SGTI-FLEX COVID-19 Ag
COVID-19RAPIDAgTEST
WhyCOVID-19RAPIDAgTEST?
TheCOVID-19pandemicisacceleratingaroundtheworld.Havingonlyavery
limitednumberofcountriesmanagingtoflattenthecurve,thenumberofcasesin
mostpartsoftheglobehascontinuedtoreachnewheights.
ThestandarddiagnosisforCOVID-19-moleculartest(RT-PCR)hasmany
limitations,includinghowtime-consumingitcanbe,anditsrequirementofspecific
equipmentandpersonneltraining.Thisresultsindifficultieswhensettingthe
diagnosis,andanincreasedoverallcost.
Themajoradvantageofusingantigentestingliesinreducingtheburdenofrelying
onjustRT-PCRtoidentifycurrentinfectionofSARS-CoV-2.Antigentestingis
usefulbecause(evenwhenlesssensitive)itisrapid,convenientandefficient–
assuringthattheresultswhichturnoutpositive,areindeed,positive.
ProtoPharma • 2
SGTI-FLEXCOVID-19Agisaonestep,graphic,immunochromatographicassayfora
qualitativedetectionofspecificantigenstoSARS-CoV-2presentinthehuman
nasopharynx.
Accuracy(overallagreement) 96.71%(235/243,95%CI:93:64%~98.32%)
Sensitivity(positivepercentagreement) 95.10%(136/143,95%CI:90.24%~97.61%)
Specificity(negativepercentagreement) 99%(99/100,95%CI:94.55%~99.82%)
LOD(limitofdetection)
5.3x10
2
TCID
50
/mL
[SARS-CoV2virus(ATCC,VR-1986HK2019nCoV/USAWA1/2020)]
§ Onestep,quickresults(~20min)
§ Comprehensivepackage:
-Noneedforadditionaltools/devices
§ Specimen:Nasopharyngealswap
§ Packagingincludes:25tests
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TEST ELISA DIAGNOSTIC RT-PCR ANTIGEN RAPID
SAMPLE INPUT
Serum or plasma sample
Nasopharyngeal (NP)or
Oropharyngeal (OP) swab sample
Nasopharyngeal (NP)or
Oropharyngeal (OP) swab sample
RESULT OUTPUT
DetectionoflgM/lgGorRBDlgG
antibodies,viacolorimetricassay
Detectionofviral SARS-CoV-2 RNA
viacDNAsequencing
DetectionofSARS-CoV-2-Antigenviacolor
changeofstripinlateralflowassay
STRENGTHS
Robust detection of seroconversion statusin
alaboratorysetting,candetectlgM/lgGhighly
accuratelyseveral days after onsetorsooner
Gold-standarddiagnostictest,directly detects
viruspresence(sequencingviralnucleicacids),
mostaccurate results early indisease
presentation
Very low relative cost,canbeperformedatthe
point-of-care,easytouse,fastresults,5-8min,
detectionofantigensinthesame time window
asRT-PCRtest
LIMITATIONS
Requiresrigoroustestingforcross-reactivity
withotherimmunereactions,requireslaboratory
setting
Laborintensive,requiresnumerous
additional reagentsandspecialized
equipment,canlose accuracyafter~5days
sincesymptomonset,sensitivetosample
collection error
Testspecificityandsensitivityslightlybelowthe
RT-PCRtest,multipleretestsrecommendedwill
leadtosignificantincreaseintestspecificityand
sensitivity
LABORATORY NEEDED
YES YES NO
RESULTS IN
20min 2h 15-20min
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SUGENTECHSGTi-flexCovid-19Ag:Comparativeanalysis
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SUGENTECHSGTi-flexCovid-19Ag:Comparativeanalysis
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SUGENTECHSGTi-flexCovid-19Ag:Comparativeanalysis
§ Thesamplestestedfromeachoftheproducersmayhavedifferent CT values*, meaningshouldthetestedsamples’CTvalueswerelower,thantheproductsensitivitywillbehigher(andviceversa).Therefore,a
simplecomparisonontheclaimedproductsensitivitycannotbeaccurate,However,comparingtheLOD(limitofdetection)canbeconsideredanaccurateparameter.
§ СТ (cycle threshold) isdefinedbythenumberofcyclesneededforthePCRfluorescentsignaltocrossthethreshold.LowerCTvaluesareassociatedwithhigherviralculturepositivity.
SUGENTECHSGTi-flexCovid-19Ag:Certificates
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ProtoPharma • 8
COVID-19RAPIDAgTEST
Howtouse?
1. Samplecollection
2. Sampleextraction
3. Assemblingthedroppingcap
4. Sampleanalysis
5. Resultsinterpretation
§ Clickonthevideoformoredetailedresults
§ Clickheretoreadtheuserinfoleaflet
§ ManufacturerofIn-Vitro-Diagnostics&AntigenCovid
Review:SUGENTECH,RepublicofKorea
§ IVDCEConformity,ListedatBfArM,Germany(German
PharmaceuticalInstitute)
§ ENISO9001:2015,ENISO13485:2012,GMPProduction,
EUROPEANUnionCEMark
§ Extensiveexperienceintheproductionofinvitrodiagnostic
§ ProtopharmaEngineeringGmbHGermanrepresentationfor
EU,CEE,WesternBalkans,Russiaandothers
§ CurrentlyplacedonthemarketsoftheEUcountries,Brazil,
Colombia,Russia,Vietnam,Thailand,Taiwan,Japan,Middle
East,andCroatia.
ProtoPharma • 9
CONTACTPERSON
MIROSLAVSAVANOVIC
ManagingDirector,ProtoPharmaEngineeringGmbH
+4961722790916
miroslav.savanovic@protopharma.de
www.protopharma.de
Hessenring107,61348BadHomburgv.d.H.Germany
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