QUIDEL QuickVue SARS Antigen Test Manual

Gwajin QuickVue SARS Antigen gwajin rigakafi ne na gefe wanda ke ba da damar saurin gano ƙimar furotin na nucleocapsid daga SARS-CoV-2 a cikin samfuran swab na baya (NS) kai tsaye daga mutanen da ake zargin COVID-19 ta hanyar kiwon lafiya. mai badawa a cikin kwanaki biyar na farkon bayyanar cututtuka. Gwaji yana iyakance ga dakunan gwaje-gwajen da aka ba da izini a ƙarƙashin gyare-gyaren gyare-gyare na Laboratory Clinical na 1988 (CLIA), 42 USC §263a, waɗanda suka cika buƙatun don yin matsakaici, babba, ko gwajin rikitarwa. An ba da izinin wannan gwajin don amfani a wurin Kulawa (POC), watau, saitunan kula da marasa lafiya waɗanda ke aiki ƙarƙashin Takaddun Shaida ta CLIA, Takaddun Yarda, ko Takaddun Takaddun Shaida. Gwajin QuickVue SARS Antigen ba ya bambanta tsakanin SARS-CoV da SARS-CoV-2. Sakamako shine don gano SARS-CoV-2 nucleocapsid protein antigen. Ana iya gano antigen gabaɗaya a cikin samfuran nares na baya yayin babban lokacin kamuwa da cuta. Sakamakon sakamako mai kyau yana nuna kasancewar antigens na hoto ko bidiyo mai zagaya yanar gizo da sauri, amma alaƙar 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. Ana buƙatar dakunan gwaje-gwaje a cikin Amurka da yankunanta su kai rahoton duk sakamakon ga hukumomin kiwon lafiyar jama'a da suka dace. Ya kamata a yi la'akari da sakamakon da ba daidai ba a matsayin zato da kuma tabbatarwa tare da nazarin kwayoyin halitta, idan ya cancanta, don gudanar da haƙuri, za a iya yi. Sakamako mara kyau baya kawar da COVID-19 kuma bai kamata a yi amfani da shi azaman tushen kawai don jiyya 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 alamun da suka yi daidai da COVID-19. Ana yin gwajin gwajin Antigen na QuickVue SARS don amfani da kwararrun ma'aikatan dakin gwaje-gwaje na asibiti da kuma daidaikun wadanda aka horar da su a fagen saitunan kulawa. Gwajin Antigen na QuickVue SARS don amfani ne kawai a ƙarƙashin Izinin Amfani da Gaggawa na Hukumar Abinci da Magunguna.

TAKAITACCE DA BAYANI

SARS-CoV-2, wanda aka fi sani da COVID-19, an fara gano shi a Wuhan, lardin Hubei, na kasar Sin a watan Disamba 2019. Wannan kwayar cutar, kamar ta sabon coronavirus SARS-1 da MERS, ana tsammanin ta samo asali ne daga jemagu. , duk da haka, SARS-CoV-2 na iya samun mai shiga tsakani kamar su pangolins, da alade, ko civets.1 WHO ta bayyana cewa COVID-19 annoba ce a ranar 11 ga Maris, 2020, kuma kamuwa da cutar ɗan adam ya yadu a duniya, tare da daruruwan dubban da aka tabbatar sun kamu da cutar da kuma mace-mace.2 An kiyasta lokacin kamuwa da cutar ya kai kwanaki 5.1 tare da alamun alamun da ake sa ran za su kasance a cikin kwanaki 12 na kamuwa da cuta.3 Alamomin COVID-19 suna kama da sauran cututtukan numfashi na viral kuma sun haɗa da zazzabi, tari, da karancin numfashi.4

KA'IDAR HANYA

Gwajin Antigen na QuickVue SARS yana amfani da fasahar rigakafin rigakafi ta gefe. Amfani da wannan gwajin yana ba da damar gano saurin gano furotin nucleocapsid daga SARS-CoV da SARS-CoV-2. Wannan gwajin yana ba da damar gano SARS-CoV da SARS-CoV-2 amma baya bambanta tsakanin ƙwayoyin cuta guda biyu.
Don fara gwajin, dole ne a sake sanya reagent mai lyophilized a cikin Tube Reagent. Wannan reagent yana sauƙaƙe fallasa ingantattun antigens na hoto ko bidiyo mai zagaya yanar gizo da sauri zuwa ƙwayoyin rigakafin da aka yi amfani da su a cikin gwajin. An fara maido da Reagent tare da samar da Maganin Reagent, sannan ana saka samfurin swab a cikin Tube Reagent. Wannan Reagent yana hulɗa tare da samfurin kuma yana sauƙaƙe bayyanar da antigens da suka dace ga ƙwayoyin rigakafi da aka yi amfani da su a gwajin. Ana ƙara Strip ɗin Gwajin zuwa Reagent Tube yanzu yana ɗauke da samfurin da Maganin Reagent.
Idan samfurin da aka fitar ya ƙunshi SARS-CoV ko SARS-CoV-2 antigens, Layin Gwajin ruwan hoda-zuwa-ja, tare da layin Sarrafa shuɗi mai shuɗi zai bayyana akan Tashin Gwajin yana nuna kyakkyawan sakamako. Idan SARS-CoV ko SARS-CoV-2 ba su nan ko kuma suna nan a cikin ƙananan matakan, layin Sarrafa shuɗi ne kawai zai bayyana.

REAgents DA KAYAN DA AKA BAYAR

25-Kitin Gwaji

Fakitin Gwajin Kai-da-kai (25): Kwayoyin rigakafin SARS na Monoclonal
Reagent Tubes (25): Lyophilized buffer tare da detergents da rage wakilai

Maganin Reagent (25): Vials tare da maganin gishiri na 340 μL
Bakararre hanci Swabs (Kit #20387) (25)

Sarrafa Kyakkyawan Sarrafa Sarrafa Swab (1): Ana lulluɓe swab tare da antigens na SARS mara kamuwa da cuta.
Negative Control Swab (1): Ana lulluɓe swab tare da zafin-inactivated, antigen Streptococcus C mai cutarwa.

Kunshin Saka (1)
Katin aiwatarwa (1)

KAYAN BABU

Mai ƙidayar lokaci ko kallo

QuickVue SARS Antigen Control Swab Saita don ƙarin QC (20389)
Busashen jigilar kaya (SKU # 20385) (25). Ajiye a zafin jiki.

GARGADI DA TSIRA

Don amfanin in vitro diagnostic amfani
Don takardar sayan amfani kawai

Wannan samfurin ba a share ko yarda da FDA ba; amma FDA ta ba da izini a ƙarƙashin Izinin Amfani da Gaggawa (EUA) don amfani da dakunan gwaje-gwaje da aka tabbatar a ƙarƙashin CLIA waɗanda suka cika buƙatun don yin matsakaici, babba, ko gwajin rikitarwa. An ba da izinin wannan samfurin don amfani a wurin Kulawa (POC), watau, saitunan kula da marasa lafiya da ke aiki ƙarƙashin Takaddun Shaida ta CLIA, Takaddar Yarda, ko Takaddun Takaddun Shaida.
An ba da izinin wannan samfurin kawai don ganowar sunadarai daga SARS-CoV-2, ba don kowane ƙwayoyin cuta ko ƙwayoyin cuta ba.

An ba da izinin wannan gwajin kawai na tsawon lokacin sanarwar cewa yanayi ya wanzu yana ba da izinin yin amfani da gaggawa na gwaje-gwajen bincike na in vitro don ganowa da/ko gano cutar COVID-19 a ƙarƙashin Sashe na 564(b)(1) na Dokar, 21 USC § 360bbb-3(b)(1) sai dai idan ba a soke izini ko soke ba da wuri.
Kada ayi amfani da kayan aikin kit fiye da ranar ƙarewar da aka buga a gefen akwatin.

Sanya tufafin kariya masu dacewa, safar hannu (nitrile ko latex), da kariya ta ido/ fuska lokacin da ake sarrafa s.amples ko kayan aikin kit da aka yi amfani da su.
Maganin Reagent ya ƙunshi maganin gishiri (saline). Idan maganin yana hulɗa da fata ko ido, zubar da ruwa mai yawa.

Kada a sake amfani da Tushen Gwajin da aka yi amfani da shi, Reagent Tubes, mafita, ko Swabs Sarrafa.
Titin Gwajin dole ne ya kasance a rufe a cikin jaka mai kariya har sai an yi amfani da shi. Kada mai amfani ya taɓa buɗe jakar jakar gwajin gwajin da ke fallasa shi zuwa yanayin yanayi har sai an shirya Filin Gwajin don amfani nan take. Idan filin gwajin ya buɗe na awa ɗaya ko ya fi tsayi, sakamakon gwajin mara inganci na iya faruwa.

Dole ne a yi amfani da gwajin Antigen na QuickVue SARS tare da buffer lyophilized da maganin reagent da aka bayar a cikin kit ɗin.
Tarin samfurin da ya dace, ajiya, da sufuri suna da mahimmanci ga aikin wannan gwajin. Nemi horo na musamman ko jagora idan ba ku da kwarewa tare da tarin samfurori da hanyoyin sarrafawa.5,6,7,8

Lokacin tattara swab na hanci sample, yi amfani da swab ɗin hanci da aka bayar a cikin kayan (Kit #20387)
Rashin isassun samfuri ko rashin dacewa tara, ajiya, da sufuri na iya haifar da sakamako mara kyau na ƙarya.
Don samun ingantaccen sakamako, dole ne ku bi umarnin Saka Kunshin.
Mutanen da ke da hangen nesa mai launin launi ba za su iya iya fassarar sakamakon gwaji daidai ba.
Yakamata a yi gwaji a wuri mai isassun iska.
Zubar da kwantena da abubuwan da ba a yi amfani da su ba daidai da bukatun tarayya, Jiha, da na gida.
A wanke hannaye sosai bayan mu'amala.
Don ƙarin bayani kan aminci, sarrafawa, da zubar da abubuwan da ke cikin wannan kit ɗin, da fatan za a koma zuwa Takardun Bayanan Tsaro (SDS) dake quidel.com.

RUFE KITA DA KYAUTA

Ajiye kayan a zafin jiki, 59°F zuwa 86°F (15°C zuwa 30°C), daga hasken rana kai tsaye. Abubuwan da ke cikin Kit ɗin sun tsaya tsayin daka har sai an buga ranar karewa akan akwatin waje. Kar a daskare.
TATTARAWA DA SAMUN LAMARI NA MUSAMMAN
Tarin samfurin da ya dace da kulawa yana da mahimmanci ga aikin wannan gwajin.5,6,7,8 Tarin Samfurin Nasal Swab Sample
Yi amfani da swab ɗin hanci da aka kawo a cikin kayan.
Kafin tattara swab na hanci, ya kamata a umurci mara lafiya ya busa hanci. Don tattara hanci swab sampLe, saka gaba dayan titin swab (yawanci ½ zuwa ¾ na inci (1 zuwa 1.5 cm) a cikin hanci kuma da tabbaci s.ample da bangon hanci ta hanyar jujjuya swab a cikin madauwari hanya zuwa bangon hanci aƙalla sau 4. Ɗauki kusan daƙiƙa 15 don tattara sample. Tabbatar tattara duk wani magudanar hanci wanda zai iya kasancewa akan swab.
Sample da hancin hancin guda biyu.
SampSu Transport da Adana SampLes yakamata a gwada da wuri-wuri bayan tattarawa. Dangane da bayanan da aka ƙirƙira tare da Gwajin Antigen SARS na QuickVue, swabs na hanci yana da ƙarfi har zuwa awanni 120 a zafin ɗaki ko 2° zuwa 8°C a cikin busasshiyar bututun jigilar kaya.

KYAUTATA KYAUTA

Akwai nau'ikan Sarrafa Inganci na farko guda biyu don wannan na'urar: ginannen fasalulluka na sarrafawa da aka ayyana a ƙasa da sarrafawar waje.

Gina-in Sarrafa Features

Gwajin Antigen QuickVue SARS ya ƙunshi ginanniyar fasalulluka sarrafa tsari. Shawarar masana'anta don sarrafa yau da kullun ita ce rubuta waɗannan ingantattun abubuwan sarrafa tsarin na farkon sample gwada kowace rana.
Tsarin sakamako mai launi biyu yana ba da fassarar sauƙi na sakamako mai kyau da mara kyau. Bayyanar layin Sarrafa shuɗi yana ba da ingantaccen iko ta hanyar nuna isassun kwarara ya faru kuma an kiyaye amincin aikin Tashar Gwajin. Idan layin Sarrafa shuɗi ba ya haɓaka cikin mintuna 10 akan Tashar Gwajin, to sakamakon gwajin ba shi da inganci.
An samar da ingantacciyar kulawa mara kyau ta hanyar share launin ja, yana tabbatar da cewa an yi gwajin daidai. A cikin mintuna 10, yankin sakamakon yakamata ya zama fari zuwa ruwan hoda mai haske kuma ya ba da damar fayyace madaidaicin sakamakon gwajin. Idan launin bango ya kasance kuma yana yin katsalandan ga fassarar sakamakon gwajin, to sakamakon gwajin ba shi da inganci. Idan wannan ya faru, sakeview hanya da maimaita gwajin tare da sabon mai haƙuri sample da sabon Gwajin gwaji. Wajibi ne a tattara wani samfurin marasa lafiya; Ba za a iya sake amfani da swabs na haƙuri ko reagents ba.

Ikon Kyau na waje

Hakanan za'a iya amfani da Gudanarwar waje don nuna cewa reagents da tsarin tantancewa suna aiki da kyau.
Quidel yana ba da shawarar cewa a gudanar da sarrafawa masu inganci da mara kyau sau ɗaya ga kowane ma'aikacin da ba a horar da shi ba, sau ɗaya don kowane sabon jigilar kaya - muddin an gwada kowane nau'i daban-daban da aka karɓa a cikin jigilar kaya - kuma kamar yadda ake la'akari da hakan ya zama dole ta hanyoyin sarrafa ingancin cikin ku, kuma daidai. tare da ƙa'idodin gida, jihohi da tarayya ko buƙatun izini.
Ya kamata a yi amfani da Tsarin Gwajin da aka kwatanta a cikin Kunshin Saƙon lokacin da ake gwada abubuwan sarrafawa na waje.
Idan masu sarrafa ba su yi kamar yadda ake tsammani ba, maimaita gwajin ko tuntuɓi Taimakon Fasaha na Quidel kafin gwada samfuran haƙuri.
Ana iya samun ƙarin Swabs na Sarrafa daban ta tuntuɓar Sabis na Tallafin Abokin Ciniki na Quidel a (800) 874.1517 (kyauta a Amurka) ko (858) 552.1100.

HANYAR GWADA

Dole ne kayan gwaji da samfuran asibiti su kasance a cikin zafin jiki kafin fara gwajin.
Ranar karewa: Bincika ƙarewar kowane fakitin gwaji ko akwatin waje kafin amfani. Kada kayi amfani da kowane gwaji da ya wuce ranar karewa akan alamar.

Tsarin Gwajin Swab Nasal

Ƙara Maganin Reagent zuwa Reagent Tube. A hankali a juya bututun don narkar da abinda ke ciki.
Reagent Tube yakamata ya kasance a cikin mariƙin bututu don ɗaukacin gwajin.

Nan da nan sanya mara lafiya swab sampshiga cikin Reagent Tube. Mirgine swab aƙalla sau uku (3) yayin danna kan ƙasa da gefen Tube Reagent.
Ajiye swab a cikin bututu na minti daya (1).
Sakamakon kuskure ko mara inganci na iya faruwa idan lokacin shiryawa ya yi gajere ko tsayi sosai.

Bayyana duk ruwa daga kan swab ta hanyar mirgina swab aƙalla sau uku (3) yayin da ake cire swab. Yi watsi da swab daidai da ka'idar zubar da sharar halittu.
Sanya Tushen Gwajin cikin Reagent Tube tare da kibiyoyi suna nuna ƙasa. Kar a rike ko matsar da Filin Gwajin har sai an gama gwajin kuma a shirye don karantawa.
A minti goma (10), cire Tarin Gwajin, kuma karanta sakamakon a cikin mintuna biyar (5) bisa ga sashin fassarar sakamako.
Ya kamata a karanta sassan gwajin tsakanin mintuna 10 zuwa 15 bayan sanyawa cikin Tube Reagent. Sakamakon karya-tabbatacce, arya mara kyau, ko sakamako mara inganci na iya faruwa idan an karanta tsiri fiye da lokacin da aka tsara.

FASSARAR SAKAMAKO

Sakamako Mai Kyau*:
A cikin mintuna goma (10), bayyanar KOWANE inuwa na Layin Gwajin ruwan hoda-zuwa-ja DA bayyanar layin Sarrafa shuɗi yana nuna kyakkyawan sakamako na kasancewar SARS antigen. Sakamako za su kasance barga na tsawon mintuna biyar (5) bayan shawarar lokacin karantawa. Kar a karanta sakamakon sama da mintuna goma sha biyar bayan sanya shi cikin Reagent Tube.

*Sakamako mai kyau ba zai kawar da kamuwa da cuta tare da sauran ƙwayoyin cuta ba.
∗Duba da kyau! Wannan sakamako ne mai kyau. Ko da kun ga Layin Gwajin ruwan hoda mai suma da shuɗi, dole ne ku bayar da rahoton sakamakon a matsayin KYAU.
C = Layin Sarrafa

T = Layin Gwaji

Sakamako mara kyau**:

A cikin mintuna goma (10), bayyanar KAWAI Layin Sarrafa shuɗi yana nuna ba a gano antigen na SARS ba. Sakamako za su kasance barga na tsawon mintuna biyar (5) bayan shawarar lokacin karantawa. Kar a karanta sakamakon sama da mintuna goma sha biyar bayan sanya shi cikin Reagent Tube.
**Sakamako mara kyau baya ware kamuwa da cutar SARS-CoV-2. Ya kamata a kula da sakamakon da ba daidai ba a matsayin abin zato kuma yana iya buƙatar tabbatarwa tare da tantancewar kwayoyin halitta.

Sakamako mara aiki

Idan a minti goma (10), layin Sarrafa shuɗi ba ya bayyana, ko da wata inuwa ta Layin Gwajin ruwan hoda zuwa ja ya bayyana, sakamakon ba ya aiki.
Idan a minti goma (10) launi na baya baya sharewa kuma yana yin tsangwama ga karatun gwajin, sakamakon shima ba shi da inganci.

Idan sakamakon bai inganta ba, yakamata a yi sabon gwaji tare da sabon majiyyaci sample da sabon Gwajin gwaji.

IYAKA

Anyi nufin gwajin don samfuran swab kai tsaye kawai. Kada a yi amfani da Media Transport Media (VTM) tare da wannan gwajin saboda yana iya haifar da sakamakon karya.

Abubuwan da ke cikin wannan kit ɗin za a yi amfani da su ne kawai don gano ƙwararrun antigens na SARS daga samfuran swab na hanci na gaba.
Sakamakon gwaji mara kyau na iya faruwa idan matakin antigen a cikin asample yana ƙasa da iyakar gano gwajin ko kuma idan sample aka tattara ba daidai ba.
Wannan gwajin yana gano duka mai yuwuwa (mai rai) da wanda ba zai yiwu ba, SARS-CoV, da SARS-CoV-2. Ayyukan gwajin ya dogara da adadin ƙwayar cuta (antigen) a cikin sample kuma yana iya ko a'a ya daidaita da sakamakon al'adun hoto da aka yi akan s iri ɗayaample.

Rashin bin Tsarin Gwajin da Fassarar Sakamako na iya yin illa ga aikin gwajin da/ko ɓata sakamakon gwajin.
Dole ne a kimanta Sakamakon Gwaji tare da sauran bayanan asibiti da ke akwai ga likita.
Sakamakon gwajin mara kyau ba ana nufin yin mulki a cikin wasu cututtukan ƙwayoyin cuta da ba na SARS ba.

Sakamakon gwaji mai kyau ba zai kawar da kamuwa da cuta tare da wasu ƙwayoyin cuta ba.
Ya kamata a yi la'akari da sakamakon da ba daidai ba a matsayin zato, kuma tabbatarwa tare da ƙididdigar kwayoyin halitta, idan ya cancanta don kulawa da haƙuri, za a iya yi.
Idan ana buƙatar bambance-bambancen takamaiman ƙwayoyin cuta na SARS da ƙwayoyin cuta, ana buƙatar ƙarin gwaji, tare da tuntuɓar sassan kiwon lafiya na jihohi ko na gida.

Sharuɗɗan izni ga ɗakin dakunan gwaje-gwaje da saitunan kula da marasa lafiya.

Wasikar Izini ta QuickVue SARS Antigen Gwajin, tare da Haƙƙin Takaddar Gaskiya don Masu Ba da Kiwon Lafiya, Takaddar Gaskiyar Izini don Marasa lafiya, da alamar izini suna samuwa akan FDA webYanar Gizo: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
Koyaya, don taimakawa dakunan gwaje-gwaje na asibiti ta amfani da gwajin Antigen na QuickVue SARS (“samfurin ku” a cikin yanayin da ke ƙasa), an jera Sharuɗɗan izini masu dacewa a ƙasa:

Dakunan gwaje-gwaje masu izini* masu amfani da samfurin ku dole ne su haɗa da rahoton sakamakon gwaji, da duk takaddun shaida masu izini. Ƙarƙashin yanayi mai ma'ana, ana iya amfani da wasu hanyoyin da suka dace don yada waɗannan Takaddun Gaskiya, waɗanda zasu iya haɗa da kafofin watsa labarai.
Dakunan gwaje-gwaje masu izini masu amfani da samfurin ku dole ne suyi amfani da samfurin ku kamar yadda aka tsara a cikin alamar izini. Ba a ba da izini ba daga hanyoyin da aka ba da izini, gami da kayan aiki masu izini, nau'ikan samfuran asibiti masu izini, kayan sarrafawa masu izini, wasu madaidaitan ma'auni, da kayan izini da ake buƙata don amfani da samfur naka.
Dole ne dakunan gwaje-gwaje masu izini waɗanda suka karɓi kayanku su sanar da hukumomin lafiya na jama'a da suka dace da niyyar gudanar da aikinku kafin fara gwajin.

Dole ne dakunan gwaje-gwajen da aka ba da izini ta amfani da samfurinku su kasance suna da tsari don bayar da rahoton sakamakon gwajin ga masu ba da lafiya da hukumomin kiwon lafiyar da suka dace, kamar yadda ya dace.
Dakunan gwaje-gwaje masu izini dole ne su tattara bayanai kan aikin samfuran ku kuma suyi rahoto zuwa DMD/OHT7-OIR/OPEQ/CDRH (ta imel: CDRH-EUA-Reporting@fda.hhs.gov) da Quidel (ta imel:
QDL.COV2.test.event.report@quidel.com, ko ta waya ta hanyar tuntuɓar Sabis na Tallafin Abokin Ciniki na Quidel a 800.874.1517 (a cikin Amurka) ko 858.552.1100) duk wani abin da ake zargin ya faru na tabbataccen sakamako na ƙarya ko ƙarya da kuma karkata. daga ƙayyadaddun halaye na aikin samfuran ku waɗanda suka sani.
Duk masu aiki da ke amfani da kayan ka dole ne a basu horo yadda ya kamata wajen aiwatarwa da fassara sakamakon abin ka, yi amfani da kayan aikin sirri na sirri lokacin sarrafa wannan kayan, kuma yi amfani da kayan ka daidai da lasisin da aka ba izini.

Kamfanin Quidel, masu rabawa masu izini, da dakunan gwaje-gwaje masu izini masu amfani da samfurin ku dole ne su tabbatar da cewa ana kiyaye duk wani bayanan da ke da alaƙa da wannan EUA har sai FDA ta sanar da su. Dole ne a samar da irin waɗannan bayanan ga FDA don dubawa akan buƙata.

AIKI NA KWANA

An kwatanta Gwajin Antigen na QuickVue SARS zuwa Binciken da aka Cire EUA SARS-CoV-2 RT-PCR Assay ta amfani da daskararru da sabbin madaidaitan samfuran swab na baya.
Dari da hamsin da shida (156) madaidaicin samfuran swab na baya daga marasa lafiya da ake zargin suna da COVID-19 a cikin kwanaki biyar na farkon alamun an samo su daga rukunin yanar gizon Amurka uku. An aika da samfuran akan fakitin sanyi zuwa dakin gwaje-gwaje na Quidel a Athens, Ohio. Binciken da aka fitar na SARS-CoV-2 RT-PCR Assay gwajin an yi shi akan ɗayan swabs ɗin da suka dace daidai da umarnin na'urar don amfani. Hamsin da shida (56) na sauran swabs an daskararsu a -70°C kafin gwaji tare da gwajin Antigen na QuickVue SARS. A ranar gwajin QuickVue an narke swabs kuma an gwada su tare da gwajin Antigen na QuickVue SARS. An gwada swabs ɗari (100) sabo ne, a cikin awoyi 24 na tarin, tare da Gwajin Antigen na QuickVue SARS.

Talatin da takwas (38) daidaitattun nares swab samfurori daga marasa lafiya da ake zargin suna da COVID-19 a cikin kwanaki biyar na farkon alamun an samo su daga binciken da ake yi na asibiti mai zuwa a wuraren POC guda uku (3), tare da biyu (2) mafi ƙarancin horarwa. masu aiki a kowane rukunin POC. An gwada swab ɗaya a wurin POC tare da Gwajin Antigen na QuickVue SARS ta wasu ma'aikatan da ba su da isasshen horo a ranar tattarawa. An ba wa masu aiki umarnin gwaji kawai da jagorar tunani mai sauri. An aika madaidaicin swabs akan fakitin sanyi zuwa dakin gwaje-gwaje na Quidel a Athens, Ohio don gwajin SARS-CoV-2 RT-PCR. Binciken da aka fitar na SARS-CoV-2 RT-PCR Assay gwajin an yi shi akan swabs ɗin daidai da umarnin na'urar don amfani.

Teburin da ke ƙasa yana taƙaita bayanai daga sabbin samfurori (138) da daskararre (56)

Kwatanta na QuickVue SARS Antigen Test da izini EUA Kwatancen Kwatancen Kwatancen tare da daidaitacce. gaban nares swabs
Nau'in samfur	Lamba An gwada	Gaskiya M	Karya M	Gaskiya Korau	Karya Korau	PPA%	NPA%	PPA 95% CI	NPA 95% CI
Sabbin Samfura	138	30	1	106	1	96.8	99.1	83.8 zuwa 99.4	94.9 zuwa 99.8
Daskararre Samfura	56	26	0	29	1	96.3	100	81.7 zuwa 99.3	88.3 zuwa 100
Haɗe Samfura	194	56	1	135	2	96.6	99.3	88.3 zuwa 99.0	96.0 zuwa 99.9

YADDA AKA YI KYAUTA

Iyakar Ganewa

Iyakar Ganewa (LoD) na QuickVue SARS Antigen Test an ƙaddara ta amfani da iyakance dilutions na SARS-CoV-2 da ba a kunna zafi ba (ZeptoMetrix 0810587CFHI). Kayan ZeptoMetrix shiri ne na SARS-Related Coronavirus 2 (SARS-CoV-2), keɓe USA-WA1/2020, wanda aka kunna ta dumama a 65 ° C na mintuna 30. An kawo kayan a daskararre a adadin 1.15 x107 TCID50/ml.
Nazarin don ƙayyade QuickVue SARS Antigen Test LoD an tsara shi don nuna ƙima yayin amfani da swabs kai tsaye. A cikin wannan binciken, an zubar da swab NP tare da kusan 50-µL na ƙwayar ƙwayar cuta a cikin saline. An ƙara swab ɗin spiked a cikin QuickVue SARS Antigen Test Extract a lokaci guda zuwa NP swab mai ɗauke da matrix NP. An sarrafa swabs a lokaci guda bisa ga abin da aka saka.
An ƙaddara LoD a matakai uku

Gano LoD
An yi ninki 10 na ƙwayoyin cuta masu zafi a cikin gishiri kuma ana sarrafa su don kowane bincike kamar yadda aka bayyana a sama. An gwada waɗannan dilutions sau uku. An zaɓi mafi ƙarancin maida hankali mai nuna 3 na 3 tabbatacce don gano kewayon LoD. Dangane da wannan gwajin, ƙaddamarwar da aka zaɓa shine TCID50 na 1.51 x104.
Nemo Range na LoD
An yi dilutions guda uku (3) na 1.51 x104 maida hankali a cikin salin da aka sarrafa don binciken kamar yadda aka bayyana a sama. An gwada waɗannan dilutions sau uku. An zaɓi mafi ƙanƙancin taro mai nuna 3 na 3 tabbatacce don tabbatar da LoD. Dangane da wannan gwajin abin da aka zaɓa shine 7.57 x103.
Tabbatar da LoD
An gwada maida hankali na 7.57 x103 dilution sau ashirin (20). Sakamakon ashirin (20) cikin ashirin (20) sun kasance tabbatacce. Dangane da wannan gwajin an tabbatar da maida hankali azaman TCID50 na 7.57 x103.

Reactivity na Nazari/Hadawa
An ƙididdige martanin nazarin ƙwayoyin rigakafin ƙwayoyin cuta na monoclonal da ke niyya SARS-CoV-2 a cikin gwajin Antigen na QuickVue SARS tare da nau'in SAR-CoV-2 da ake samu a halin yanzu (duba tebur a ƙasa).

2019-nCoV Strain/Warewa	Source/Sampda Type	Hankali
USA-WA1/2020	ZeptoMetrix 0810587CFHI	1.15x10 ku⁷ TCID50/ml

Cross-Reactivity

An ƙididdige-reactivity na ƙwayoyin rigakafin monoclonal da aka yi amfani da su don gano SARS-CoV-2 ta hanyar gwada ƙwayoyin cuta daban-daban (12) da ƙwayoyin cuta (16) waɗanda ke iya yuwuwar amsawa tare da Gwajin Antigen SARS na QuickVue. An gwada kowace kwayar halitta da kwayar cuta sau uku. Ƙarshe na ƙarshe na kwayoyin halitta da ƙwayoyin cuta an rubuta su a cikin jadawalin da ke ƙasa

Rikici-Reactivity/ Tsangwama na Gwajin Antigen SARS na QuickVue
Virus/Bacteria/Parasite	Iri	Source/Sample nau'in	Hankali	Sakamako na Tsare-tsare*	Sakamakon Tsangwama*
Adenovirus	Farashin 1	Ware	1 x 10^5.53 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Coronavirus	229e	Ware	1 x 10^5.10 U/ml	Babu Cross-Reactivity	Babu Tsangwama

Rikici-Reactivity/ Tsangwama na Gwajin Antigen SARS na QuickVue
Virus/Bacteria/Parasite	Iri	Source/Sample nau'in	Hankali	Sakamako na Tsare-tsare*	Sakamakon Tsangwama*
Coronavirus	OC43	Ware	9.55 x 10⁵ TCID50/ml	Babu Cross-Reactivity	Babu Tsangwama
Coronavirus	NL63	Ware	5 x 10^3.67 U/ml	Babu Cross-Reactivity	Babu Tsangwama
MERS-CoV (ba a kunna zafi)	Florida/USA- 2_Saudi Arab_2014	Ware	1.17 x 10⁵ TCID50/ml	Babu Cross-Reactivity	Babu Tsangwama
Mycoplasma pneumoniae	M129	Ware	3 x 10⁶ CCU/ml**	Babu Cross-Reactivity	Babu Tsangwama
Streptococcus pyogenes	Z018	Ware	3.8 x 10⁶ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
M mura A H3N2	Brisbane/10/07	Ware	1 x 10^5.07 U/ml	Babu Cross-Reactivity	Babu Tsangwama
M mura A H1N1	Sabo Caledonia/20/99	Ware	1 x 10^5.66 U/ml	Babu Cross-Reactivity	Babu Tsangwama
mura B	Brisbane/33/08	Ware	1 x 10^5.15 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Parainfluenza	Farashin 1	Ware	1 x 10^5.01 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Parainfluenza	Farashin 2	Ware	1 x 10^5.34 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Parainfluenza	Farashin 3	Ware	8.5 x 10⁵ TCID50/ml	Babu Cross-Reactivity	Babu Tsangwama
Parainfluenza	Nau'in 4b	Ware	1 x 10^5.53 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Enterovirus	Farashin 68	Ware	1 x 10^5.5 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Mutum Metapneumovirus	A1 (IA10-s003)	Ware	1 x 10^5.55 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Haɗin kai na numfashi Ƙwayar cuta	Nau'in A (3/2015 Warewa #3)	Ware	1 x 10^5.62 U/ml	Babu Cross-Reactivity	Babu Tsangwama
Rhinovirus na mutum	N/A	Rashin kunnawa ƙwayar cuta	Ba akwai ***	Babu Cross-Reactivity	Babu Tsangwama
Chlamydophila ciwon huhu	AR-39	Ware	2.9 x 10⁶ IFU/ml****	Babu Cross-Reactivity	Babu Tsangwama
Haemophilus mura	Rubuta b; Eagan	Ware	7.87 x 10⁶ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Legionella cutar pneumophila	Philadelphia	Ware	6.82 x 10⁶ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Streptococcus ciwon huhu	Z022; 19 f	Ware	2.26 x 10⁶ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Bordetella pertussis	A639	Ware	6.37 x 10⁶ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Pneumocystis jirovecii-S. girki Mai haɗawa	W303-Pji	Ware	1.56 x 10⁶ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Mycobacterium tarin fuka	Bayanin H37Ra-1	Ware	6.86 x 10⁷ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Staphylococcus epidermis	MRSE; Saukewa: RP62A	Ware	1.21 x 10¹⁰ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Staphylococcus aureus MSSA	Farashin NCTC8325	Ware	5.5 x 10⁹ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama

Rikici-Reactivity/ Tsangwama na Gwajin Antigen SARS na QuickVue
Virus/Bacteria/Parasite	Iri	Source/Sample nau'in	Hankali	Sakamako na Tsare-tsare*	Sakamakon Tsangwama*
Staphylococcus aureus MRSA	0801638	Ware	1.38 x 10¹⁰ cfu/ml	Babu Cross-Reactivity	Babu Tsangwama
Ba a gwada coronavirus HKU1 don sake kunnawa ba saboda rashin samuwa. An gwada samfurori 19 da ke ɗauke da Coronavirus HKU1 kuma duk sun haifar da mara kyau, ƙarin gwajin jiƙa na giciye ba a buƙata ba.

* An yi gwaji sau uku
**CCU/ml shine Unit Canjin Launi kamar yadda aka lissafta bisa ga ingantaccen hanyar Reed-Muench dangane da dilutions wanda ya haifar da canjin launi a cikin broth.

*** Kwayar cuta ba ta aiki ba tare da ƙididdige ƙididdiga ba.
**** IFU/ml raka'a ce mai yaduwa a kowace millilita

Tasirin ƙugiya

A matsayin wani ɓangare na binciken LoD, an gwada mafi girman taro na hannun jari na SARS-CoV-2 da ba a kunna zafi ba (TCID50 na 3.40 x105 kowace ml). Babu wani tasirin ƙugiya da aka gano.

Nazarin Abubuwan Hana Harka

An gudanar da bincike don nuna cewa abubuwa ashirin (20) masu yuwuwar shiga tsakani waɗanda za a iya samu a cikin manyan hanyoyin numfashi ba sa tsangwama ko tsoma baki tare da gano SARS-CoV-2 a cikin QuickVue SARS Antigen Test.

Abubuwan Yiwuwar Tsangwama don Gwajin Antigen SARS na QuickVue
Abu	Abunda yake aiki	Hankali	Cross-Reactivity Sakamako*	Tsangwama Sakamako*
Afrin - maganin hanci	Oxymetazoline	5%	Babu Cross-Reactivity	Babu Tsangwama
Homeopathic (Alkalol)	Galphimia glauca, Luffa operculate, Sabadilla	10X	Babu Cross-Reactivity	Babu Tsangwama
Jini (dan Adam)	Jini	5%	Babu Cross-Reactivity	Babu Tsangwama
Chloraseptic, Cepacol	Benzocaine, Menthol	0.7 g/ml	Babu Cross-Reactivity	Babu Tsangwama
CVS fesa makogwaro	Phenol	1.4%
Flonase	Fluticasone	5%	Babu Cross-Reactivity	Babu Tsangwama
Halls Relief Cherry Dadi	Menthol	0.8 g/ml	Babu Cross-Reactivity	Babu Tsangwama
Maganin shafawa Mupirocin	Mupirocin	2% w/w	Babu Cross-Reactivity	Babu Tsangwama
Nasacort Allergy 24 awa	Triamcinolone	5.00%	Babu Cross-Reactivity	Babu Tsangwama
NasalCrom Spray	Cromolyn sodium	5.2mg ku	Babu Cross-Reactivity	Babu Tsangwama
NeilMed SinuFlow Shirya Kurkura	Sodium chloride, sodium chloride bicarbonate	Ba akwai**	Babu Cross-Reactivity	Babu Tsangwama
NeilMed SinuFrin Plus	Oxymetazoline HCl	0.05%	Babu Cross-Reactivity	Babu Tsangwama
Neo-Synephrine	Phenylephrine hydrochloride	5%	Babu Cross-Reactivity	Babu Tsangwama
Oseltamivir	Oseltamivir	2.2 μg/ml	Babu Cross-Reactivity	Babu Tsangwama

Abubuwan Yiwuwar Tsangwama don Gwajin Antigen SARS na QuickVue
Tsarkake mucin furotin	Mucin protein	2.5 mg/ml	Babu Cross-Reactivity	Babu Tsangwama
Rhinocort	Budesonide (Glucocorticosteroids)	5%	Babu Cross-Reactivity	Babu Tsangwama
Saline spray na hanci	Saline	15%	Babu Cross-Reactivity	Babu Tsangwama
Tobramycin	Tobramycin	1.25 mg/ml	Babu Cross-Reactivity	Babu Tsangwama
Zanamivir	Zanamivir	282.0ng/ml	Babu Cross-Reactivity	Babu Tsangwama
Maganin Ciwon Zicam	Galphimia glauca, Luffa operculate, Sabadilla	5%	Babu Cross-Reactivity	Babu Tsangwama

* An yi gwaji sau uku
** Ba a bayar da maida hankali a cikin alamar samfur ba

TAIMAKA

Idan kuna da wasu tambayoyi game da amfani da wannan samfur, da fatan za a kira lambar Tallafin Fasaha ta Quidel 800.874.1517 (a cikin Amurka) ko 858.552.1100, Litinin zuwa Juma'a, daga 7:00 na safe zuwa 5:00 na yamma, Lokacin Pacific. Idan a wajen Amurka, tuntuɓi mai rarrabawa na gida ko technicalsupport@quidel.com. Hakanan za'a iya ba da rahoton matsalolin tsarin gwaji ga FDA ta hanyar shirin ba da rahoton samfuran likita na MedWatch (wayar:
800.FDA.1088; fax: 800.FDA.0178; http://www.fda.gov/medwatch).

NASARA

Baker, S., Frias, L., da Bendix, A. Sabuntawar rayuwa ta Coronavirus: Fiye da mutane 92,000 sun kamu da cutar kuma aƙalla 3,100 sun mutu. Amurka ta ba da rahoton mutuwar mutane 6. Ga duk abin da muka sani. Insider Kasuwanci. Maris 03, 2020.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen

Clinical and Laboratory Standards Institute. Al'adun Kwayoyin cuta; Sharuɗɗan Amintattu. CLSI daftarin aiki M41-A [ISBN 1562386239] Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, Amurka 2006.
Lauer, SA, et. al. Lokacin shigar cutar Coronavirus 2019 (COVID-19) daga shari'o'in da aka tabbatar da jama'a: kimantawa da aikace-aikace, Ann Intern Med. 2020
Biosafety a cikin Microbiological da Biomedical dakunan gwaje-gwaje, 5th Edition. Ma'aikatar Kiwon Lafiya ta Amurka da Ayyukan Dan Adam, CDC, NIH, Washington, DC (2007).

Henretig FM MD, Sarki C. MD. Littafin Karatun Ayyukan Yara, Babi na 123 - Samun Samfuran Halittu Williams da Williams (Afrilu 1997).
Laboratory Virology Laboratory, Ma'aikatar Magungunan Laboratory a Yale: http://info.med.yale.edu/labmed/virology/booklet.html.
Shirin Gudanarwa na Ostiraliya don Cutar Mura - Sashe na 5 Annex 5: Sharuɗɗan Laboratory.

Takardu / Albarkatu

	QUIDEL QuickVue SARS Antigen Gwajin [pdf] Jagoran Jagora Gwajin Antigen na QuickVue SARS, QuickVue, SARS, Gwajin Antigen
	QUIDEL QuickVue SARS Antigen Gwajin [pdf] Jagoran Jagora Gwajin Antigen na QuickVue SARS
	QUIDEL QuickVue SARS Antigen Gwajin [pdf] Umarni Gwajin Antigen SARS QuickVue, QuickVue, Gwajin Antigen SARS, Gwajin Antigen, Gwaji