QUIDEL QuickVue SARS Antigen Test Instruction Manual

QuickVue SARS Antigen Test yog ib qho lateral flow immunoassay uas tso cai rau kev tshawb nrhiav sai, zoo ntawm nucleocapsid protein antigen los ntawm SARS-CoV-2 hauv anterior nares (NS) swab specimens ncaj qha los ntawm cov tib neeg uas xav tias yog COVID-19 los ntawm lawv cov kev kho mob. tus kws kho mob hauv thawj tsib hnub ntawm qhov pib tshwm sim. Kev ntsuam xyuas tsuas yog txwv rau cov chaw soj nstuam uas tau lees paub raws li Kev Tshawb Fawb Kev Txhim Kho Kev Kho Mob ntawm 1988 (CLIA), 42 USC §263a, uas ua tau raws li qhov yuav tsum tau ua kom muaj kev sim ntsuas nruab nrab, siab, lossis zam tsis yooj yim. Qhov kev ntsuam xyuas no tau tso cai siv rau ntawm Point of Care (POC), piv txwv li, cov chaw saib xyuas neeg mob hauv tsev kho mob ua haujlwm raws li CLIA Certificate of Waiver, Certificate of Compliance, lossis Certificate of Accreditation. QuickVue SARS Antigen test tsis txawv ntawm SARS-CoV thiab SARS-CoV-2. Cov txiaj ntsig yog rau kev txheeb xyuas ntawm SARS-CoV-2 nucleocapsid protein antigen. Cov antigen feem ntau pom tau nyob rau hauv anterior nares specimens thaum lub sij hawm mob hnyav. Cov txiaj ntsig zoo qhia tau hais tias muaj cov kab mob antigens, tab sis kev sib raug zoo nrog cov neeg mob keeb kwm thiab lwm cov ntaub ntawv kuaj mob yog tsim nyog los txiav txim seb tus kab mob. Cov txiaj ntsig zoo tsis txwv kev kis kab mob lossis kev sib koom ua ke nrog lwm cov kab mob. Tus neeg sawv cev kuaj pom yuav tsis yog qhov tseeb ntawm tus kab mob. Cov chaw kuaj mob hauv Tebchaws Meskas thiab nws thaj chaw yuav tsum tau tshaj tawm tag nrho cov txiaj ntsig mus rau tsoomfwv saib xyuas kev noj qab haus huv uas tsim nyog. Cov txiaj ntsig tsis zoo yuav tsum raug kho raws li qhov xav tau thiab kev pom zoo nrog kev tshuaj ntsuam xyuas molecular, yog tias tsim nyog, rau kev tswj tus neeg mob, tuaj yeem ua tiav. Cov txiaj ntsig tsis zoo tsis txiav txim siab txog COVID-19 thiab yuav tsum tsis txhob siv los ua lub hauv paus rau kev kho mob lossis kev txiav txim siab tswj tus neeg mob, suav nrog kev txiav txim siab tswj kev kis kab mob. Cov txiaj ntsig tsis zoo yuav tsum raug txiav txim siab hauv cov ntsiab lus ntawm tus neeg mob qhov tshwm sim tsis ntev los no, keeb kwm, thiab muaj cov tsos mob tshwm sim thiab cov tsos mob zoo ib yam nrog COVID-19. QuickVue SARS Antigen test yog npaj rau kev siv los ntawm cov kws kho mob hauv chaw kuaj mob thiab cov tib neeg uas tau kawm hauv qhov chaw saib xyuas. QuickVue SARS Antigen test tsuas yog siv rau hauv Food and Drug Administration's Emergency Use Authorization.

SUMMARY THIAB EXPLANATION

SARS-CoV-2, tseem hu ua tus kab mob COVID-19, tau pom thawj zaug hauv Wuhan, Hubei Xeev, Tuam Tshoj thaum lub Kaum Ob Hlis 2019. Tus kab mob no, ib yam li tus kabmob tshiab SARS-1 thiab MERS, xav tias muaj keeb kwm ntawm puav. Txawm li cas los xij, SARS-CoV-2 tej zaum yuav muaj tus neeg nruab nrab xws li pangolins, thiab npua, lossis civets.1 Lub koom haum WHO tau tshaj tawm tias COVID-19 yog tus kabmob kis rau lub Peb Hlis 11, 2020, thiab tib neeg kis tau mus thoob ntiaj teb, nrog Ntau pua txhiab tus neeg paub tseeb tias muaj tus kab mob thiab tuag.2 Lub sijhawm nruab nrab ntawm kev kis kab mob yog kwv yees li 5.1 hnub nrog cov tsos mob xav tias yuav muaj nyob rau hauv 12 hnub ntawm kev kis tus kab mob.3 Cov tsos mob ntawm COVID-19 zoo ib yam li lwm cov kab mob ua pa thiab suav nrog ua npaws, hnoos, thiab ua tsis taus pa.4

TXOJ CAI NTAWM LUB txheej txheem

QuickVue SARS Antigen test siv cov cuab yeej siv tshuaj tiv thaiv kab mob sib kis. Siv qhov kev sim no tso cai rau kev tshawb pom sai ntawm nucleocapsid protein los ntawm SARS-CoV thiab SARS-CoV-2. Qhov kev sim no tso cai rau kev tshawb pom ntawm SARS-CoV thiab SARS-CoV-2 tab sis tsis sib txawv ntawm ob tus kab mob.
Txhawm rau pib qhov kev sim, lyophilized reagent yuav tsum tau rov ua dej hauv Reagent Tube. Cov tshuaj reagent no ua kom yooj yim nthuav tawm cov tshuaj tiv thaiv kab mob tsim nyog rau cov tshuaj tiv thaiv kab mob uas siv hauv kev sim. Cov Reagent yog thawj zaug rov ua dej nrog cov tshuaj Reagent muab, thiab cov qauv swab tau muab tso rau hauv Reagent Tube. Cov Reagent no cuam tshuam nrog cov qauv thiab ua kom yooj yim nthuav tawm cov kab mob sib kis uas tsim nyog rau cov tshuaj tiv thaiv uas siv hauv kev sim. Test Strip yog ntxiv rau Reagent Tube tam sim no muaj cov qauv thiab cov tshuaj Reagent.
Yog hais tias cov qauv muab rho tawm muaj SARS-CoV lossis SARS-CoV-2 antigens, kab liab-rau-liab Test Line, nrog rau cov txheej txheem xiav xiav yuav tshwm sim ntawm Test Strip qhia tau tias muaj txiaj ntsig zoo. Yog tias tsis muaj SARS-CoV lossis SARS-CoV-2 los yog tam sim no nyob rau theem qis heev, tsuas yog cov txheej txheem xiav xiav yuav tshwm sim.

REAGENTS THIAB KHOOM PLIG

25-Test Kit

Ib tus neeg ntim khoom kuaj kab (25): Monoclonal anti-SARS cov tshuaj tiv thaiv
Reagent Tubes (25): Lyophilized buffer nrog detergents thiab txo cov neeg ua haujlwm
Reagent Solution (25): Vials nrog 340 μL ntsev tov
Sterile Nasal Swabs (Kit #20387) (25)
SARS Positive Control Swab (1): Swab yog coated nrog non-infectious recombinant SARS antigens

Kev tswj tsis zoo Swab (1): Swab yog coated nrog cov cua sov-inactivated, tsis muaj kab mob Streptococcus C antigen
Pob Ntxig (1)
Tus Txheej Txheem Daim Ntawv (1)

Cov khoom siv tsis yog khoom siv

Timer lossis saib
QuickVue SARS Antigen Control Swab Teeb rau QC ntxiv (20389)

Dry transport tube (SKU #20385) (25). Khaws ntawm chav tsev kub.

CEEB TOOM THIAB KEV TIV THAIV

Rau hauv vitro diagnostic siv
Rau kev siv tshuaj xwb
Cov khoom no tsis tau FDA tshem tawm lossis pom zoo; tab sis tau raug tso cai los ntawm FDA raws li Kev Tso Cai Siv Thaum Muaj Xwm Ceev (EUA) rau kev siv los ntawm cov chaw soj nstuam tau lees paub raws li CLIA uas ua tau raws li qhov yuav tsum tau ua kom muaj kev sim ntsuas nruab nrab, siab, lossis zam tsis yooj yim. Cov khoom no tau tso cai siv rau ntawm Point of Care (POC), piv txwv li, cov chaw saib xyuas neeg mob hauv chaw ua haujlwm raws li CLIA Daim Ntawv Pov Thawj Kev Zam, Daim Ntawv Pov Thawj Ua Raws Cai, lossis Daim Ntawv Pov Thawj Kev lees paub.

Cov khoom no tau tso cai tsuas yog kuaj pom cov protein los ntawm SARS-CoV-2, tsis yog rau lwm yam kab mob lossis kab mob kis.
Qhov kev sim no tsuas yog tso cai rau lub sijhawm tshaj tawm tias muaj xwm txheej tshwm sim ua pov thawj rau kev tso cai siv thaum muaj xwm txheej ceev hauv vitro kuaj kev kuaj pom thiab / lossis kev kuaj mob ntawm COVID-19 raws li Tshooj 564(b)(1) ntawm Txoj Cai, 21 USC § 360bbb-3(b)(1) tshwj tsis yog tias kev tso cai raug txiav los yog tshem tawm sai dua.

Tsis txhob siv cov khoom siv ntim dhau lub hnub tas sij hawm uas luam tawm sab nraum lub thawv.
Hnav cov khaub ncaws tiv thaiv tsim nyog, hnab looj tes (nitrile lossis latex), thiab tiv thaiv qhov muag / ntsej muag thaum tuav tus neeg mob.amples los yog siv cov khoom siv.

Cov tshuaj Reagent muaj cov tshuaj ntsev (saline). Yog tias cov tshuaj tiv thaiv daim tawv nqaij lossis qhov muag, yaug nrog dej ntau ntau.
Tsis txhob rov qab siv cov Test Sawb, Reagent Tubes, kev daws teeb meem, lossis Tswj Swabs.

Test Strip yuav tsum tau muab kaw rau hauv lub hnab ntawv tiv thaiv kom txog thaum siv. Tus neeg siv yuav tsum tsis txhob qhib lub hnab ntawv ntawm Test Strip nthuav tawm nws mus rau qhov chaw ib puag ncig kom txog rau thaum Test Strip yog npaj rau kev siv tam sim. Yog tias daim ntawv xeem qhib rau ib teev lossis ntev dua, cov txiaj ntsig tsis raug cai yuav tshwm sim.
QuickVue SARS Antigen Test yuav tsum tsuas yog siv nrog cov lyophilized tsis thiab cov tshuaj reagent muab rau hauv cov khoom siv.

Kev sau cov qauv zoo, khaws cia, thiab thauj khoom yog qhov tseem ceeb rau kev ua haujlwm ntawm qhov kev sim no. Nrhiav kev cob qhia tshwj xeeb lossis kev taw qhia yog tias koj tsis tau ntsib nrog kev sau thiab tuav cov txheej txheem.5,6,7,8
Thaum khaws cov nasal swab sample, siv lub qhov ntswg swab muab rau hauv cov khoom siv (Kit #20387)

Kev sau cov qauv tsis zoo lossis tsis tsim nyog, khaws cia, thiab kev thauj mus los yuav ua rau cov txiaj ntsig tsis zoo-tsis zoo.
Yuav kom tau txais cov txiaj ntsig raug, koj yuav tsum ua raws li Cov Lus Qhia Ntxiv Pob.

Cov tib neeg uas muaj xim tsis pom kev tuaj yeem tsis tuaj yeem txhais cov txiaj ntsig tau zoo.
Kev ntsuam xyuas yuav tsum tau ua nyob rau hauv ib qho chaw uas muaj cua txaus.

Pov tseg cov thawv ntim khoom thiab cov khoom siv tsis siv raws li Tsoom Fwv Teb Chaws, Lub Xeev, thiab Cov Cai Tswj Xyuas Hauv Zos.
Ntxuav tes kom huv si tom qab tuav.
Yog xav paub ntxiv txog kev nyab xeeb, tuav, thiab pov tseg ntawm cov khoom siv hauv cov khoom siv no, thov xa mus rau Daim Ntawv Qhia Txog Kev Nyab Xeeb (SDS) nyob ntawm quidel.com.

COV KHOOM SIV KHW THIAB NYAB LAJ

Khaws cov khoom siv ntawm chav sov, 59 ° F txog 86 ° F (15 ° C txog 30 ° C), tawm ntawm tshav ntuj ncaj qha. Cov ntsiab lus ntawm cov khoom siv ruaj khov kom txog rau thaum hnub tas sij hawm luam tawm ntawm lub thawv sab nrauv. Tsis txhob khov.
TSHWJ XEEB KOOM THIAB TUAJ YEEM
Kev sau cov qauv thiab kev tuav tau zoo yog qhov tseem ceeb rau kev ua tau zoo ntawm qhov kev sim no.5,6,7,8 Cov Qauv Sau Nasal Swab Sample

Siv lub qhov ntswg swab muab rau hauv cov khoom siv.
Ua ntej khaws lub qhov ntswg qhov ntswg, tus neeg mob yuav tsum tau qhia kom tshuab qhov ntswg. Mus khaws tau nasal swab sample, ntxig tag nrho cov ntxiab ntxiab ntawm lub swab (feem ntau ½ mus rau ¾ ntawm ib nti (1 mus rau 1.5 cm) hauv qhov ntswg thiab khov kho s.ample ntawm phab ntsa ntawm qhov ntswg los ntawm kev tig lub swab nyob rau hauv ib ncig ntawm lub qhov ntswg phab ntsa yam tsawg kawg yog 4 zaug. Siv sijhawm li 15 vib nas this los sau cov sample. Nco ntsoov sau tej qhov ntswg qhov ntswg uas yuav muaj nyob rau ntawm lub swab.
Sample ob lub qhov ntswg nrog tib lub swab.
Sample Transport thiab Storage Samples yuav tsum tau kuaj kom sai li sai tau tom qab sau. Raws li cov ntaub ntawv tsim los nrog QuickVue SARS Antigen Test, qhov ntswg swabs ruaj khov mus txog 120-teev ntawm chav tsev kub lossis 2 ° txog 8 ° C hauv lub raj xa dej huv thiab qhuav.

QUALITY CONTROL

Muaj ob hom kev Tswj Xyuas Zoo rau cov cuab yeej no: cov yam ntxwv ntawm kev tswj hwm tau teev tseg hauv qab no thiab kev tswj hwm sab nraud.

Built-in Control Nta

QuickVue SARS Antigen test muaj cov txheej txheem tswj kev ua haujlwm. Cov chaw tsim khoom pom zoo rau kev tswj hwm txhua hnub yog sau cov txheej txheem tsim ua hauv thawj sample sim txhua hnub.
Cov txiaj ntsig ob xim muab cov ntsiab lus yooj yim ntawm cov txiaj ntsig zoo thiab tsis zoo. Qhov tshwm sim ntawm cov txheej txheem xiav xiav tswj kab muab kev tswj xyuas zoo los ntawm kev ua kom txaus txaus tau tshwm sim thiab kev ua haujlwm ncaj ncees ntawm Test Strip tau khaws cia. Yog tias cov txheej txheem xiav xiav tsis tsim nyob rau hauv 10 feeb ntawm Test Strip, ces qhov kev xeem tsis raug.
Kev tswj tsis zoo hauv built-in yog muab los ntawm kev tshem tawm cov xim liab tom qab, xyuas kom meej tias qhov kev sim tau ua tiav lawm. Tsis pub dhau 10 feeb, qhov tshwm sim ntawm thaj chaw yuav tsum yog dawb mus rau lub teeb liab liab thiab tso cai rau kev txhais lus meej ntawm qhov kev xeem. Yog tias cov xim tom qab tseem nyob thiab cuam tshuam nrog kev txhais cov txiaj ntsig ntawm qhov kev xeem, ces qhov kev xeem tsis raug. Yog tias qhov no tshwm sim, review txheej txheem thiab rov ua qhov kev sim nrog tus neeg mob tshiab sample thiab Test Sawb tshiab. Nws yog ib qho tsim nyog los sau lwm tus neeg mob tus qauv; Tus neeg mob swabs lossis reagents tsis tuaj yeem rov qab siv dua.

Kev Tswj Zoo Sab Nraud

Cov Kev Tswj Sab Nraud kuj tseem siv tau los ua kom pom tias cov tshuaj reagents thiab cov txheej txheem tshuaj xyuas ua tau zoo.
Quidel pom zoo tias kev tswj xyuas qhov zoo thiab qhov tsis zoo yuav tsum tau ua ib zaug rau txhua tus neeg ua haujlwm tsis tau txais kev cob qhia, ib zaug rau txhua qhov kev xa khoom tshiab ntawm cov khoom siv - muab tias txhua qhov sib txawv tau txais hauv cov khoom xa tuaj raug kuaj - thiab raws li qhov xav tau ntxiv los ntawm koj cov txheej txheem tswj kev ua haujlwm zoo, thiab ua raws. nrog rau hauv zos, xeev thiab tsoom fwv cov cai los yog kev lees paub yuav tsum tau.
Cov txheej txheem xeem uas tau piav qhia hauv Pob Pob yuav tsum tau siv thaum kuaj cov kev tswj xyuas sab nraud.
Yog tias kev tswj hwm tsis ua raws li qhov xav tau, rov ua qhov kev sim lossis hu rau Quidel Technical Support ua ntej kuaj cov neeg mob.
Ntxiv Kev Tswj Swabs tuaj yeem tau sib cais los ntawm kev hu rau Quidel Cov Kev Pabcuam Cov Neeg Siv Khoom ntawm (800) 874.1517 (hu dawb hauv Tebchaws Meskas) lossis (858) 552.1100.

KEV KAWM NTAWV

Cov ntaub ntawv xeem thiab cov qauv kuaj mob yuav tsum nyob hauv chav sov ua ntej pib qhov kev xeem.
Hnub tas sij hawm: Tshawb xyuas tas sij hawm ntawm txhua tus neeg kuaj pob lossis lub thawv sab nrauv ua ntej siv. Tsis txhob siv ib qho kev xeem dhau hnub tas sij hawm ntawm daim ntawv lo.

Nasal Swab Test Procedure

Ntxiv cov tshuaj Reagent mus rau Reagent Tube. Maj mam swirl lub raj kom yaj nws cov ntsiab lus.
Lub Reagent Tube yuav tsum nyob twj ywm hauv lub raj yas kom tag nrho ntawm kev sim.
Tam sim ntawd tso tus neeg mob swab sampnyob rau hauv lub Reagent Tube. Yob lub swab yam tsawg kawg ntawm peb (3) zaug thaum nias lub taub hau tawm tsam hauv qab thiab sab ntawm Reagent Tube.
Khaws lub swab rau hauv lub raj rau ib (1) feeb.
Cov txiaj ntsig tsis raug lossis tsis raug yuav tshwm sim yog tias lub sijhawm incubation luv dhau lossis ntev dhau.
Qhia tag nrho cov kua los ntawm lub taub hau swab los ntawm dov lub swab yam tsawg kawg ntawm peb (3) zaug thaum lub swab raug tshem tawm. Muab pov tseg lub swab raws li koj cov txheej txheem pov tseg biohazard pov tseg.
Muab qhov Test strip rau hauv Reagent Tube nrog cov xub taw rau hauv qab. Tsis txhob kov lossis txav mus rau Test Strip kom txog thaum qhov kev xeem tiav thiab npaj rau kev nyeem ntawv.
Thaum kaum (10) feeb, tshem qhov Test strip, thiab nyeem qhov tshwm sim nyob rau hauv tsib (5) feeb raws li Kev Tshaj Tawm Txog Kev Tshawb Fawb.
Test strips yuav tsum tau nyeem ntawm 10-thiab 15 feeb tom qab muab tso rau hauv Reagent Tube. False-positive, cuav tsis zoo, lossis cov txiaj ntsig tsis raug tuaj yeem tshwm sim yog tias lub strip tau nyeem dhau lub sijhawm pom zoo.

Kev txhais cov ntsiab lus

Cov txiaj ntsig zoo*:
Thaum kaum (10) feeb, qhov tshwm sim ntawm txhua qhov ntxoov ntxoo ntawm kab liab-rau-liab Test Kab THIAB qhov pom ntawm xiav txheej txheem tswj kab qhia tau tias muaj txiaj ntsig zoo rau qhov muaj SARS antigen. Cov txiaj ntsig yuav nyob ruaj khov rau tsib (5) feeb tom qab lub sijhawm nyeem ntawv pom zoo. Tsis txhob nyeem qhov tshwm sim ntau tshaj kaum tsib feeb tom qab muab tso rau hauv Reagent Tube.
* Cov txiaj ntsig zoo tsis txwv kev sib koom ua ke nrog lwm cov kab mob.
∗ Saib ze ze! Qhov no yog qhov txiaj ntsig zoo. Txawm hais tias koj pom qhov tsaus muag heev, liab kab Test Kab thiab xiav Tswj Kab, koj yuav tsum qhia qhov tshwm sim zoo li POSITIVE.
C = Tswj Kab
T = Test Kab

Cov txiaj ntsig tsis zoo**:

Thaum kaum (10) feeb, qhov tsos ntawm Tsuas yog cov txheej txheem xiav xiav qhia tias tsis pom SARS antigen. Cov txiaj ntsig yuav nyob ruaj khov rau tsib (5) feeb tom qab lub sijhawm nyeem ntawv pom zoo. Tsis txhob nyeem qhov tshwm sim ntau tshaj kaum tsib feeb tom qab muab tso rau hauv Reagent Tube.
** Cov txiaj ntsig tsis zoo tsis suav nrog tus kab mob SARS-CoV-2. Cov txiaj ntsig tsis zoo yuav tsum raug kho raws li qhov xav tau thiab yuav tsum tau lees paub nrog kev ntsuas molecular.

Tsis Yog

Yog tias thaum kaum (10) feeb, cov txheej txheem xiav xiav tsis tshwm sim, txawm tias ib qho ntxoov ntxoo ntawm kab liab-rau-liab Test Kab tshwm, qhov tshwm sim tsis raug.
Yog tias thaum kaum (10) feeb, cov xim tom qab tsis meej thiab nws cuam tshuam nrog kev nyeem ntawv ntawm qhov kev xeem, qhov tshwm sim kuj tsis raug.

Yog tias qhov tshwm sim tsis raug, kev sim tshiab yuav tsum tau ua nrog tus neeg mob tshiab sample thiab Test Sawb tshiab.

TXOJ CAI

Qhov kev sim no yog npaj rau cov qauv swab ncaj nraim nkaus xwb. Viral Transport Media (VTM) yuav tsum tsis txhob siv nrog qhov kev sim no vim nws yuav ua rau cov txiaj ntsig tsis raug.
Cov ntsiab lus ntawm cov khoom siv no tsuas yog siv rau kev kuaj pom zoo ntawm SARS antigens los ntawm anterior nares nasal swab specimens.

Cov txiaj ntsig tsis zoo yuav tshwm sim yog tias qib ntawm antigen hauv liample yog qis dua qhov kev kuaj pom ntawm qhov kev sim lossis yog tias sample tau sau tsis raug.
Qhov kev ntsuas no kuaj pom ob qhov siv tau (nyob) thiab tsis muaj peev xwm, SARS-CoV, thiab SARS-CoV-2. Kev sim ua tau zoo nyob ntawm seb muaj pes tsawg tus kab mob (antigen) hauv sample thiab tej zaum yuav los yog tsis cuam tshuam nrog kab lis kev cai cov txiaj ntsig tau ua rau tib lub sample.
Kev ua tsis tau raws li Cov Txheej Txheem Kev Xeem thiab Kev txhais cov txiaj ntsig yuav ua rau muaj kev cuam tshuam tsis zoo rau kev xeem thiab / lossis ua tsis raug rau Kev Xeem Xeem.

Cov Txiaj Ntsim Kuaj yuav tsum tau muab coj los ntsuas ua ke nrog lwm cov ntaub ntawv tshuaj muaj rau tus kws kho mob.
Cov kev kuaj pom tsis zoo tsis yog tswj hwm rau lwm yam tsis-SARS kis lossis kab mob.
Cov txiaj ntsig zoo tsis txwv kev sib koom ua ke nrog lwm cov kab mob.

Cov txiaj ntsig tsis zoo yuav tsum raug kho raws li qhov xav tau, thiab kev pom zoo nrog kev tshuaj ntsuam xyuas molecular, yog tias tsim nyog rau kev tswj tus neeg mob, tuaj yeem ua tiav.
Yog tias qhov sib txawv ntawm SARS cov kab mob tshwj xeeb thiab kab mob uas xav tau, kev tshuaj xyuas ntxiv, hauv kev sab laj nrog xeev lossis cheeb tsam kev noj qab haus huv hauv zej zog, yuav tsum ua.

COV TSEV KAWM NTAWV TSEEM CEEB RAU LUB LABORATORY THIAB KEV KHO MOB

Daim ntawv tso cai QuickVue SARS Antigen Test, nrog rau daim ntawv tso cai rau cov kws kho mob, daim ntawv tso cai rau cov neeg mob, thiab daim ntawv tso cai muaj nyob rau ntawm FDA. webqhov chaw: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
Txawm li cas los xij, txhawm rau pab cov chaw soj ntsuam kuaj mob siv QuickVue SARS Antigen Test ("koj cov khoom" hauv cov xwm txheej hauv qab no), cov xwm txheej cuam tshuam ntawm Kev Tso Cai tau teev tseg hauv qab no:
Cov chaw soj ntsuam tau tso cai * siv koj cov khoom yuav tsum suav nrog cov ntaub ntawv xeem, thiab tag nrho cov ntawv pov thawj pom zoo. Raws li qhov xwm txheej tshwm sim, lwm txoj hauv kev tsim nyog rau kev tshaj tawm Cov Ntawv Teev Tseg no yuav raug siv, uas yuav suav nrog cov xov xwm loj.

Cov chaw soj ntsuam tso cai siv koj cov khoom yuav tsum siv koj cov khoom raws li tau teev tseg hauv daim ntawv tso cai. Kev sib txawv los ntawm cov txheej txheem kev tso cai, suav nrog cov cuab yeej tso cai, cov qauv kuaj mob tau tso cai, cov ntaub ntawv tswj hwm tau tso cai, tso cai rau lwm cov khoom siv ntxiv, thiab cov ntaub ntawv tso cai yuav tsum siv koj cov khoom tsis tso cai.
Tso cai cov chaw soj nstuam uas tau txais koj cov khoom yuav tsum ceeb toom cov tub ceev xwm saib xyuas kev noj qab haus huv txog lawv lub hom phiaj los tswj koj cov khoom ua ntej pib sim.
Lub chaw soj ntsuam tso cai siv koj cov khoom yuav tsum muaj tus txheej txheem nyob rau hauv qhov chaw tshaj tawm cov ntawv kuaj mob rau cov kws kho mob thiab cov tub ceev xwm noj qab haus huv uas tsim nyog, raws li tsim nyog.

Cov chaw soj ntsuam tau tso cai yuav tsum sau cov ntaub ntawv hais txog kev ua tau zoo ntawm koj cov khoom thiab qhia rau DMD/OHT7-OIR/OPEQ/CDRH (ntawm email: CDRH-EUA-Reporting@fda.hhs.gov) thiab Quidel (ntawm email:
QDL.COV2.test.event.report@quidel.com, los yog hauv xov tooj los ntawm kev tiv tauj Quidel Customer Support Services ntawm 800.874.1517 (hauv Teb Chaws Asmeskas) lossis 858.552.1100) ib qho kev xav tias qhov tshwm sim ntawm qhov tsis zoo lossis qhov tsis zoo tsis zoo thiab qhov sib txawv tseem ceeb los ntawm kev tsim cov yam ntxwv ntawm koj cov khoom uas lawv paub txog.
Txhua tus neeg tsav tsheb uas siv koj cov khoom yuav tsum muaj kev cob qhia tsim nyog hauv kev ua thiab txhais cov txiaj ntsig ntawm koj cov khoom, siv cov khoom tiv thaiv tus kheej tsim nyog thaum tuav cov khoom siv no, thiab siv koj cov khoom lag luam raws li daim ntawv tso cai pom zoo.
Quidel Corporation, cov chaw tsim khoom tau tso cai, thiab cov chaw kuaj pom muaj cai siv koj cov khoom yuav tsum xyuas kom meej tias cov ntaub ntawv cuam tshuam nrog EUA no raug khaws cia kom txog thaum FDA ceeb toom lwm yam. Cov ntaub ntawv zoo li no yuav tsum muaj rau FDA rau kev tshuaj xyuas thaum thov.

KAWM TAU TXUJ CI

Lub QuickVue SARS Antigen Test tau muab piv rau Kev Tshawb Fawb Extracted EUA SARS-CoV-2 RT-PCR Assay siv khov thiab tshiab matched anterior nares swab specimens.
Ib puas tsib caug-rau-rau (156) tau sib tw anterior nares swab specimens los ntawm cov neeg mob xav tias muaj COVID-19 nyob rau hauv tsib hnub ntawm cov tsos mob tshwm sim tau los ntawm peb qhov chaw sau npe hauv Asmeskas. Cov qauv raug xa mus rau cov pob khoom txias rau Quidel lub chaw kuaj mob hauv Athens, Ohio. Qhov Kev Tshawb Fawb Tshaj Tawm SARS-CoV-2 RT-PCR Assay kuaj tau ua tiav ntawm ib qho ntawm cov swabs sib xws raws li lub cuab yeej cov lus qhia rau kev siv. Tsib caug rau (56) ntawm qhov seem swabs tau khov ntawm -70 ° C ua ntej kev sim nrog QuickVue SARS Antigen Test. Hnub ntawm QuickVue kuaj cov swabs tau thawed thiab sim nrog QuickVue SARS Antigen Test. Ib puas (100) swabs tau sim tshiab, tsis pub dhau 24-teev ntawm kev sau, nrog rau QuickVue SARS Antigen Test.

Peb caug-yim (38) tau sib tw anterior nares swab cov qauv los ntawm cov neeg mob uas xav tias muaj COVID-19 nyob rau hauv tsib hnub ntawm cov tsos mob tshwm sim tau los ntawm kev tshawb fawb soj ntsuam txuas ntxiv ntawm peb (3) POC qhov chaw, nrog ob (2) kev kawm tsawg tsawg cov neeg ua haujlwm ntawm POC site. Ib lub swab tau sim ntawm POC qhov chaw nrog QuickVue SARS Antigen Test los ntawm rau tus neeg ua haujlwm tsawg kawg nkaus rau hnub sau. Cov neeg ua haujlwm tsuas yog muab cov lus qhia xeem thiab cov lus qhia ceev ceev. Cov swabs sib txuam tau raug xa mus rau cov pob khoom txias rau Quidel lub chaw kuaj mob hauv Athens, Ohio rau kev kuaj SARS-CoV-2 RT-PCR. Qhov Kev Tshawb Fawb Extracted SARS-CoV-2 RT-PCR Assay test tau ua nyob rau ntawm qhov sib txuam swabs raws li lub cuab yeej cov lus qhia rau kev siv.

Cov lus hauv qab no qhia txog cov ntaub ntawv los ntawm cov tshiab (138) thiab khov (56) cov qauv

Kev sib piv ntawm QuickVue SARS Antigen Test thiab ib qho kev tso cai EUA Molecular kev sib piv nrog rau kev sib piv anterior nares swabs
Yam Yam Ntxim Saib Ntxim Ua	Tus lej Kuaj	Muaj tseeb Qhov zoo	cuav Qhov zoo	Muaj tseeb Tsis zoo	cuav Tsis zoo	PPA%	NPA%	PPA 95% CI	NPA 95% CI
Cov Qauv Tshiab	138	30	1	106	1	96.8	99.1	83.8 rau 99.4	94.9 rau 99.8
Khov Cov qauv	56	26	0	29	1	96.3	100	81.7 rau 99.3	88.3 rau 100
Ua ke Cov qauv	194	56	1	135	2	96.6	99.3	88.3 rau 99.0	96.0 rau 99.9

KEV TSO CAI TSIS TXAUS

Txwv Kev Tshawb Nrhiav

Qhov Limit of Detection (LoD) ntawm QuickVue SARS Antigen Test tau txiav txim siab los ntawm kev txwv cov dilutions ntawm tshav kub-inactivated SARS-CoV-2 (ZeptoMetrix 0810587CFHI). Cov khoom siv ZeptoMetrix yog ib qho kev npaj ntawm SARS-Related Coronavirus 2 (SARS-CoV-2), cais USA-WA1/2020, uas tau ua tsis tau los ntawm cua sov ntawm 65 ° C rau 30-feeb. Cov khoom tau muab khov rau ntawm qhov concentration ntawm 1.15 x107 TCID50 / mL.
Txoj kev tshawb nrhiav los txiav txim siab QuickVue SARS Antigen Test LoD tau tsim los cuam tshuam qhov kev ntsuam xyuas thaum siv cov swabs ncaj qha. Hauv qhov kev tshawb fawb no, NP swab tau spiked nrog kwv yees li 50-µL ntawm tus kab mob dilution hauv saline. Lub spiked swab tau ntxiv rau QuickVue SARS Antigen Test extractant concurrently rau NP swab uas muaj NP matrix. Cov swabs tau ua tiav concurrently raws li lub pob ntxig.
LoD tau txiav txim siab hauv peb kauj ruam
Kev Ntsuam Xyuas LoD
10-fold dilutions ntawm tus kab mob tshav kub-inactivated tau ua nyob rau hauv saline thiab ua tiav rau txhua txoj kev tshawb fawb raws li tau piav qhia saum toj no. Cov dilutions no tau sim hauv triplicate. Qhov qis tshaj plaws qhia pom 3 ntawm 3 qhov zoo tau raug xaiv rau LoD ntau yam kev tshawb nrhiav. Raws li qhov kev ntsuam xyuas no, qhov concentration xaiv yog TCID50 ntawm 1.51 x104.
LoD Range Nrhiav
Peb (3) ob npaug dilutions tau ua los ntawm 1.51 x104 concentration hauv saline ua tiav rau txoj kev tshawb no raws li tau piav qhia saum toj no. Cov dilutions no tau sim hauv triplicate. Qhov qis tshaj plaws qhia pom 3 ntawm 3 qhov zoo tau raug xaiv rau LoD kev pom zoo. Raws li qhov kev ntsuas no, qhov concentration tau xaiv yog 7.57 x103.
LoD kev lees paub
Qhov concentration ntawm 7.57 x103 dilution tau sim nees nkaum (20) zaug. Nees nkaum (20) ntawm nees nkaum (20) cov txiaj ntsig tau zoo. Raws li qhov kev ntsuas no, qhov concentration tau lees paub tias yog TCID50 ntawm 7.57 x103.

Kev Tshawb Fawb Kev Tshaj Tawm/suav nrog
Kev tshuaj ntsuam xyuas ntawm cov tshuaj tiv thaiv monoclonal tsom rau SARS-CoV-2 hauv QuickVue SARS Antigen Test tau raug soj ntsuam nrog tam sim no muaj SAR-CoV-2 strain (saib cov lus hauv qab).

2019-nCoV Strain/Isolate	Tau qhov twg los/Sample Type	Nco ntsoov
USA-WA1/2020	ZeptoMetrix 0810587CFHI	1.15 10xXNUMX⁷ TSO 50/ml

Hla-Reactivity

Hla-reactivity ntawm monoclonal antibodies siv rau kev kuaj pom ntawm SARS-CoV-2 tau soj ntsuam los ntawm kev sim ntau yam kab mob (12) thiab kab mob (16) uas tuaj yeem cuam tshuam nrog QuickVue SARS Antigen Test. Txhua kab mob thiab kab mob tau sim hauv triplicate. Qhov kawg concentration ntawm cov kab mob thiab cov kab mob yog sau tseg nyob rau hauv cov lus hauv qab no

Hla-Reactivity/Interference ntawm QuickVue SARS Antigen Test
Virus/Bacteria/Parasite	Lim	Qhov chaw / Sample hom	Nco ntsoov	Hla-Reactivity Results*	Cov txiaj ntsig cuam tshuam *
Adenovirus	npe 1	cais tawm	1 x 10^5.53 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Khau laus nas vais lav	229 ua e	cais tawm	1 x 10^5.10 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam

Hla-Reactivity/Interference ntawm QuickVue SARS Antigen Test
Virus/Bacteria/Parasite	Lim	Qhov chaw / Sample hom	Nco ntsoov	Hla-Reactivity Results*	Cov txiaj ntsig cuam tshuam *
Khau laus nas vais lav	TSI 43	cais tawm	9.55 x 10⁵ TSO 50/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Khau laus nas vais lav	NL63	cais tawm	5 x 10^3.67 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
MERS-CoV (heat-inactivated)	Florida/USA- 2_Saudi Arabia_2014	cais tawm	1.17 x 10⁵ TSO 50/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Mycoplasma pneumoniae	M129	cais tawm	3 x 10⁶ CCU/ml **	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Streptococcus pyogenes muaj	z018 ua	cais tawm	3.8 x 10⁶ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tus mob khaub thuas A H3N2	Brisbane/10/07/XNUMX	cais tawm	1 x 10^5.07 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tus mob khaub thuas A H1N1	Tshiab Caledonia/20/99/	cais tawm	1 x 10^5.66 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tus mob khaub thuas B	Brisbane/33/08/XNUMX	cais tawm	1 x 10^5.15 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Parainfluenza	npe 1	cais tawm	1 x 10^5.01 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Parainfluenza	npe 2	cais tawm	1 x 10^5.34 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Parainfluenza	npe 3	cais tawm	8.5 x 10⁵ TSO 50/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Parainfluenza	typ 4 b	cais tawm	1 x 10^5.53 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Enterovirus	npe 68	cais tawm	1 x 10^5.5 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tib neeg Metapneumovirus	A1 (IA10-S003)	cais tawm	1 x 10^5.55 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Ua pa Syncytial Kab mob vais lav	Hom A (3/2015 cais #3)	cais tawm	1 x 10^5.62 UA/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tib neeg Rhinovirus	N/A	Inactivated kab mob vais lav	Tsis yog muaj ***	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Chlamydophila mob ntsws	TIAB SA-39	cais tawm	2.9 x 10⁶ IFU/ml ****	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Hemophilus influenzae	Hom b; Eagan	cais tawm	7.87 x 10⁶ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Legionella pneumophila	Philadelphia	cais tawm	6.82 x 10⁶ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Streptococcus mob ntsws	Z022; 19f ib	cais tawm	2.26 x 10⁶ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Bordetella pertussis	A639	cais tawm	6.37 x 10⁶ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Pneumocystis jirovecii-S. cerevisiae Recombinant	W 303-Pji	cais tawm	1.56 x 10⁶ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Mycobacterium tuberculosis	H37Ra-1	cais tawm	6.86 x 10⁷ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Staphylococcus epidermis	MRSE; RP62A	cais tawm	1.21 x 10¹⁰ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Staphylococcus aureus MSSA	TIAB SA 8325	cais tawm	5.5 x 10⁹ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam

Hla-Reactivity/Interference ntawm QuickVue SARS Antigen Test
Virus/Bacteria/Parasite	Lim	Qhov chaw / Sample hom	Nco ntsoov	Hla-Reactivity Results*	Cov txiaj ntsig cuam tshuam *
Staphylococcus aureus MRSA	0801638	cais tawm	1.38 x 10¹⁰ cfu/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tus mob Coronavirus HKU1 tsis tau kuaj pom qhov cuam tshuam vim tsis muaj. 19 tus qauv uas muaj tus mob Coronavirus HKU1 tau raug sim thiab txhua yam ua rau tsis zoo, tsis tas yuav tsum muaj kev kuaj dej sib txawv ntxiv.

* Kev sim tau ua hauv triplicate
**CCU/mL yog Xim Hloov Chaw raws li xam raws li kev hloov kho Reed-Muench raws li dilutions uas ua rau muaj xim hloov hauv cov kua zaub.
*** Cov Tshuag yog inactivated virus uas tsis muaj quantitation muab.

**** IFU / mL yog kis kab mob ib milliliter

Hook Effect

Raws li ib feem ntawm txoj kev tshawb fawb LoD, qhov siab tshaj plaws ntawm cov khoom siv hluav taws xob tsis ua haujlwm SARS-CoV-2 muaj (TCID50 ntawm 3.40 x105 ib mL) tau sim. Tsis muaj Hook effect kuaj pom.

Endogenous Interference Substances Studies

Ib txoj kev tshawb fawb tau ua los ua pov thawj tias nees nkaum (20) muaj peev xwm cuam tshuam cov tshuaj uas tuaj yeem pom nyob rau hauv lub ntsws sab sauv tsis cuam tshuam los yog cuam tshuam nrog kev tshawb pom ntawm SARS-CoV-2 hauv QuickVue SARS Antigen Test.

Muaj peev xwm cuam tshuam cov tshuaj rau QuickVue SARS Antigen Test
Tshuaj	Cov khoom xyaw nquag	Nco ntsoov	Hla-Reactivity Cov txiaj ntsig *	Kev cuam tshuam Cov txiaj ntsig *
Afrin - tshuaj tsuag qhov ntswg	Oxymetazoline	5%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Homeopathic (Alkalol)	Galphimia glauca, Luffa operculate, Sabadilla	10x ib	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Ntshav (neeg)	Ntshav	5%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Chloraseptic, Cepacol	Benzocaine, Menthol	0.7 g / mL	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
CVS caj pas tsuag	Phenol	1.4%
Flonase	Fluticasone	5%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Halls Relief Cherry Flavour	Menthol	0.8 g / mL	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Mupirocin Ointment	Mupirocin	2% w/w	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Nasacort Allergy 24 teev	Triamcinolone	5.00%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
NasalCrom Spray	Cromolyn sodium	5.2 mg XNUMX	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
NeilMed SinuFlow Npaj yaug	Sodium chloride, sodium ntsev bicarbonate	Tsis yog muaj**	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
NeilMed SinuFrin Plus	Oxymetazoline HCl	0.05%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Neo-Synephrine	Phenylephrine hydrochloride	5%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Oseltamivir	Oseltamivir	2.2 µg/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam

Muaj peev xwm cuam tshuam cov tshuaj rau QuickVue SARS Antigen Test
Purified mucin protein ntau	Mucin protein	2.5 mg/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Rhinocort	Budesonide (Glucocorticoid)	5%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tshuaj tsuag qhov ntswg	Saline	15%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Tshuaj Tobramycin	Tshuaj Tobramycin	1.25 mg/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Zanamivir	Zanamivir	282.0 ng/ml	Tsis muaj Cross-Reactivity	Tsis cuam tshuam
Zicam Kev Kho Mob Txias	Galphimia glauca, Luffa operculate, Sabadilla	5%	Tsis muaj Cross-Reactivity	Tsis cuam tshuam

* Kev sim tau ua hauv triplicate
** Tsis muaj concentration tau muab nyob rau hauv cov khoom labeling

ASSISTANCE

Yog tias koj muaj lus nug txog kev siv cov khoom no, thov hu rau Quidel's Technical Support Number 800.874.1517 (hauv Tebchaws Meskas) lossis 858.552.1100, Monday txog Friday, thaum 7:00 teev sawv ntxov txog 5:00 teev tsaus ntuj, Pacific Time. Yog tias sab nraum Teb Chaws Asmeskas, tiv tauj koj tus neeg muag khoom hauv zos lossis technicalsupport@quidel.com. Cov teeb meem kuaj kab mob kuj tseem tuaj yeem raug tshaj tawm rau FDA los ntawm MedWatch cov khoom kho mob qhia txog kev pab cuam (xov tooj:
800.FDA.1088; fax: 800.FDA.0178; http://www.fda.gov/medwatch).

REFERENCES

Baker, S., Frias, L., thiab Bendix, A. Coronavirus nyob hloov tshiab: Ntau tshaj 92,000 tus neeg tau kis tus kab mob thiab tsawg kawg 3,100 tus neeg tau tuag. Tebchaws Asmeskas tau tshaj tawm 6 tus neeg tuag. Nov yog txhua yam peb paub. Kev Lag Luam Insider. Peb Hlis 03, 2020.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
Clinical and Laboratory Standards Institute. Kab lis kev cai; Pom zoo Cov Lus Qhia. CLSI document 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. al. Lub sijhawm incubation ntawm tus kab mob Coronavirus 2019 (COVID-19) los ntawm kev tshaj tawm cov neeg mob uas tau lees paub: kev kwv yees thiab daim ntawv thov, Ann Intern Med. 2020

Biosafety hauv Microbiological thiab Biomedical Laboratories, 5 Lub Cim. Asmeskas Chaw Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg, CDC, NIH, Washington, DC (2007).
Henretig FM MD, King C. MD. Phau Ntawv Qhia Txog Kev Kho Menyuam Yaus, Tshooj 123 – Tau Txais Cov Qauv Uas Muaj Biologic Williams thiab Williams (Lub Plaub Hlis 1997).
Clinical virology Laboratory, Chav Haujlwm Kuaj Tshuaj ntawm Yale: http://info.med.yale.edu/labmed/virology/booklet.html.

Australian Management Plan for Pandemic Influenza – Seem 5 Annex 5: Laboratory Guidelines.

Cov ntaub ntawv / Cov ntaub ntawv

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	QUIDEL QuickVue SARS Antigen Test [ua pdf] Phau ntawv qhia QuickVue SARS Antigen Test
	QUIDEL QuickVue SARS Antigen Test [ua pdf] Cov lus qhia QuickVue SARS Antigen Test, QuickVue, SARS Antigen Test, Antigen Test, Test