Mayeso a Antigen a QUIDEL QuickVue SARS
ZOFUNIKA KUGWIRITSA NTCHITO
QuickVue SARS Antigen Test ndi lateral flow immunoassay yomwe imalola kuzindikira mwachangu, moyenera kwa nucleocapsid protein antigen kuchokera ku SARS-CoV-2 in anterior nares (NS) swab specimens mwachindunji kuchokera kwa anthu omwe akuwaganizira kuti ali ndi COVID-19 ndi chisamaliro chawo chaumoyo. wopereka chithandizo mkati mwa masiku asanu oyambirira zizindikiro zayamba. Kuyesa kumangoperekedwa ku ma laboratories ovomerezeka pansi pa Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, omwe amakwaniritsa zofunikira kuti ayesedwe mozama, apamwamba, kapena ochotsedwa. Mayesowa amaloledwa kugwiritsidwa ntchito ku Point of Care (POC), mwachitsanzo, malo osamalira odwala omwe ali pansi pa CIA Certificate of Waiver, Certificate of Compliance, kapena Certificate of Accreditation. Mayeso a QuickVue SARS Antigen samasiyanitsa pakati pa SARS-CoV ndi SARS-CoV-2. Zotsatira ndikuzindikiritsa SARS-CoV-2 nucleocapsid protein antigen. Ma antigen nthawi zambiri amawonekera m'zitsanzo za nares zakunja panthawi yovuta kwambiri ya matenda. Zotsatira zabwino zimasonyeza kukhalapo kwa tizilombo toyambitsa matenda, koma mgwirizano wachipatala ndi mbiri ya odwala ndi zina zowunikira ndizofunikira kuti mudziwe momwe matenda alili. Zotsatira zabwino sizimaletsa matenda a bakiteriya kapena kupatsirana ndi ma virus ena. Wothandizira wapezeka sangakhale wotsimikizika chifukwa cha matendawa. Ma laboratories aku United States ndi madera ake akuyenera kufotokoza zotsatira zonse kwa akuluakulu oyenerera azaumoyo. Zotsatira zoyipa ziyenera kuchitidwa ngati zongoganizira komanso kutsimikizira ndi kuyesa kwa maselo, ngati kuli kofunikira, pakuwongolera odwala, kutha kuchitidwa. Zotsatira zoyipa sizimaletsa COVID-19 ndipo siziyenera kugwiritsidwa ntchito ngati maziko okhawo opangira chithandizo kapena zisankho zowongolera odwala, kuphatikiza zisankho zolimbana ndi matenda. Zotsatira zoyipa ziyenera kuganiziridwa potengera zomwe wodwala wakumana nazo posachedwa, mbiri yake, komanso kupezeka kwa zizindikiro zachipatala zomwe zimagwirizana ndi COVID-19. Mayeso a QuickVue SARS Antigen adapangidwa kuti azigwiritsidwa ntchito ndi ogwira ntchito zachipatala ophunzitsidwa bwino komanso anthu ophunzitsidwa bwino za chisamaliro. Mayeso a QuickVue SARS Antigen amangogwiritsidwa ntchito pansi pa Food and Drug Administration's Emergency Use Authorization.
CHIWUTSO NDI MAFOTO
SARS-CoV-2, yomwe imadziwikanso kuti kachilombo ka COVID-19, idadziwika koyamba ku Wuhan, Chigawo cha Hubei, China mu Disembala 2019. Kachilomboka, monga momwe zilili ndi buku la coronavirus SARS-1 ndi MERS, akuti adachokera ku mileme. Komabe, a SARS-CoV-2 atha kukhala kuti anali ndi mkhalapakati monga ma pangolin, nkhumba, kapena civets.1 WHO idalengeza kuti COVID-19 inali mliri pa Marichi 11, 2020, ndipo matenda a anthu afalikira padziko lonse lapansi mazana masauzande a matenda otsimikizika ndi imfa.2 Nthawi yofikira pakatikati ikuyerekezedwa kukhala masiku 5.1 ndipo zizindikiro zikuyembekezeka kupezeka mkati mwa masiku 12 mutadwala. chifuwa, ndi kupuma movutikira.3
MFUNDO YA NJIRA
Mayeso a QuickVue SARS Antigen amagwiritsa ntchito ukadaulo wa lateral flow immunoassay. Kugwiritsa ntchito mayesowa kumathandizira kuzindikira mwachangu mapuloteni a nucleocapsid kuchokera ku SARS-CoV ndi SARS-CoV-2. Mayesowa amalola kuzindikira kwa SARS-CoV ndi SARS-CoV-2 koma samasiyanitsa ma virus awiriwa.
Kuti ayambe kuyezetsa, reagent ya lyophilized iyenera kubwezeretsedwanso mu chubu la Reagent. Reagent iyi imathandizira kuwonekera kwa ma antigen oyenera a virus ku ma antibodies omwe amagwiritsidwa ntchito poyesa. The Reagent imayikidwanso madzi m'thupi ndi Reagent Solution yoperekedwa, ndipo chitsanzo cha swab chimayikidwa mu Reagent Tube. Reagent iyi imalumikizana ndi chitsanzocho ndipo imathandizira kuwonekera kwa ma antigen oyenera a virus ku ma antibodies omwe amagwiritsidwa ntchito poyesa. Mzere Woyeserera wawonjezedwa ku Reagent Tube yomwe ili ndi chitsanzo ndi Reagent Solution.
Ngati chitsanzo chochotsedwacho chili ndi ma antigen a SARS-CoV kapena SARS-CoV-2, Mzere Woyesa wa pinki mpaka wofiira, pamodzi ndi Mzere Wowongolera wabuluu udzawonekera pa Test Strip kusonyeza zotsatira zabwino. Ngati SARS-CoV kapena SARS-CoV-2 palibe kapena ilipo pamiyezo yotsika kwambiri, ndi mzere wowongolera wabuluu wokha womwe udzawonekere.
REAGENTS NDI Zipangizo ZOPEREKA
25-Zida Zoyesera
- Mizere Yoyeserera Payekha Payekha (25): Ma antibodies a monoclonal anti-SARS
- Machubu a Reagent (25): Chotchinga cha Lyophilized chokhala ndi zotsukira ndi zochepetsera
- Reagent Solution (25): Mbale zokhala ndi 340 μL mchere
- Osabala Mphuno Swabs (Kit #20387) (25)
- SARS Positive Control Swab (1): Swab imakutidwa ndi ma antigen osapatsirana a SARS
- Negative Control Swab (1): Swab imakutidwa ndi antigen ya Streptococcus C yosayambitsa kutentha, yopanda matenda.
- Phukusi Ikani (1)
- Ndondomeko ya Khadi (1)
ZINTHU ZOSAPATSIDWA
- Nthawi kapena wotchi
- QuickVue SARS Antigen Control Swab Yakhazikitsidwa kwa QC yowonjezera (20389)
- Dry transport chubu (SKU # 20385) (25). Sungani kutentha.
CHENJEZO NDI CHENJEZO
- Kuti mugwiritse ntchito mu vitro diagnostic
- Kugwiritsa ntchito mankhwala okha
- Mankhwalawa sanachotsedwe kapena kuvomerezedwa ndi FDA; koma waloledwa ndi FDA pansi pa Authorization Emergency Use Authorization (EUA) kuti agwiritsidwe ntchito ndi ma laboratories ovomerezeka pansi pa CLIA omwe amakwaniritsa zofunikira kuti ayesetse mozama, apamwamba, kapena ochotsedwa. Mankhwalawa amaloledwa kugwiritsidwa ntchito ku Point of Care (POC), mwachitsanzo, malo osamalira odwala omwe akugwira ntchito pansi pa CLIA Certificate of Waiver, Certificate of Compliance, kapena Certificate of Accreditation.
- Katunduyu adavomerezedwa kokha kuti azindikire mapuloteni ochokera ku SARS-CoV-2, osati ma virus kapena tizilombo tina tina.
- Kuyezetsa kumeneku kumaloledwa kokha panthawi yomwe chilengezo chakuti mikhalidwe ilipo yovomerezeka kuvomereza kwadzidzidzi kwa mayeso a in vitro diagnostic kuti azindikire komanso / kapena kuzindikira COVID-19 pansi pa Gawo 564(b)(1) la Act, 21 USC. § 360bbb-3 (b) (1) pokhapokha ngati chilolezocho chathetsedwa kapena kuchotsedwa posachedwa.
- Musagwiritse ntchito zomwe zili mkati mwa tsiku lomaliza lomwe lidasindikizidwa kunja kwa bokosilo.
- Valani zovala zodzitchinjiriza zoyenera, magolovesi (nitrile kapena latex), komanso chitetezo chamaso/nkhope pogwira ntchito ya wodwala.ampzida kapena zida zomwe zimagwiritsidwa ntchito.
- The Reagent Solution ili ndi yankho la mchere (saline). Ngati yankho likukhudza khungu kapena diso, tsukani ndi madzi ochuluka.
- Osagwiritsanso ntchito Test Strip, Reagent Tubes, mayankho, kapena Control Swabs.
- Test Strip iyenera kukhala yosindikizidwa mu thumba lazotchinga zoteteza mpaka itagwiritsidwa ntchito. Wogwiritsa asatsegule thumba lazojambula la Test Strip ndikuliwonetsa kumalo ozungulira mpaka Test Strip itakonzeka kugwiritsidwa ntchito nthawi yomweyo. Ngati mzere woyesera uli wotseguka kwa ola limodzi kapena kupitilira apo, zotsatira zoyeserera zitha kuchitika.
- Mayeso a QuickVue SARS Antigen akuyenera kugwiritsidwa ntchito ndi chotchinga chotchinga chokhazikika komanso njira yolumikizirana yoperekedwa mu zida.
- Kusonkhanitsa koyenera kwa zitsanzo, kusungirako, ndi zoyendera ndizofunikira kwambiri pakuchita kwa mayesowa. Fufuzani maphunziro kapena chitsogozo chapadera ngati mulibe luso la kusonkhanitsa ndi kasamalidwe ka zitsanzo.5,6,7,8
- Potolera mphuno swab sample, gwiritsani ntchito swab ya m'mphuno yoperekedwa mu zida (Kit #20387)
- Kusakwanira kapena kosayenera kwa zitsanzo, kusungidwa, ndi zonyamulira zitha kubweretsa zotsatira zabodza.
- Kuti mupeze zotsatira zolondola, muyenera kutsatira malangizo a Package Insert.
- Anthu omwe ali ndi vuto la maso sangathe kutanthauzira mokwanira zotsatira za mayeso.
- Kuyezetsa kuyenera kuchitidwa m'dera lomwe muli mpweya wokwanira.
- Tayani zotengera ndi zomwe sizinagwiritsidwe ntchito molingana ndi zofunikira za Federal, State, and Local regulatory.
- Sambani m'manja bwinobwino mukagwira.
- Kuti mumve zambiri zachitetezo, kasamalidwe, ndi kutaya kwazinthu zomwe zili mkati mwa zidazi, chonde onani tsamba la Safety Data Sheet (SDS) lomwe lili pa quidel.com.
KIT YOSUNGA NDI Kukhazikika
- Sungani zidazi pamalo otentha, 59 ° F mpaka 86 ° F (15 ° C mpaka 30 ° C), kunja kwa dzuwa. Zomwe zili m'kati mwa zida ndizokhazikika mpaka tsiku lotha ntchito litasindikizidwa pabokosi lakunja. Osaundana.
KUSANTHULA KWAMBIRI NDI KUSUNGIRA - Kusonkhanitsidwa koyenera kwa zitsanzo ndi kagwiridwe kake ndizofunikira kwambiri pakuchita mayesowa.5,6,7,8 Chitsanzo Chotolera Mphuno Swab S.ample
- Gwiritsani ntchito swab ya m'mphuno yoperekedwa muzovala.
- Asanayambe kusonkhanitsa swab ya mphuno, wodwalayo ayenera kulangizidwa kuti aziwombera mphuno. Kusonkhanitsa swab ya m'mphuno sample, ikani nsonga yonse yoyamwa ya swab (nthawi zambiri ½ mpaka ¾ ya inchi (1 mpaka 1.5 cm) mkati mwa mphuno ndi mwamphamvu samplembani khoma la m'mphuno potembenuza swab mozungulira mozungulira khoma lamphuno osachepera kanayi. Tengani pafupifupi masekondi 4 kuti mutenge sample. Onetsetsani kuti mwasonkhanitsa ngalande za m'mphuno zilizonse zomwe zingakhalepo pa swab.
- Sample mphuno zonse ziwiri ndi swab yemweyo.
Sample Transport and Storage Samples ayenera kuyesedwa mwamsanga pambuyo kusonkhanitsa. Kutengera ndi data yopangidwa ndi QuickVue SARS Antigen Test, nsonga zam'mphuno zimakhala zokhazikika mpaka maola 120 kutentha kwachipinda kapena 2 ° mpaka 8 ° C muchubu choyera, chowuma.
KUKHALA KWAKHALIDWE
Pali mitundu iwiri yayikulu ya Kuwongolera Kwabwino kwa chipangizochi: zida zomangidwira zomwe zafotokozedwa pansipa ndi zowongolera zakunja.
Mawonekedwe Owongolera Omangidwa
Mayeso a QuickVue SARS Antigen ali ndi machitidwe owongolera okhazikika. Malingaliro a wopanga pakuwongolera tsiku ndi tsiku ndikulemba maulamuliro awa omangidwira m'magawo oyambaampndiyesedwa tsiku lililonse.
Zotsatira zamitundu iwiri zimapereka kutanthauzira kosavuta kwa zotsatira zabwino ndi zoipa. Maonekedwe a blue Procedural Control Line amapereka chiwongolero chabwino mwa kusonyeza kuyenda kokwanira kwachitika ndipo kukhulupirika kwa ntchito ya Test Strip kunasungidwa. Ngati mzere wa blue Procedural Control Line sunapangidwe mkati mwa mphindi 10 pa Test Strip, ndiye kuti zotsatira zake sizolondola.
Kuwongolera kolakwika komwe kumapangidwira kumaperekedwa ndi kuyeretsedwa kwa mtundu wofiira wakumbuyo, kutsimikizira kuti mayesowo achitidwa molondola. Pakadutsa mphindi 10, gawo lotsatila liyenera kukhala loyera mpaka pinki ndikulola kutanthauzira momveka bwino kwa zotsatira za mayeso. Ngati mtundu wakumbuyo ukhalabe ndikusokoneza kutanthauzira kwa zotsatira zoyeserera, ndiye kuti zotsatira zake ndizosavomerezeka. Izi zikachitika, review njirayi ndikubwereza mayeso ndi wodwalayo watsopanoample ndi Test Strip yatsopano. M'pofunika kusonkhanitsa chitsanzo cha wodwala wina; swabs odwala kapena reagents sangathe kugwiritsidwanso ntchito.
Kunja Quality Control
Zowongolera Zakunja zitha kugwiritsidwanso ntchito kuwonetsa kuti ma reagents ndi njira zoyeserera zikuyenda bwino.
Quidel amalimbikitsa kuti zowongolera zabwino ndi zoyipa ziziyendetsedwa kamodzi kwa wogwiritsa ntchito aliyense wosaphunzitsidwa, kamodzi pa chilichonse chotumiza chatsopano - bola ngati magawo osiyanasiyana omwe alandilidwa amayesedwa - komanso monga zikuwonekeranso kuti ndizofunikira ndi njira zanu zowongolera zamkati, komanso malinga ndi zomwe mwatumiza. ndi malamulo am'deralo, boma ndi federal kapena zofunikira zovomerezeka.
Njira Yoyesera yomwe ikufotokozedwa mu Package Insert iyenera kugwiritsidwa ntchito poyesa zowongolera zakunja.
Ngati zowongolera sizikuyenda momwe mukuyembekezeredwa, bwerezani mayesowo kapena funsani Quidel Technical Support musanayese zitsanzo za odwala.
Zowonjezera Zowongolera Zitha kupezeka padera polumikizana ndi Quidel's Customer Support Services pa (800) 874.1517 (yaulere ku USA) kapena (858) 552.1100.
NJIRA YOYESA
Zida zoyesera ndi zitsanzo zachipatala ziyenera kukhala kutentha kozizira musanayambe kuyesa.
Tsiku lotha ntchito: Yang'anani kutha kwa paketi iliyonse yoyeserera kapena bokosi lakunja musanagwiritse ntchito. Osagwiritsa ntchito mayeso aliwonse atadutsa tsiku lotha ntchito palembalo.
Njira Yoyeserera ya Nasal Swab
- Onjezani Reagent Solution ku Reagent Tube. Pang'onopang'ono tembenuzani chubu kuti musungunuke zomwe zili mkati mwake.
- The Reagent Tube iyenera kukhalabe mu chotengera chubu nthawi yonse yoyezetsa.
- Nthawi yomweyo ikani swab wodwala sampkulowa mu Reagent Tube. Pereka swab osachepera katatu (3) ndikukankhira mutu pansi ndi mbali ya Reagent Tube.
- Sungani swab mu chubu kwa mphindi imodzi (1).
- Zotsatira zolakwika kapena zosayenera zikhoza kuchitika ngati nthawi yoyamwitsa ili yochepa kwambiri kapena yayitali kwambiri.
- Onetsani zamadzi zonse kuchokera kumutu wa swab pogudubuza swab osachepera katatu (3) pamene swab ikuchotsedwa. Tayani swab motsatira ndondomeko yanu yotaya zinyalala za biohazard.
- Ikani Mzere Woyesera mu Reagent Tube ndi mivi yolozera pansi. Osagwira kapena kusuntha Test Strip mpaka mayeso atamaliza ndikukonzekera kuwerengedwa.
- Pakadutsa mphindi khumi (10), chotsani Test Strip, ndikuwerenga zotsatira mkati mwa mphindi zisanu (5) molingana ndi gawo la Interpretation of Results.
Mizere yoyeserera iyenera kuwerengedwa pakati pa mphindi 10 ndi 15 mutayika mu Reagent Tube. Zotsatira zabodza, zabodza, kapena zotsatira zosavomerezeka zitha kuchitika ngati mzerewo wawerengedwa kupyola nthawi yovomerezeka.
KUMASULIRIDWA KWA ZOTSATIRA
- Zotsatira Zabwino*:
- Pamphindi khumi (10), maonekedwe a mthunzi ULIWONSE wa Mzere Woyesera wa pinki-to-red NDI maonekedwe a blue procedural Control Line amasonyeza zotsatira zabwino za kupezeka kwa SARS antigen. Zotsatira zidzakhala zokhazikika kwa mphindi zisanu (5) pambuyo pa nthawi yowerengera yovomerezeka. Osawerenga zotsatira kuposa mphindi khumi ndi zisanu mutaziyika mu Reagent Tube.
- *Zotsatira zabwino sizimaletsa kupatsirana ndi matenda ena.
- ∗Yang'anani mwatcheru! Izi ndi zotsatira zabwino. Ngakhale muwona Mzere Woyesera wofiyira kwambiri, wapinki ndi Mzere Wowongolera wa buluu, muyenera kunena zotsatira zake ngati POSITIVE.
- C = Control Line
- T = Mzere Woyesera
Zotsatira zoyipa**:
- Pamphindi khumi (10), kuwoneka kwa Mzere wokha wa blue procedural Control Line umasonyeza kuti SARS antigen sinapezeke. Zotsatira zidzakhala zokhazikika kwa mphindi zisanu (5) pambuyo pa nthawi yowerengera yovomerezeka. Osawerenga zotsatira kuposa mphindi khumi ndi zisanu mutaziyika mu Reagent Tube.
- **Zotsatira zoyipa sizimapatula matenda a SARS-CoV-2. Zotsatira zoyipa ziyenera kuonedwa ngati zongopeka ndipo zingafunikire kutsimikiziridwa ndi kuyesa kwa ma molekyulu.
Zotsatira zolakwika
- Ngati pakatha mphindi khumi (10), mzere wa blue procedural Control Line suwoneka, ngakhale mthunzi uliwonse wa Pink-to-red Test Line utawoneka, zotsatira zake zimakhala zosavomerezeka.
- Ngati pa mphindi khumi (10), mtundu wakumbuyo suwoneka bwino ndipo umasokoneza kuwerenga kwa mayeso, zotsatira zake ndizosavomerezeka.
- Ngati zotsatira zake ndi zosavomerezeka, kuyezetsa kwatsopano kuyenera kuchitidwa ndi wodwala watsopano sample ndi Test Strip yatsopano.
ZOPHUNZITSA
- Mayesowa amapangidwa kuti azingotengera zitsanzo za swab zokha. Viral Transport Media (VTM) sayenera kugwiritsidwa ntchito ndi mayesowa chifukwa angayambitse zotsatira zabodza.
- Zomwe zili m'gululi zikuyenera kugwiritsidwa ntchito kokha pozindikira ma antigen a SARS kuchokera kumitundu yapamphuno ya nares.
- Zotsatira zoyipa zoyeserera zitha kuchitika ngati mulingo wa antigen mu asample ili pansi pa malire ozindikira mayeso kapena ngati sample adasonkhanitsidwa mosayenera.
- Kuyesaku kukuwunika zonse (zamoyo) komanso zosagwira, SARS-CoV, ndi SARS-CoV-2. Kuchita mayeso kumadalira kuchuluka kwa ma virus (antigen) mu sample ndipo mwina sizingagwirizane kapena sizingagwirizane ndi zotsatira za chikhalidwe cha ma virus zomwe zimachitika pamtundu womwewoample.
- Kukanika kutsatira Ndondomeko Yoyeserera ndi Kutanthauzira kwa Zotsatira kungasokoneze momwe mayeso akuyendera komanso/kapena kulepheretsa Zotsatira za Mayeso.
- Zotsatira Zoyesedwa ziyenera kuyesedwa limodzi ndi zidziwitso zina zamankhwala zomwe dokotala angapeze.
- Zotsatira zoyeserera zoyipa sizinapangidwe kuti zizilamulira m'matenda ena omwe si a SARS kapena bakiteriya.
- Zotsatira zabwino zoyezetsa sizimaletsa kupatsirana limodzi ndi tizilombo toyambitsa matenda.
- Zotsatira zoyipa ziyenera kuonedwa ngati zongoganizira, ndipo kutsimikiziridwa ndi kuyesa kwa maselo, ngati kuli kofunikira pakuwongolera odwala, kungatheke.
- Ngati pakufunika kusiyanitsa mavairasi ndi mavuto ena a SARS, kuyezetsa kowonjezerapo, pokambirana ndi madipatimenti aboma kapena am'deralo, kukufunika.
ZOYENERA KULAMULITSIDWA KWA LABORATORI NDI ZOKHUDZA ZOKHUDZA ODALI
- Letter of Authorization ya QuickVue SARS Antigen Test Letter, pamodzi ndi Fact Sheet for Healthcare Providers, Fact Sheet for Patients ovomerezeka, ndi zilembo zovomerezeka zilipo pa FDA. webTsamba: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
- Komabe, kuthandiza ma laboratories azachipatala pogwiritsa ntchito QuickVue SARS Antigen Test ("chinthu chanu" mumikhalidwe ili pansipa), Mikhalidwe Yovomerezeka Yovomerezeka yalembedwa pansipa:
- Ma laboratories ovomerezeka* ogwiritsira ntchito mankhwala anu ayenera kukhala ndi malipoti a zotsatira zoyezetsa, ndi Mapepala Ovomerezeka onse. Pakafunika kutero, njira zina zoyenera zofalitsira Mapepala Oonawa zingagwiritsidwe ntchito, zomwe zingaphatikizepo zoulutsira mawu.
- Ma laboratories ovomerezeka ogwiritsira ntchito mankhwala anu ayenera kugwiritsa ntchito mankhwala anu monga momwe zalembedwera pa malembo ovomerezeka. Kupatuka kumachitidwe ovomerezeka, kuphatikiza zida zovomerezeka, mitundu yovomerezeka yazachipatala, zowongolera zovomerezeka, zida zina zovomerezeka, ndi zida zovomerezeka zomwe zimafunikira kugwiritsa ntchito chinthu chanu sizololedwa.
- Ma laboratories ovomerezeka omwe amalandila malonda anu ayenera kudziwitsa oyang'anira mabungwe azaumoyo pazolinga zawo zoyendetsera malonda anu asanayambe kuyesa.
- Ma laboratories ovomerezeka omwe amagwiritsa ntchito mankhwala anu ayenera kukhala ndi njira yoti azilembera zotsatira zoyeserera kwa othandizira azaumoyo ndi oyang'anira azaumoyo, ngati kuli koyenera.
- Ma laboratories ovomerezeka ayenera kutolera zambiri za momwe mankhwala anu amagwirira ntchito ndikupereka lipoti ku DMD/OHT7-OIR/OPEQ/CDRH (kudzera pa imelo: CDRH-EUA-Reporting@fda.hhs.gov) ndi Quidel (kudzera pa imelo:
QDL.COV2.test.event.report@quidel.com, kapena kudzera pa foni polumikizana ndi Quidel Customer Support Services pa 800.874.1517 (ku US) kapena 858.552.1100) zilizonse zoganiziridwa kuti zakhala zabodza kapena zabodza komanso zopatuka kwambiri. kuchokera pamachitidwe okhazikika azinthu zanu zomwe amazidziwa. - Onse ogwiritsa ntchito mankhwala anu ayenera kukhala ophunzitsidwa moyenera pochita ndi kutanthauzira zotsatira za malonda anu, gwiritsani ntchito zida zoyenera zodzitetezera mukamagwiritsa ntchito chida ichi, ndipo gwiritsani ntchito malonda anu malinga ndi zolembedwa zovomerezeka.
- Quidel Corporation, ogawa ovomerezeka, ndi ma laboratories ovomerezeka omwe amagwiritsa ntchito malonda anu akuyenera kuwonetsetsa kuti zolemba zilizonse zokhudzana ndi EUA iyi zikusungidwa mpaka zitadziwitsidwa ndi FDA. Zolemba zotere ziyenera kuperekedwa kwa FDA kuti ziwunikenso zikafunsidwa.
NTCHITO ZA M'CHITALA
Mayeso a QuickVue SARS Antigen adafanizidwa ndi Reference Extracted EUA SARS-CoV-2 RT-PCR Assay pogwiritsa ntchito zitsanzo za nares swab zowumitsidwa komanso zatsopano zofananira zakunja.
Zaka zana limodzi ndi makumi asanu ndi limodzi mphambu zisanu ndi chimodzi (156) zofananira za nares swab zapambuyo kuchokera kwa odwala omwe akuwaganizira kuti ali ndi COVID-19 pasanathe masiku asanu chiyambireni zizindikiro adapezedwa kuchokera kumalo atatu otolera aku US. Zitsanzozi zidatumizidwa pamapaketi ozizira ku labotale ya Quidel ku Athens, Ohio. Kuyesa kwa Reference Extracted SARS-CoV-2 RT-PCR Assay kunachitika pa imodzi mwama swabs ofananira molingana ndi malangizo a chipangizocho kuti agwiritse ntchito. Makumi asanu ndi asanu ndi limodzi (56) a swabs otsala adawumitsidwa pa -70 ° C asanayesedwe ndi QuickVue SARS Antigen Test. Patsiku la QuickVue kuyesa ma swabs adasungunuka ndikuyesedwa ndi QuickVue SARS Antigen Test. Masamba zana (100) adayesedwa mwatsopano, mkati mwa maola 24 atatoleredwa, ndi QuickVue SARS Antigen Test.
Makumi atatu ndi asanu ndi atatu (38) ofananira ndi zitsanzo za nares swab zapambuyo kuchokera kwa odwala omwe akuwaganizira kuti ali ndi COVID-19 mkati mwa masiku asanu chiyambireni zizindikiro adapezedwa kuchokera ku kafukufuku wopitilira azachipatala pamalo atatu (3) a POC, awiri (2) ophunzitsidwa pang'ono. ogwira ntchito patsamba la POC. Swab imodzi idayesedwa pamalo a POC ndi QuickVue SARS Antigen Test ndi ogwira ntchito asanu ndi mmodzi ophunzitsidwa pang'ono patsiku lotolera. Ogwiritsa ntchito adangopatsidwa malangizo oyesera komanso kalozera wofulumira. Zofananira zofananira zidatumizidwa pamapaketi ozizira kupita ku labotale ya Quidel ku Athens, Ohio kukayezetsa SARS-CoV-2 RT-PCR. Kuyesa kwa Reference Extracted SARS-CoV-2 RT-PCR Assay kunachitika pazingwe zofananira molingana ndi malangizo a chipangizocho.
Gome ili m'munsili likufotokozera mwachidule za zitsanzo zatsopano (138) ndi zozizira (56)
| Kuyerekeza kwa QuickVue SARS Antigen Test ndi kuyeserera kovomerezeka kwa EUA Molecular comparator ndi zofanana.
zokopa zamkati |
|||||||||
| Mtundu wa specimen | Nambala
Kuyesedwa |
Zoona
Zabwino |
Zabodza
Zabwino |
Zoona
Zoipa |
Zabodza
Zoipa |
PPA% | NPA% | PPA 95%
CI |
NPA 95%
CI |
| Zitsanzo Zatsopano | 138 | 30 | 1 | 106 | 1 | 96.8 | 99.1 | 83.8 ku
99.4 |
94.9 ku
99.8 |
| Wozizira
Zitsanzo |
56 | 26 | 0 | 29 | 1 | 96.3 | 100 | 81.7 ku
99.3 |
88.3 ku
100 |
| Kuphatikiza
Zitsanzo |
194 | 56 | 1 | 135 | 2 | 96.6 | 99.3 | 88.3 ku
99.0 |
96.0 ku
99.9 |
NTCHITO YOPHUNZIRA
Malire Ozindikira
- Limit of Detection (LoD) ya QuickVue SARS Antigen Test idatsimikiziridwa pogwiritsa ntchito kuchepetsa kutentha kwa SARS-CoV-2 (ZeptoMetrix 0810587CFHI). Zida za ZeptoMetrix ndikukonza kwa SARS-Related Coronavirus 2 (SARS-CoV-2), kudzipatula USA-WA1/2020, yomwe idazimitsidwa ndi kutentha kwa 65 ° C kwa mphindi 30. Zinthuzo zidaperekedwa mozizira pamlingo wa 1.15 x107 TCID50/mL.
Kafukufukuyu kuti adziwe QuickVue SARS Antigen Test LoD idapangidwa kuti iwonetsere kuyesa pogwiritsa ntchito swabs mwachindunji. Mu kafukufukuyu, swab ya NP idalumikizidwa ndi pafupifupi 50-µL ya kachilombo ka HIV mu saline. Swab ya spiked idawonjezedwa ku QuickVue SARS Antigen Test extractant nthawi imodzi ndi swab ya NP yomwe ili ndi matrix a NP. Ma swabs adakonzedwa nthawi imodzi molingana ndi phukusi.
LoD idatsimikiziridwa munjira zitatu - Kuwunika kwa LoD
Kuchulukitsa ka 10 kwa kachilombo koyambitsa kutentha kunapangidwa mu saline ndikukonzedwa pa kafukufuku uliwonse monga tafotokozera pamwambapa. Ma dilutions awa adayesedwa katatu. Zotsika kwambiri zomwe zikuwonetsa 3 mwa 3 zabwino zidasankhidwa kuti mupeze mitundu ya LoD. Kutengera kuyesedwa uku, ndende yomwe idasankhidwa inali TCID50 ya 1.51 x104.
Kupeza LoD Range
Mapiritsi atatu (3) owirikiza kawiri adapangidwa ndi 1.51 x104 ndende mu saline wokonzedwa kuti afufuze momwe tafotokozera pamwambapa. Ma dilutions awa adayesedwa katatu. Zochepa kwambiri zosonyeza 3 mwa 3 zabwino zinasankhidwa kuti zitsimikizidwe za LoD. Kutengera kuyesedwa uku, ndende yosankhidwa inali 7.57 x103.
Chitsimikizo cha LoD
Kuchuluka kwa 7.57 x103 dilution kunayesedwa nthawi makumi awiri (20). Zotsatira makumi awiri (20) mwa makumi awiri (20) zinali zabwino. Kutengera kuyesedwa uku ndendeyi idatsimikiziridwa ngati TCID50 ya 7.57 x103.
Kusanthula Kuyambiranso / Kuphatikiza
Kuwunikiranso kwa ma antibodies a monoclonal omwe akulunjika ku SARS-CoV-2 mu QuickVue SARS Antigen Test adawunikidwa ndi mtundu womwe ulipo wa SAR-CoV-2 (onani tebulo pansipa).
| 2019-nCoV Strain/Isolate | Gwero/Sample Type | Kukhazikika |
| USA-WA1/2020 | ZeptoMetrix 0810587CFHI | 1.15x107 TCID50 / mL |
Cross-Reactivity
Kuphatikizika kwa ma antibodies a monoclonal omwe amagwiritsidwa ntchito pozindikira SARS-CoV-2 adawunikidwa ndikuyesa ma virus osiyanasiyana (12) ndi ma virus (16) omwe atha kuchitapo kanthu ndi QuickVue SARS Antigen Test. Chamoyo chilichonse ndi kachilomboka zidayesedwa katatu. Kuphatikizika komaliza kwa zamoyo ndi ma virus zalembedwa mu tebulo ili m'munsimu
| Cross-Reactivity/Kusokoneza kwa QuickVue SARS Antigen Test | |||||
|
Virus/Bacteria/Parasite |
Kupsyinjika |
Chitsime / Sample
mtundu |
Kukhazikika |
Zotsatira za Cross-Reactivity* |
Zotsatira zosokoneza* |
| Adenovirus | Mtundu 1 | Kudzipatula | 1 x10 pa5.53 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Kachilombo ka corona | 229e | Kudzipatula | 1 x10 pa5.10 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Cross-Reactivity/Kusokoneza kwa QuickVue SARS Antigen Test | |||||
|
Virus/Bacteria/Parasite |
Kupsyinjika |
Chitsime / Sample
mtundu |
Kukhazikika |
Zotsatira za Cross-Reactivity* |
Zotsatira zosokoneza* |
| Kachilombo ka corona | OC43 | Kudzipatula | 9.55 x10 pa5
TCID50 / mL |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Kachilombo ka corona | NL63 | Kudzipatula | 5 x10 pa3.67 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| MERS-CoV (yotsekedwa ndi kutentha) | Florida/USA- 2_Saudi
Arabia_2014 |
Kudzipatula |
1.17 x10 pa5 TCID50 / mL |
Palibe Cross-Reactivity |
Palibe Zosokoneza |
| Mycoplasma chibayo | M129 | Kudzipatula | 3 x10 pa6
CCU/mL** |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Streptococcus pyogenes | Z018 | Kudzipatula | 3.8 x10 pa6
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Fuluwenza A H3N2 | Brisbane/10/07 | Kudzipatula | 1 x10 pa5.07 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Fuluwenza A H1N1 | Chatsopano
Caledonia/20/99 |
Kudzipatula | 1 x10 pa5.66 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Fuluwenza B. | Brisbane/33/08 | Kudzipatula | 1 x10 pa5.15 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Parainfluenza | Mtundu 1 | Kudzipatula | 1 x10 pa5.01 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Parainfluenza | Mtundu 2 | Kudzipatula | 1 x10 pa5.34 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Parainfluenza | Mtundu 3 | Kudzipatula | 8.5 x10 pa5
TCID50 / mL |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Parainfluenza | mtundu 4b | Kudzipatula | 1 x10 pa5.53 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Matenda a Enterovirus | Mtundu 68 | Kudzipatula | 1 x10 pa5.5 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Munthu
Matenda a Metapneumovirus |
A1 (IA10-s003) | Kudzipatula | 1 x10 pa5.55 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Respiratory Syncytial
Kachilombo |
Mtundu A (3/2015
Kupatula #3) |
Kudzipatula | 1 x10 pa5.62 U / mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Rhinovirus yaumunthu | N / A | Osatsegulidwa
kachilombo |
Ayi
zilipo*** |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Chlamydophila
chibayo |
AR-39 | Kudzipatula | 2.9 x10 pa6
IFU/mL**** |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Hemophilus influenzae | Mtundu b; Wachikunja | Kudzipatula | 7.87 x10 pa6
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Legionella pneumophila | Philadelphia | Kudzipatula | 6.82 x10 pa6
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Streptococcus
chibayo |
Z022; 19f | Kudzipatula | 2.26 x10 pa6
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Bordetella pertussis | A639 | Kudzipatula | 6.37 x10 pa6
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Pneumocystis jirovecii-S.
alireza Recombinant |
W303-Pji |
Kudzipatula |
1.56 x10 pa6
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Mycobacterium
chifuwa chachikulu |
Gawo #: H37Ra-1 | Kudzipatula | 6.86 x10 pa7
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Staphylococcus
epidermis |
MRSE; Zamgululi | Kudzipatula | 1.21 x10 pa10
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Staphylococcus aureus
Mtengo wa MSSA |
Mtengo wa NCTC8325 | Kudzipatula | 5.5 x10 pa9
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Cross-Reactivity/Kusokoneza kwa QuickVue SARS Antigen Test | |||||
|
Virus/Bacteria/Parasite |
Kupsyinjika |
Chitsime / Sample
mtundu |
Kukhazikika |
Zotsatira za Cross-Reactivity* |
Zotsatira zosokoneza* |
| Staphylococcus aureus
MRSA |
0801638 | Kudzipatula | 1.38 x10 pa10
cfu/ml |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| Coronavirus HKU1 sanayesedwe kuti achitepo kanthu chifukwa chosowa kupezeka. Zitsanzo 19 zomwe zinali ndi Coronavirus HKU1 zidayesedwa ndipo zonse zidakhala zoipa, kuyezetsa konyowa kowonjezera sikunafunike. | |||||
- *Kuyesa kunachitika katatu
- **CCU/mL ndi Colour Change Unit monga momwe amawerengedwera molingana ndi njira yosinthidwa ya Reed-Muench kutengera kusungunuka komwe kumapangitsa kusintha kwa utoto mu msuzi.
- *** Katunduyu ali ndi kachilombo koyambitsa matenda ndipo palibe kuchuluka komwe kumaperekedwa.
- **** IFU/mL ndi mayunitsi opatsirana pa mililita
Hook Effect
Monga gawo la kafukufuku wa LoD, kuchuluka kwamafuta osagwiritsidwa ntchito ndi kutentha kwa SARS-CoV-2 komwe kunalipo (TCID50 ya 3.40 x105 pa mL) kudayesedwa. Panalibe mphamvu ya Hook yomwe yapezeka.
Zovuta Zosokoneza Zinthu Zosintha
Kafukufuku adachitika kuti awonetse kuti zinthu makumi awiri (20) zomwe zitha kusokoneza zomwe zitha kupezeka m'malo opumira apamwamba sizimadutsa kapena kusokoneza kuzindikira kwa SARS-CoV-2 mu QuickVue SARS Antigen Test.
| Zomwe Zingasokoneze Mayeso a Antigen a QuickVue SARS | ||||
| Mankhwala | Yogwira pophika | Kukhazikika | Cross-Reactivity
Zotsatira* |
Kusokoneza
Zotsatira* |
| Afrin - utsi wa m'mphuno | Oxymetazoline | 5% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Ofooketsa tizilombo (Alkalol) | Galphimia glauca, Luffa
operculate, Sabadilla |
10x | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Magazi (anthu) | Magazi | 5% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Chloraseptic, Cepacol | Benzocaine, Menthol | 0.7 g/ml | Palibe Cross-Reactivity | Palibe Zosokoneza |
| CVS spray pakhosi | Phenol | 1.4% | ||
| Flonase | Fluticasone | 5% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Halls Relief Cherry
Kukoma |
Menthol | 0.8 g/ml | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Mafuta a Mupirocin | Mupirocin | 2% w/w | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Nasacort Allergy 24
ola |
Triamcinolone | 5.00% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| NasalCrom Spray | Cromolyn Sodium | 5.2 mg | Palibe Cross-Reactivity | Palibe Zosokoneza |
| NeilMed SinuFlow
Okonzeka Muzimutsuka |
Sodium kolorayidi, sodium
bicarbonate |
Ayi
zilipo** |
Palibe Cross-Reactivity | Palibe Zosokoneza |
| NeilMed SinuFrin Plus | Oxymetazoline HCl | 0.05% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Neo-Synephrine | Phenylephrine
hydrochloride |
5% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Oseltamivir | Oseltamivir | 2.2 μg/mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Zomwe Zingasokoneze Mayeso a Antigen a QuickVue SARS | ||||
| Mapuloteni oyeretsedwa a mucin | Mucin protein | 2.5 mg/mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Rhinocort | budesonide
(Glucocorticoid) |
5% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Saline nasal spray | Saline | 15% | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Zamgululi | Zamgululi | 1.25 mg/mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Zanamivir | Zanamivir | 282.0 ng/mL | Palibe Cross-Reactivity | Palibe Zosokoneza |
| Zicam Cold Remedy | Galphimia glauca, Luffa
operculate, Sabadilla |
5% | Palibe Cross-Reactivity | Palibe Zosokoneza |
- *Kuyesa kunachitika katatu
- ** Palibe kukhazikika komwe kunaperekedwa pakulemba kwazinthu
THANDIZO
Ngati muli ndi mafunso okhudzana ndi kugwiritsa ntchito mankhwalawa, chonde imbani Nambala Yothandizira ya Quidel's 800.874.1517 (ku US) kapena 858.552.1100, Lolemba mpaka Lachisanu, kuyambira 7:00 am mpaka 5:00 pm, Pacific Time. Ngati kunja kwa US, lemberani distributor kwanuko kapena technicalsupport@quidel.com. Mavuto amachitidwe oyesera atha kunenedwanso ku FDA kudzera mu pulogalamu yofotokozera zachipatala ya MedWatch (foni:
800.FDA.1088; fax: 800.FDA.0178; http://www.fda.gov/medwatch).
MALONJE
- Baker, S., Frias, L., ndi Bendix, A. Coronavirus zosintha: Anthu opitilira 92,000 atenga kachilombo ndipo osachepera 3,100 amwalira. US yanena kuti anthu 6 afa. Nazi zonse zomwe tikudziwa. Business Insider. Marichi 03, 2020.
- https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
- Clinical ndi Laboratory Standards Institute. Viral Culture; Malangizo Ovomerezeka. Chikalata cha CLSI M41-A [ISBN 1562386239] Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2006.
- Lauer, SA, et. al. Nthawi yokulirapo ya matenda a Coronavirus 2019 (COVID-19) kuchokera pamilandu yotsimikizika pagulu: kuyerekezera ndi kugwiritsa ntchito, Ann Intern Med. 2020
- Biosafety mu Microbiological and Biomedical Laboratories, Kope lachisanu. US department of Health and Human Services, CDC, NIH, Washington, DC (5).
- Henretig FM MD, King C. MD. Buku la Pediatric Procedures, Chapter 123 - Obtaining Biologic specimens Williams ndi Williams (April 1997).
- Clinical Virology Laboratory, department of Laboratory Medicine ku Yale: http://info.med.yale.edu/labmed/virology/booklet.html.
- Mapulani a Australian Management for Pandemic Influenza - Gawo 5 Annex 5: Malangizo a Laboratory.
Zolemba / Zothandizira
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Mayeso a Antigen a QUIDEL QuickVue SARS [pdf] Buku la Malangizo QuickVue SARS Antigen Test, QuickVue, SARS, Antigen Test |
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Mayeso a Antigen a QUIDEL QuickVue SARS [pdf] Buku la Malangizo QuickVue SARS Antigen Test |
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Mayeso a Antigen a QUIDEL QuickVue SARS [pdf] Malangizo QuickVue SARS Antigen Test, QuickVue, SARS Antigen Test, Antigen Test, Test |
