da shawarar yin gwajin lokacin da alamun bayyanar cututtuka gami da farawar kwatsam na aƙalla ɗaya daga cikin masu zuwa: tari, zazzabi, ƙarancin numfashi, gajiya, raguwar ci, myalgia.

Shin sakamakon zai iya zama kuskure?

Sakamakon daidai ne idan an mutunta umarnin a hankali.Duk da haka, sakamakon zai iya zama ba daidai ba idan rashin isassun samfurin girma ko SARS-CoV-2 Antigen Rapid Test ya jika kafin yin gwajin, ko kuma idan adadin abubuwan cirewar cirewa bai wuce 3 ko fiye da 4. Bayan haka, saboda ƙa'idodin rigakafi. da hannu, akwai yuwuwar samun sakamako na ƙarya a lokuta da ba kasafai ba.Ana ba da shawarar yin shawarwari tare da likita koyaushe don irin waɗannan gwaje-gwaje bisa ka'idodin rigakafi.

Yadda za a fassara gwajin idan launi da ƙarfin layin sun bambanta?Launi da ƙarfin layin ba su da mahimmanci ga fassarar sakamako.Layukan ya kamata su kasance masu kama da juna kawai kuma a bayyane.Ya kamata a yi la'akari da gwajin a matsayin tabbatacce ko wane irin launi na layin gwajin ya kasance.5.Me zan yi idan sakamakon ya kasance mara kyau?

Sakamako mara kyau yana nufin cewa kun kasance mara kyau ko kuma cewa ƙwayar ƙwayar cuta ta yi ƙasa da ƙasa

don rashin saninsa ta hanyar gwajin.Koyaya, yana yiwuwa wannan gwajin ya ba da sakamako mara kyau wanda ba daidai ba (mara kyau na ƙarya) a wasu mutane masu COVID-19.Wannan yana nufin kuna iya har yanzu kuna da COVID-19 duk da cewa gwajin ba ya da kyau.

Idan kun fuskanci bayyanar cututtuka irin su ciwon kai, ciwon kai, zazzabi, asarar jin wari da dandano, tuntuɓi wurin likita mafi kusa ta amfani da dokokin yankin ku.Bugu da kari, zaku iya maimaita gwajin tare da sabon kayan gwaji.Idan akwai tuhuma, maimaita gwajin bayan kwanaki 1-2, saboda ba za a iya gano ainihin coronavirus a duk matakan kamuwa da cuta ba.Dole ne har yanzu a kiyaye dokokin nesa da tsabta.Ko da tare da mummunan sakamakon gwaji, dole ne a kiyaye nesa da ƙa'idodin tsabta, ƙaura/tafiya, halartar abubuwan da suka faru da sauransu. yakamata su bi jagororin/bukatun COVID na gida.6.Me zan yi idan sakamakon ya tabbata?

Kyakkyawan sakamako yana nufin kasancewar SARS-CoV-2 antigens.Kyakkyawan sakamako yana nufin yana da yuwuwar kuna da COVID-19.Nan da nan shiga cikin keɓe kai daidai da ƙa'idodin gida kuma nan da nan tuntuɓi babban likita / likitan ku ko sashen kiwon lafiya na gida bisa ga umarnin hukumomin yankin ku.Za a duba sakamakon gwajin ku ta hanyar gwajin tabbatar da PCR kuma za a bayyana muku matakai na gaba.