COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)
[YADDA AKE NUFI]
COVID-19 Antigen Rapid Cassette (Saliva) immunoassay ne mai gudana na gefe wanda aka yi niyya don gano ƙimar SARS-CoV-2 nucleocapsid antigens a cikin salwa daga mutanen da ake zargin COVID-19 ta hanyar masu ba da kiwon lafiya.
Sakamako shine don gano SARS-CoV-2 nucleocapsid antigen.Ana iya gano antigen gabaɗaya a cikin ɗigon ruwa a lokacin tsananin 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.
An yi nufin kaset ɗin gwajin gaggawa na Antigen na COVID-19 (Saliva) don amfani da kwararrun likitoci ko kwararrun ma'aikata waɗanda suka ƙware wajen yin gwaje-gwajen kwarara ta gefe.Ana iya amfani da samfurin a kowane dakin gwaje-gwaje da mahalli mara dakin gwaje-gwaje wanda ya dace da buƙatun da aka ƙayyade a cikin Umarnin amfani da ƙa'idodin gida.
[TAKATAI]
Novel coronaviruses (SARS-CoV-2) na cikin nau'in p.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]
Kasset ɗin Gwajin Saurin Antigen na COVID-19 (Saliva) rigakafi ne mai gudana ta gefe bisa ƙa'idar dabarar sanwici mai rigakafin mutum biyu.SARS-CoV-2 nucleocapsid protein monoclonal antibody hade tare da microparticles launi ana amfani dashi azaman mai 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.
[GARGAƊI DA KIYAYE]
• Don in vitro diagnostic amfani kawai.
• Don ƙwararrun kiwon lafiya da waɗanda aka horar da su a fagen saitunan kulawa.
•Kada kayi amfani da wannan samfurin azaman tushen kawai don tantancewa ko ware
Cutar SARS-CoV-2 ko don sanar da yanayin kamuwa da cuta na COVID-19.
•Kada kayi amfani da wannan samfurin bayan ranar karewa.
Da fatan za a karanta duk bayanan da ke cikin wannan takarda kafin yin gwajin.
•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 watsi da kaset ɗin gwajin da aka yi amfani da shi bisa ga dokokin tarayya, jihohi da na gida.
[HAUKI]
An Samar da Kayayyakin
• Gwada Cassettes: kowane kaset tare da desiccant a cikin jakar foil guda ɗaya
• Reagents Extraction: ampoule dauke da 0.3 ml na reagent hakar
•Masu Tari
•Tarin bututu
•Masu saukarwa
• Saka Kunshin
Kayayyakin da ake buƙata amma ba a ba su ba
• Mai ƙidayar lokaci
[AJIYA DA KWANTAWA]
• Ajiye kamar yadda aka shirya a cikin jakar da aka rufe a zazzabi (4-30°C ko 40-86T).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.
An buga LOT da ranar karewa akan lakabin.
[TARIN MUSAMMAN DA SHIRI]
KAR KA sanya wani abu a baki ciki har da abinci, abin sha, danko ko kayan taba na akalla mintuna 30 kafin tarin.
Yi amfani da bututun tarawa da mai tari don tattara miya.Saka mai tara ruwan yau a cikin bututun tarawa, sannan a sanya mai tari kusa da lebe sannan a bar ruwan ya kwarara cikin bututun tarin.Ƙararren ɗigon ruwa yana buƙatar zama a ma'auni (kimanin.300|jL).Idan ƙarar gishiri ya yi yawa, yi amfani da dropper don cire abin da ya wuce har sai bayani na ƙarshe a ma'auni (kimanin 300pL).[YADDA AKE NUFI]
COVID-19 Antigen Rapid Cassette (Saliva) immunoassay ne mai gudana na gefe wanda aka yi niyya don gano ƙimar SARS-CoV-2 nucleocapsid antigens a cikin salwa daga mutanen da ake zargin COVID-19 ta hanyar masu ba da kiwon lafiya.
Sakamako shine don gano SARS-CoV-2 nucleocapsid antigen.Ana iya gano antigen gabaɗaya a cikin ɗigon ruwa a lokacin tsananin 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.
An yi nufin kaset ɗin gwajin gaggawa na Antigen na COVID-19 (Saliva) don amfani da kwararrun likitoci ko kwararrun ma'aikata waɗanda suka ƙware wajen yin gwaje-gwajen kwarara ta gefe.Ana iya amfani da samfurin a kowane dakin gwaje-gwaje da mahalli mara dakin gwaje-gwaje wanda ya dace da buƙatun da aka ƙayyade a cikin Umarnin amfani da ƙa'idodin gida.
[TAKATAI]
Novel coronaviruses (SARS-CoV-2) na cikin nau'in p.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]
Kasset ɗin Gwajin Saurin Antigen na COVID-19 (Saliva) rigakafi ne mai gudana ta gefe bisa ƙa'idar dabarar sanwici mai rigakafin mutum biyu.SARS-CoV-2 nucleocapsid protein monoclonal antibody hade tare da microparticles launi ana amfani dashi azaman mai 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.
[GARGAƊI DA KIYAYE]
• Don in vitro diagnostic amfani kawai.
• Don ƙwararrun kiwon lafiya da waɗanda aka horar da su a fagen saitunan kulawa.
•Kada kayi amfani da wannan samfurin azaman tushen kawai don tantancewa ko ware
Cutar SARS-CoV-2 ko don sanar da yanayin kamuwa da cuta na COVID-19.
•Kada kayi amfani da wannan samfurin bayan ranar karewa.
Da fatan za a karanta duk bayanan da ke cikin wannan takarda kafin yin gwajin.
•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 watsi da kaset ɗin gwajin da aka yi amfani da shi bisa ga dokokin tarayya, jihohi da na gida.
[HAUKI]
An Samar da Kayayyakin
• Gwada Cassettes: kowane kaset tare da desiccant a cikin jakar foil guda ɗaya
• Reagents Extraction: ampoule dauke da 0.3 ml na reagent hakar
•Masu Tari
•Tarin bututu
•Masu saukarwa
• Saka Kunshin
Kayayyakin da ake buƙata amma ba a ba su ba
• Mai ƙidayar lokaci
[AJIYA DA KWANTAWA]
• Ajiye kamar yadda aka shirya a cikin jakar da aka rufe a zazzabi (4-30°C ko 40-86T).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.
An buga LOT da ranar karewa akan lakabin.
[TARIN MUSAMMAN DA SHIRI]
KAR KA sanya wani abu a baki ciki har da abinci, abin sha, danko ko kayan taba na akalla mintuna 30 kafin tarin.
Yi amfani da bututun tarawa da mai tari don tattara miya.Saka mai tara ruwan yau a cikin bututun tarawa, sannan a sanya mai tari kusa da lebe sannan a bar ruwan ya kwarara cikin bututun tarin.Ƙararren ɗigon ruwa yana buƙatar zama a ma'auni (kimanin.300|jL).Idan ƙarar gishiri ya yi yawa, yi amfani da dropper don cire abin da ya wuce har sai bayani na ƙarshe a ma'auni (kimanin 300pL).
Samfuran sufuri da Ajiye
Ya kamata a sarrafa samfuran da aka tattara da wuri da wuri, amma ba a wuce sa'a ɗaya ba bayan tattara samfurin.
[TSARAR GWAJI]
Lura: Bada kaset ɗin gwajin, reagents da samfurori don daidaitawa zuwa zafin jiki (15-30°C ko 59-86T) kafin gwaji.
Sanya bututun tarawa tare da mai tara miya wanda ke da miya a tashar aiki.Cire murfin abin da ake cirewa.Ƙara duk reagents masu cirewa cikin bututun tarin.
A jefar da mai tari;Rufe bututun tarin tare da titin digo akan bututun tarin.Ki girgiza bututun da aka tara fiye da sau uku da karfi don hada miya da abin da ake cirewa, sannan a matse maganin da aka gauraya har sau goma domin bada damar gauraye sosai.
Cire kaset ɗin gwajin daga jakar da aka rufe.
Juya bututun tarin, riƙe bututun a tsaye, canja wurin ɗigo 3 (kimanin 100pL) sannu a hankali zuwa samfurin da kyau (S) na kaset ɗin gwaji, sannan fara mai ƙidayar lokaci.
Jira layin masu launi su bayyana.Fassara sakamakon gwajin a minti 15.Kar a karanta sakamakon bayan mintuna 20.
| [FASARAR SAKAMAKO] | |||
| Mai kyau | | § | Layuka biyu sun bayyana.Ɗayan layi mai launi yana bayyana H c a yankin sarrafawa (C), da kuma wani Jt|jne yana bayyana a yankin gwaji (T), ba tare da la'akari da ƙarfin layin gwajin ba. | |
| Korau | Layi mai launi ɗaya yana bayyana a yankin sarrafawa (C), kuma babu layi da ya bayyana a yankin gwaji (T). | ||
| Ba daidai ba | Layin sarrafawa ya kasa bayyana.Rashin isa,ƙarar samfurin ko dabarar tsari 5 da ba daidai ba shine mafi kusantar dalilai na gazawar layin sarrafa c.Yi nazarin tsarin kuma Jtmaimaita gwajin ta amfani da sabon kaset na gwaji.IdanJ)matsalar ta ci gaba, daina amfani da kuri'a nan da nan kuma tuntuɓi mai rarrabawa na gida. | ||
[KAMAKIYAR 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 a matsayin kyakkyawan aikin dakin gwaje-gwaje don tabbatar da aikin gwajin da kuma tabbatar da aikin gwajin da ya dace.
[LIMITATIONS]
An iyakance samfurin 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 bai kamata a yi amfani da shi azaman tushen kawai don yanke shawarar sarrafa haƙuri ba.
Dole ne likita ya fassara sakamakon tare da tarihin mai haƙuri, binciken jiki, da sauran hanyoyin bincike.
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.
[Halayen Aiki]
Ayyukan Clinical
Aikin asibiti na COVID-19 Antigen Rapid Test Cassette (Saliva) an kafa shi a cikin bincike mai zuwa tare da samfuran da aka tattara daga marasa lafiya na 628 (a cikin kwanaki 7 na farawa) da marasa lafiya asymptomatic waɗanda ake zargi da COVID-19.
Takaitattun bayanai na COVID-19 Antigen Rapid Test kamar ƙasa:
Ƙofar sake zagayowar RT-PCR (Ct) ita ce ƙimar siginar da ta dace.Ƙimar Ct ƙasa tana nuna mafi girman nauyin hoto.An ƙididdige hankali don kewayon ƙimar Ct daban-daban (Ct valueW37)
| Cutar COVID-19 | RT-PCR | Jimlar | ||
| Positivo | Negativo | |||
| HEO® | Positivo | 172 | 0 | 172 |
| Negativo | 3 | 453 | 456 | |
| Jimlar | 175 | 453 | 628 | |
Yarjejeniyar Kashi Mai Kyau (PPA)=98.28%(172/175),(95%CI:95.08%~99.41%)
Yarjejeniyar Kashi Mara Kyau(NPA)=100%(453/453),(95%CI:99.15%~100%)
PPA - Yarjejeniyar Kashi Mai Kyau (Hankali)
NPA - Yarjejeniyar Kashi Mara Kyau (Takamaiman)
Iyaka na Ganewa (Nazarin Nazari)
Binciken ya yi amfani da ƙwayar cuta ta SARS-CoV-2 (Ware Hong Kong / VM20001061/2020, NR-52282), wanda zafi baya kunnawa kuma ya zuga cikin yau.Iyakar Ganewa (LoD) shine 8.6 X102TCIDso/ml.
Reactivity (Tsarin Nazari)
An kimanta reactivity ta hanyar gwaji 32 commensal da pathogenic microorganisms waɗanda zasu iya kasancewa a cikin baka.
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 1.0x106PFU/ml: mura A (H1N1), mura A
(H1N1 pdm09), mura A(H3N2), mura B (Yamagata), mura B (Victoria), Adenovirus (nau'in 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza cutar (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 ba tare da ƙwayoyin cuta masu zuwa lokacin da aka gwada su a cikin 1.0x10' CFU / mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, Haemophilus mura, Streptococcus pyogenes (kungiyar A), Streptococcus pyogenes (kungiyar A), Streptoubicccus pneumoniae. aureus.
Tsangwama
Abubuwan da za a iya tsoma baki masu zuwa an kimanta su tare da COVID-19 Antigen Rapid Test Cassette (Saliva) a cikin abubuwan da aka lissafa a ƙasa kuma an same su ba su shafar aikin tegt.
| 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% | Histamine dihydrochloride | 10 mg/ml |
| Tobramycin | 5 pg/ml | Mupirocin | 10 mg/ml |
| Oseltamivir phosphate | 10 mg/ml | Zanamivir | 5 mg/ml |
| Arbidol | 5 mg/ml | Ribavirin | 5 mg/ml |
| Fluticasone propionate | 5% | Dexamethasone | 5 mg/ml |
| Triamcinolone | 10 mg/ml |
Tasirin ƙugiya mai girma
An gwada kaset ɗin gwajin sauri na Antigen Antigen (Saliva) har zuwa 1.15x1 o' TCIDso/mL na SARS-CoV-2 da ba a kunna ba kuma ba a sami tasirin ƙugiya mai girma ba.
Hangzhou Heo Technology Co.,Ltd.
Adireshin: Room201, Ginin 3, No.2073 Hanyar Jinchang,
Titin Liangzhu, gundumar Yuhang, Hangzhou, lambar akwatin gidan China: 311113
Tel: 0086-571-87352763 Imel:52558565@qq.com
Lotus NL BV Adireshin: Koningin Julianaplein 10, le Verd,
2595AA, Hague, Netherlands.Imel:Peter@lotusnl.com
Lambar waya:+31644168999
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
| M | C T | C T | Layuka biyu sun bayyana.Layi mai launi ɗaya ya bayyana na ƙarfin layin gwaji. |
| Korau | CT | 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 | CT | 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
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.
| COVID-19 antigen | RT-PCR | Jumla | ||
| M | Korau | |||
| HEO® | M | 212 | 0 | 212 |
| 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 |
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.
BIBLIOGRAFIE
Weiss SR, Leibowitz JZ.Cutar cututtuka na Coronavirus, Adv Virus Res 2011;81:85-164
Kui J, li F, Shi ZL.Asalin da juyin halittar ƙwayoyin cuta na ƙwayoyin cuta.Nat Rev Microbiol 2019;17:181-192
Su S, Wong G, Shi W, et al.Epidemiology, sake hadewar kwayoyin halitta, da cututtukan cututtukan coronavirues.TrendsMicrobiol 2016;24:4900502.
BAYANIN ALAMOMIN
