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@ zybro
SARS-CoV-2 Nucleic Acid Detection Kit(PCR-Fluorescent Probe Method)
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tPrb&lct Nam.l
(s.mpL RlquiEn'€nE I
tARS-CoV-2 Nucler Acid Detecton Krt (PCR+l6re(ent Flobe Melhod) 1 Acceptable specmn3 Nasopharynqeal !wab/ O,cphairEed 5wab/ saliva
I Pa.king Specifi cationl 2 Speciren! Sampllng: Techniclant enq3ged n collecting specimens of
SARS-CoV-2 should receive biosafely lra'ning (qlalifi€d by lrairt.g) and be eniilhd
4|mI]1 321Xn wLth @responding exp€imenlal rkilh Peuonal PDtectve eqlriPrent (PPE)
' {o8olo2 96rln requtremnts. N95 markr 9o99bs, prctecnve clolhrng. latex glovee, waierproof
boorj
--IlDt rd.d ul.l I SampllrE Te<hn,ques:
SAR5-Cov-26a.iemberclrr€.o,.nawu!Bqenlt I has enveLpe .^d round or
l) Olopharyngeal !wab: Take 2 Plastic{od swabs wth PorprcPylene fber nP lo
ovalFarr,cles i6dlameter oi6! - r.!O nm ltr qenet c characleristi.s e tgnifcanllv
dlflerent from SARS-aoVand MERS-aoV Clrent relearche! rho! that il has more simlltarcoust 5eab the bilateral pharyngeal tonsih and PosterDr pharvhgealwall
rian 85% horclogy wth Bat SARSl,le corcBrrut (Bat_sL-aoVZC15) Wi€. Dp ltE ,vab trps lnro a tub€ ccntaining 3 mL lFecBren lolution (or 0.9% NaCD.
dBcard the talt and tghten the tube cap.
cuilured n vriro SARS-cov-2 ca^ be lound rn huron resP.atory ep thelElcelh in
a Nasopharyngeal swab:Genlt nle a plallc-rod swab with potpEP$ene rber
about96 houu ltcan calse iymptome su(h a5 vilalPnelmonia a.d dvsPnea
iip into nasopalatiE rn the nasal cana[ hold for a nDrent then slot, Dtale it
li€
Th6 kll r uied i. qurl atNe dete.lbn ot SARS{ov-2 RNA in Nalopharvnqeal
sab/ Oroprary^geal swab/ sallva from slsPected COVlOrg case!. t!5pected .dd take rt od Iake a planic-,od sw.b with Pol}?ropylene fb€r tiP ,nd .oiecl
tpe.'m.n iicm arctner the sam way lhmelse two twabr in the ran\e
cllnere.l case!. other @res requiring 5AR5-CoV-2 dagnots or dd{erential ^onriln
diaqnoss I can sPeof.ally deed the targel genet {N, RdFP and t geier) of lube containing I mL sp€cinEn solution (or 09% NaCl), discard the tail! and
5AR5-Cov-2 and 6 appl€d n drntra1 diagnoes oi sAR 9_Cov_2 lnlect on The telt
l) Sahva: Colect s.loa in . s.rnple collectEn tube and vorter wel
resulrs a,e on, tor clinical reierefte. rather t\an the only lta^dard to. cliNcal
4. sp€oEEnr Preparalton and Storrqe:
diagmis and t€atmnt h i! €comref.led to conducl comPehensive anarlit ol
l) sp€cnnenr shouh be collected in bios.fety cabinet of BsL-2 bboratory after
the patients' conditons in combination wth lir€ r clinrcal man fertanons and othel
labc.alory d'aqnostrc lBtults
2) A[ rpedmens lhould be stoed h iree2]n9_re.istant lpe.irlen colkion tube ol
ll€rt Pdnciplel m.*
ippopriate 5ize with gaskel in the s.lew c.P Tiglrlen th€ lid oftube and ttle
This plod(t qualiatiwly detecls 5AR5_Cov-2 RNA in the lp€.imeh llrough on€
number, $!, Mme and colL<ing date on tiE conlaner
Step R€al-Iime RI'PCR melhod The lpeomn deEcto^ plD e$ mar^t onntts
l) Seal ti€ sample ,n a phrtc bag of surlable tize Otu Plastt bag n indisdualv br
@ Itohtion .nd PrcParation
holatron and prePa'aion oi SARS{ov_2 RNA .an be condlcted manualt or n
5.spedft$ should be delected irnmediately, or nored.t 2-8iC lor no nDre th.n
5erfaut.maic or,n tull-rrnornaric insnume.ts (re lhe n!.ler &Ld e{raclion kil
24h -2cr5t lor io m,e than I monthr li a delay in etraction is.rpeded,
-nr*'a:'orr.d.., spc. rene siould be tEred al '70.c_cl , ivold,e'.etF- --
6. Speci,iens Transpct:
-
€) R!v.E. Trantcriplion aod PCR AmPltlicttbn
l) SpecinEns rhould b€ sent io t'E laboBlo.y a5 econ a! Poslible after colledion r
Applicable i.ntureiG (se lAPPlicrbL lnsuurentsl lor detailed rcdel,) is u5€d
L'ngiiitarxe liansport it erPetie<j, it reque* tul s€aled Prk slh K! bag or d'y
lo. dete.lion The 5AR5_Cov_2 RriA pePa€d rn step (D i5 €ve'se_tran,6ibed to
ice refrigeGton io Gmain temperature
generale comglementary DNA kDNA) in R'I-PCR ea.tion srlem. And Icombhet
2) P.ckaging reqlirerunts: Ihe tantPort package ol SARS_CoV_2 sl.ain or other
,tth rp€tifc primer and prcb€! (ptimers and Prcbe! ore detigmd a.cordrng to
poGntial, nledio!! bologGl mate.iak i! categonzed a! category A a'i ils
t\e .onetued requefte! ol N. RdRP and E gem, for PCR amPlftation
conerpoding UN numb€r i5 UN2814. Ihe packagirc ehorld confDrm to Plm2
Qualirative d€te.ton of SARS-CoV-2 i! reallzed by mnitodnq the ch,rge of
clasrifcanon aid packaging cquiEmentt in Iechnic.l Innrudions tor ihe Safe
ffuores.efte signal inte6ty dLri^g RT-PCR amPlircaiiorL
Idmport of Datts€out Good5 by Ar. (Doc 928a) fomulaied by lntemational Civil
UNG{UTP i! eel to minimize the Posnbil'ty ol contnm'nairn cauted by PCR
Aviatis Org.iizalbn Th€ ervrcnrenld lrrPk E crt€goized at c.tegorv Ltn
amplfcation plod(rt! duritE delecton ln lhe meauirmc wt t\€ .ombidton ol
,rr comlpondir! UN tumber it UN3373 Ih€ padaging shouH conlo'm !o P1690
human GAPDB ger€ as intemll contrcl, it can avod lake rEganve resdt in PCR
clasrifcation and packaqiog Gqulremsnts ln I{inical lnstru.tions lor $e Safe
T,anspcd of Dangerour Good! by Ar (Do< 9284) fornuhied bv lder'ationalCMl
tM.in
Avalon Orga.izatcn othe. mertr ol tr4Portalm can fo{oe qarda'd
32lAn
pxlagi.! showed above
3) Tranrportaiion tequnernents: Should b€ tlbject to nttional, federal, state, 5nd
b(-,ltraaspodalion reqdation! lorpaatog€nr.
(Apph.tlon PEG.duErI
1. NuclokA.U Ettr ction (condu.ted ln r.mPl. prcc.sciq zorr)
& (Maqrctic Bead Medrcd) MB2O]PO096) matubctuEd
Nuder a.d €xrrxtjon
lrr it hgtly lecofllmnd€d to mate ei,aciion and pcP'ration cl
by Zlbio
sAns-Cov-2 RNA. ma.p.l, temFautom.tt ari .utonrarc PDesses e ava{able
- b-pi+i alE.-J ;:^rLatrti6i'r:::
NrEL'E -d ertraction i, tmukaneoully condxl€d rd SaRs_CoV'Z NegarNe
1.rlote: Do nol (5e the teaqenls in difie€nt lots whln oe experii'ent contol and 5AR5-CCV-2 PoritiE Contrc|
2. Conlumbles €quiGd but noi pmvided nldeic ekl enract on and puflfi'ation
2. D.Ectbn C.p..ity
reagent and matclEd equiP'rPnt CentifLrge tubet 02 mL PCR lub€s (or PCR (Il (MaqBric Bead Meircd)'(Yx82018@95) manulactuGd
Nu:ler€ acid Extraction
E{lnp tubet. 96{eX plaEiI filte, lip (10 & 2m sL 1S0 uL) and other
by ZFio I!r. is uad b m.le extra.ton ard preP.ralron ol SARS<ov_2 RNA
coi5lrmibles manlalt or in seri-adomntic or tull_automatic in5truments. Sffipl€ detedton
(Stor{E .nd V.ndny) ci ditier€nt procesing method s s shcwn .t belo$/:
1. stored d -25 - -15'C bl 12 Ftonths. Potechlts Ircm diEd sun lqht
tes
;I
2. Sto,ed at: - 8rc ro, rO d;r oi.e op€ned Do mt refteeze mre tr,a 5
I IoBpo.ted ,h leahd cooler box or ltyrolo3m bor wilh dry i@ lot 7 dave
tApplkaHc lnrirulienttl
ABlTtm Real-'I r€ PcR sFlem SLAN_96P Real-Trme PCR Syttem rnd otter PcR
ryrleme with FAM, vlqHEX. ROx and CY5 channeh Allthe lnstuments, exceFl lor
I PCU Fe:q.rl PreP...l on 1(ondu.led reaqe'l treparatr'n z'qe)
Agl 75@ ReaFTme PCR 5yrreE 9LAN_96P Real_Tnle PcR syltem, reed lo be 'n
@ zybro
SARS-CoV-2 Nucleic Acid Detection Kit(PCR-Fluorescent Probe Method)
N of leagerlls Eqdr.d (N= Number ol sampler . Number ot N€gatrc Conircl . 4 Neganve Esuhs only rndi.are thrt iie sample it bekw the deteclon trmt and
Number o{ Pdirry€ Conrrcl) Prepare rhe reetion iolulion accordillg to ih€ table rnfeclon s not compleiet excluded
I Pmdud P.rforrurr. lndkitorl
I Minimum detedon lrnat 100 coprr/mL Dilul,e posilpe iamptes which are
5ARt{oV'z icR rPi.u^ s.rrhd 3 tr3.eable tod8ltal PCR b the lowelt d€tection limtt conentrarDn, and rhe pos[ ve
SAeS.Cov-2 t.r re !.r"bi 2 detedlcn rare i, :95961n:2C).
2. Ple.ision ihree emple! w,th dfferern coftenr.aton level (negat e ,arplet
Nlt ihe prep.red,ei.lc^ 5ol!lon rid centafug: I ior selefrrlsecoids lr..iler la .rrlkal poerde samph! and moderare pcltive ramDlet) ke tesled lor 12 lmes
ut oi sclll on nto each PCR rea.to. lub€, th Iller i ps. ransrer lhem ro simple wililin:l dar. E&h sample wa5 tened with I EplGtes, .M the results all Nr $€
test reruhe of iegatNe lampler were allegative lhe ten rcsuhs ot c.rlral posirive
4. sa.nple prcp.tuU {condu.r.d in r.mpl€ p.o(ersing zom) samples *€r€ all pc!!!e The coettk6nt of vaiaticn o, Cr lcr ole ren resulrs oi
Add respeclNely l0 pL oi nuclelc rLd limple. SARS-C.V-2 Negauve Contr.l and moderate poeirive sampl* $/as lers than 5%.
SARS-CoV-2 Poln€ Contrcl,.!o ea.h PCR.e{l!o.lub! wi:t, ilte. ipr. ard coler I Speofictyr Pid,ers and prcbee oi d1le p^rducl are dertged bared on
the caps, th€n trans.ler them tc rie
ampl'fi.ar'6n detectio. zo"!:fler trr^senr .onseruative re96r ol S RS<oV-2 gercm.. lt ihdl.ct have cros! re&tion with
<ent.fuqrllon to avcd produc.,t b'rbbler ntubes oelel respialcry comnavnls.s {N163, Nn l, 229t, OCrl). tARs-CoV MERS{oV
5. PCRAmpliftation O.le.tioh (corduct d in amplifrcation detection zom) Infl!€nzaA Vlru!, lnfl@nza B virlr, nelp ratory Srrvual Vr!s. Adenovnus.
Plr reactDn lu.Er,.t. illo.elce^t PCq,n3.iuhe.t dnd r.co'c r5e r!-be
PCR P.rainflEn2a Vru' KEtsiela pnelMve Sueptaeof.ut p1e!6onEe
3^d sequencecllhe s.mplr,.nd let PCR;mpllc ofFar3treter!Lp15.liwl . H*roph,to! hfLen2a Pretdaaldas dng,nca. leg{,wta p.,afiofu*,
the table belcw {rike AB 75r,0,or erample): peftutst Saaphyloco..ut auleu| M),todasma pneunata a d
Eordetella
Chtahtdg pheunotua
(Wamirlgr.nd Pr..aurbnll
1 Th s prodlrt isont 6ed ior in vitro diagnosis, pleate lead drs m. ual caren t
bebre use, and it tr lcr prcfe$ionaluse oi,
2 Clintal hboratorcr thould 9lrrtt lclow Ure ,r1egere^t r.gut.rioB o{
rcle<ular bElogy l.boaroriee and clini.at gem amplncato^ t.bo.arorEe n
Mear(e! ior i\e Managem€nt cJ Clin@l Ger,€ Amplilicaricn Labo.aioriee in
I Op€raton 5rould have knoeledge of mobcula. bobgl..t det ction o.9€t
lraining tor PcR sk,lls
- r+.irFporrtre_cirrfibt9iaut -sllgltEnrrirnkrEo!-ibjt;i€!-1.lrn!3rqad
Retul$ alE .domakally ,&ed after the rea.1@ft shiL rarget curver and
cofletpor'd'ng inlehal (.dard curves are analyzed sepa..te, Stari latue, End
teati.nt F6t ret dte requr€nEnG o{,elevanl regulatEns
5. Alter tllc eiperiment all !h. used insnlmnt! and €qupnEnt musr be tre.ted
vall.€, and Tkelhold lalLre of Barelii€ are adjlned .ccording l! anatzed image
(e9 SLan value lang€ 3 - 15, €NO value ..n9€ 5 - 20) and m.ke amplifrcario. wlth ffi hypo.hlorour &id or 70% etharcl \d W lamps. Dr.aded rjps mln be
cw€ ol the mgalLE conlrDl nri*lht or b.lo, th. threthou line. Oi:k iAnatyze' lc dispos€d ln *i'G ta^ts conraitorg t0% l1ypcrbrcus acil to prtvenr
obtain anatrir.esLtu a')d nake param€teE meer th€ requ rcrEnrs in '7. Ouatily
6. Prcd'r.l pe.formaEe har ont ben @dfed wnh the sample typer ,nd
ConlDl PrcceduE bebw tt*n re.o.d ttE derectio. reslrls rn .Plate, window
po.ersng m€thod! 6enliorl.d abole The pfDdl{l pe Omance *ith othe.
Z Qu.lit C.nbol Procldur.
iahpl,E typs or smple cole.tion .nd poce$rB mtMd! cairrct gwanced.
lR.f.r.nc.il i
1A Novel Ccrcne,r.rs ,rom PatEntJ *ith Pneumoni. in Crina. New E^ql.nd
lounal ol MedrirE, Zhu N, ZhaE O W..g w. et al. 2020, 382i8).
2. Guidel,rc, on diagrcti5 and n€atrrEnt oI SARS-CoV-2 {eighrh editlo.). Bureau
ot Oire.re Conlrol ad Preventjon rn Narion.l Hedrh Ccmm,rsk)n ot TtE psptc,i
Reptdk ol China 2020.
{rei i.i,.ilr r,.L: i.-r l 3. Etol,ogy and Pllv.nrion ol A.tne R€sprarory Vrtur tnf.ctbn. Chrta UnDn
Medi..l UniveEity Prers. lku Yunde, 20C5.
Lrgel ch.rEl, ol IAr4 lox ri cYs & d.&.ted, th. mpttt rs 4 SeatTidE ft-rp5.enr PCR lechnotogy {5€.ord .ditD.l) sci€Ee pBr, Li
p6h. @to6 re tp.rl s.rEped:,td.r Ls16*1c! <rto, 9R5<ov-2 Rr*\ R delecJ6 lndry.2016
and r@ons .s p6(E 5 Muhphx Ed-tme PCR 16r deledicn of r€rprarory rrrt lrcctons. tomar ot
faM .ieln N g.^., ROX mlotB ndRp 9a. Cyt idi:b! € g.re ert ,6uh. Gini.d Vrrclog)a Bnnan-Lonq R, Nord s, Otolrron t et d .Zo0e, olrl S:-so.
E$t nOX .tri CYS ,lFB.!@ clEnElt .!e .ot d.i.crd d Cl . aS. ..1 lc dxx * Ex
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Floor I to Floo l. Bu&ng 10, rlc 6 oi Trta.g Road, Bb.t C of li.rq,& rndBtnat
Pa*, Dadukou D6trEt. Chongq'ng. ChDa {01082
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