RADI COVID-19 Detection Kit - Aslm
RADI COVID-19 Detection KitFOR INTERNAL USE ONLY. NOT FOR PRINT ORDISTRIBUTION1
AgendaAbout KH Medical Co. ltdAbout RADI COVID-19 Detection KIT1.Introduction2.Procedure of Diagnostics3.Diagnostic Kit Components4.Prepare qPCR Mixture5.Result Analysis6.Product Performance FINDAbout RADI PREP Swab and Stool DNA/RNA .Training andmaintenance support2
SARS-COV-2 RNA(single-stranded RNA) Sequence length : 29,990 base pairs Genes : orf1ab, S, orf3a, E, M, orf6, orf7a, orf8, N, orf10RADI COVID-19 Detection KIT Detection of S gene and RdRP gene( Orf1 gene) Product Design : Compared SARS-COV-2 and otherCorona viruses for homology. Under 75% of homology gene were selected3
RADI COVID-19 Detection KIT Test Procedure(KH Medical provide Total Solution for COVID-19 Detection:From Extraction to PCR)RADI mini cycler,16, or96RADI CYCLERRADI PREP-PLUSour TAT of 80 minutes andtest up to 576 samples ifusing the RADI 96 in an 8hrshift4
RADI COVID-19 Detection KIT5
Diagnostic KIT ComponentsKit Contents1Kit 100 Tests6
Compatible Real Time PCR Machines RADI Cyclers (mini, 16 and 96) CFX96 Real-Time PCR Detection System, Bio-rad Applied Biosystems 7500 Real-Time PCR System, ThermoFisher Rotor-Gene Q, QIAGEN LightCycler 480 System, RocheCFX96ABI 7500Rotor-Gene QLightCycler 4807
Prepare qPCR MixtureFOR INTERNAL USE ONLY. NOT FOR PRINT ORDISTRIBUTION8
Prepare qPCR Mixture1) Prepare the mixture for Real-time PCR reaction in the order below.NoMaterialVolume/Reaction13X Master Mix10ul2Primer & Probe Mixture5ul3Template (Sample, PC or NC)15ulTotal30ulPCR Mixture* Calculate the PCR mixture amount like below:Volume/Reaction * N(Samples PC NC 1)2) Aliquot 15ul of reaction mixture in each tube.3) Add 15ul each of 1 negative control, 1 Positive control and number of preparedsamples(Extracted RNA) into each tube.4) Run On PCR Machine.9
Result AnalysisS (FAM)IPC (ROX)RdRP (VIC)The threshold is 1/20 of maximum delta Rn.※ Threshold can be set up differently depending on the machine touse.10
Result 1 40 40 40Positive2 40 40ㅡPositive3 40ㅡ 40Positive4 40ㅡㅡPositive5ㅡ 40 40Positive6ㅡ 40ㅡPositive7ㅡㅡ 40Negative8ㅡㅡㅡInvalid940 4540 45 40Invalid1040 45ㅡ 40Invalid11ㅡ40 45for internal 40use only. not for printorInvaliddistribution* No reaction of IPC :Due to high concentration ofRNA, dNTP is consumed forreaction.* No sample(RNA) is added* Reaction after 40Ct : Rerun11
FOR INTERNAL USE ONLY. NOT FOR PRINT ORDISTRIBUTION12
Product -eval-molecular/)S13
Product Evaluation - ResultsRV008 RADI COVID-19 Detection Kit; LOT V008.20020214
Certification CE IVD ISO 13485:2016 ANVISA Kenya PPB FDA EUA pending WHO EUAL Pending Tanzania TMDA pending15
About RADI PREP Swab and stool DNA/RNA KIT(Manual KIT)What is a RADI PREP Swab and stool DNA/RNA KITThe RADI PREP Swab and Stool DNA / RNA KIT is a reagent used to extract nucleic acidsfrom bacteria and viruses present in samples collected from, human feces,nasopharyngeal swab, Oropharyngeal swab, sputum. The method applied to thisproduct is the Silica-(spin)Column based extraction methodBoth manual and automated method can be used. We recommend use of automated method16
Extraction kit componentsAdd 30mL of Absolute Ethanol before use.Add 48mL of Absolute Ethanol before use.3 Should be stored at 2 8 after reception.1217
Performance dataComparison of recoveryWe conducted a comparison test of RADI PREP and Qiagen recommended for use byCDC.Material of test-Specimen : Negative Nasopharyngeal swab, Synthetic COVID19 RNA(100 copies/ul)Prep Kit : RADI PREP Swab and Stool DNA/RNA KIT(MP002), QIAamp Viral RNA mini KitPCR Kit : RADI COVID-19 Detection KIT(RV008)Instrument : Table top Centrifuge, CFX96Method of test-Specimen : Follow instruction for use of RADI PREP Swab and Stool DNA/RNA KIT andQIAamp Viral RNA Mini Kit18
Performance data1000 copies/rxnKit nameRADI PREPAverageCV(%)Ct value Kit name Ct 1CV(%)0.8629.2228.7929.140.83500 copies/rxnKit nameRADI PREPAverageCV(%)Ct value Kit name Ct .04CV(%)0.4130.6430.7530.900.86Conclusion-RADI PREP and QIAamp have equivalent performance.19
Fully Automated Extractor Extraction time: 15 Minutes Weight :18 Kg Battery Charged Fully Automated Extractor Samples : Swab , Stool, Blood ,dried blood spots etc Thru put : 8 Samples (One hour: 24 32 samples ) Cost effectivenessfor internal use only. not for print ordistribution20
New Product – POCT PCR(Including Extraction and PCR ) Spec : Only 4 KgTime to result: 40 minutesEasy extraction and PCR16 Samples per runTarget Gene : E gene and S genefor COVID-19 Launching soon !21
THANK YOU22
- Prep Kit : RADI PREP Swab and Stool DNA/RNA KIT(MP002), QIAamp Viral RNA mini Kit - PCR Kit : RADI COVID-19 Detection KIT(RV008) - Instrument : Table top Centrifuge, CFX96. Method of test - Specimen : Follow instruction for use of RADI PREP Swab and Stool DNA/RNA KIT and
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UMDNS-Code: [13914] 1pc transport medium sampling tube PP 10ml with 3ml VTM liquid 1pc nasal flocked swab Sterile pack 04NSWK-02-PP10MLVTM-KIT. GenePro COVID-19 Detection Test kit One-Step Real-time RT-PCR Test CV001 - GenePo r COVID-19 Detection Test - 100 tests/kit. Transportation Tracking:
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