Biosearch Technologies SARS-CoV-2 Real-Time And End-Point .
Instructionsfor useBiosearch Technologies SARS-CoV-2Real-Time and End-Point RT-PCR TestValidation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestContentsIntended use Summary and explanation of test Special instrument requirements Principles of the procedure Reagents and materials Control material(s) to be used with Biosearch Technologies SARS-CoV-2 Real-Time andEnd-Point RT-PCR Test Warnings and precautions Sample collection, handling, and storage Instructions for use Minimize the risk of contamination oKtopure-IntelliQube SARS-CoV-2 detection workflow Interpretation of results Performance evaluation Analytical sensitivity Inclusivity (analytical sensitivity) Cross-reactivity (analytical specificity) Clinical evaluation 2333457810101010343939404041Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestIntended useThe Biosearch Technologies SAR-CoV-2 Real-Time and End-Point RT-PCR Test, manufactured by LGC,Biosearch Technologies , is a reverse transcriptase (RT)-polymerase chain reaction (PCR) test intendedfor the qualitative detection of nucleic acids from SARS‑CoV‑2 upper respiratory specimens collected fromindividuals suspected of COVID‑19 by their healthcare provider. Testing is limited to laboratories certifiedunder the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet therequirements to perform high complexity tests.Results are for the identification of SARS-CoV-2 RNA which is generally detected in respiratory specimensduring the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA;clinical correlation with patient history and other diagnostic information is necessary to determine patientinfection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Theagent detected may not be the definite cause of disease. Laboratories within the United States and itsterritories are required to report all positive results to the appropriate public health authorities.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for thepatient management decisions. Negative results must be combined with clinical observations, patient historyand epidemiological information.The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test is intended for use byqualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time orend-point PCR and in vitro diagnostic procedures. The Biosearch Technologies SARS-CoV-2 Real-Timeand End-Point RT-PCR Test is only for use under the Food and Drug Administration’s Emergency UseAuthorization (EUA).Validation of this test has not been reviewed by FDA. Review under the EUA program is pending.Summary and explanation of testSpecial instrument requirementsThe Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR test is to be used with theBiosearch Technologies oKtopure and IntelliQube instruments.The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test is a molecular in vitrodiagnostic test that is based on the widely used nucleic acid amplification technology. The BiosearchTechnologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test contains primers and probes andinternal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upperrespiratory specimens.3The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test is a reverse transcriptionpolymerase chain reaction (RT-PCR) test. The SARS-CoV-2 primer and probe set(s) are designed to detectRNA from the SARS-CoV-2 in upper respiratory specimens from patients suspected of COVID-19 by theirhealthcare provider.Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestPrinciples of the procedureNucleic acids are isolated and purified from upper respiratory specimens using the Biosearch TechnologiesoKtopure in combination with sbeadex viral RNA purification kits. The sbeadex viral RNA purificationchemistry uses a magnetic bead-based approach to purify the viral RNA from 200 µL of swab specimenwith a final elution volume of 50 µL. Using a one-step RT-PCR approach, the viral RNA template isconverted to cDNA and subsequently amplified in either the IntelliQube PCR System (real-time workflow)or in the Hydrocycler2 (end-point workflow) following dispense of 0.8 µL of assay mix containingRapiDxFire qPCR Master Mix, EpiScript RNase H- Reverse Transcriptase, SuperROX , and BHQ Probes and primers. In the process, the probe anneals to a specific target sequence located between theforward and reverse primers. During the extension phase of the PCR cycle, the 5’ nuclease activity of Taqpolymerase degrades the probe, causing the reporter dye to separate from the quencher dye, generatinga fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respectiveprobes, increasing the fluorescence intensity. Fluorescence intensity is monitored either at each PCR cycleor at end-point by the IntelliQube PCR System.4Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestReagents and materialsComponentSourceDescriptionoKtopure tipsKBS-0010-00396-tips per tray, 200 µL, box of 10 traysoKtopure filtersKBS-09-MS027oKtopure mandrel filters, 100 filters/packKBS-7001-04496-well deep-well plate, 2 mL well volume, 50 plates per boxKBS-7001-03196-well deep-well plate, 2 mL well volume, 50 plates per boxKBS-7001-13096-well deep-well plate, 1.2 mL well volume, 50 plates per boxKBS-7001-139384-well plate, 120 µl well volume, 100 plates per boxKBS-7001-132384-well plate, 100 µl well volume, 50 plates per boxKBS-7001-133384-well plate, 200 µl well volume, 50 plates per boxLysis plate sealKBS-0606-002Adhesive PCR film, 135 mm 80 mm, 100 sheets per boxElution and assay plate sealKBS-0600-002Adhesive PCR foil seal, 135 mm 80 mm, 100 sheets per boxRNA purification kitNAP40-028-04sbeadex viral RNA kit, 200 µl sample input, 10,000 purificationsNAP30-002-02Protease solution, 20 mg/mL, 10 mLNAP30-002-03Protease solution, 20 mg/mL, 100 mL0505-0211AccuPlex SARS-CoV2 full genome with RNaseP referencematerial, 6 1.76 mL tubes per boxAX843799384-tips per tray, 10 µLAX840999384-tips per tray, 40 µLAXIT384-13WP050384-well Array Tape, 2 50 array reelsAXIT768-13WP050768-well Array Tape, 2 50 array reelsAX8591CVRTIntelliQube cover seal, 350 seals rollN1RNP-10102019 nCoV N1/RnP Blend -100X Stock, 1,010 µLN2RNP-10102019 nCoV N2/RnP Blend -100X Stock, 1,010 µL30050-1RapiDxFire qPCR 5X Master Mix GF, 1 mL30050-2RapiDxFire qPCR 5X Master Mix GF, 10 mL30050-100MLRapiDxFire qPCR 5X Master Mix GF, 100 mLERT12925K-ENZEpiscript RNase H- Reverse Transcriptase, 200 U/µL,0.125 mLERT12925K-1.25Episcript RNase H- Reverse Transcriptase, 200 U/µL, 1.25 mLERT12925K-12MLEpiscript RNase H- Reverse Transcriptase, 200 U/µL, 12 mLSR-1000-1SuperROX, 15 µM, 1 mLSR-1000-10SuperROX, 15 µM, 10 mLWaste collection plateLysis and MagMix plateElution and PCR sampleplateProtease solutionPositive controlIntelliQube sample pipette tipsArray Tape Cover seal for Array TapePCR assay – oligo blends5X Master MixReverse TranscriptasePassive reference dyeTable 1. Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test – Consumables.5Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestComponentSourceDescriptionAutomation forRNA purificationKBS-0009-001oKtopure – high-throughput nucleic acid purification robotRNA purificationreagent reservoirKBS-09-050Maxi buffer reservoirKBS-0009-006Standard buffer reservoiroKtopure tip blocksKBS-09-127192-hole tip blocks for the oKtopureHandheld barcode scannerKBS-0025-003Various vendorsHandheld, USB linear barcode scannerPCR automationAXDS-0002-100IntelliQube integrated inline liquid handling,assay processing and analytical systemBulk thermal cycling(end-point only)KBS-0028-001Hydrocycler2KBS-0099-10175 L ovenKBS-0099-10240 L ovenVarious vendorsForced convection laboratory oven capable of reaching 95 ºCSoftware/data analysisUgenTec FastFinder AnalysisV4.0 And Assay Plugin “LGCEUA-SARS-CoV-2-RT v1.0”UgenTec Software – FastFinder 4.0 withAssay Plugin Real-Time – 1.0Software/data analysisUgenTec FastFinder AnalysisV4.0 And Assay Plugin “LGCEUA-SARS-CoV-2-EP v1.0”UgenTec Software – FastFinder 4.0 withAssay Plugin End-Point – 1.0PCR reagent diluent and NTCVarious vendorsMolecular or PCR grade waterAssay tubesThermoFisher – 41700.75 mL blank matrix tubesAssay tube rackThermoFisher – 4896Empty latch rack for 0.75 mL matrix tubesAssay tube sealThermoFisher – 4463SepraSeal caps for assay tubes –recommend purchase in two colorsAssay plate(alternative to ThermoFisher’s4170, 4896, 4463)KBS-7001-13196-well V-bottom plate, 0.8 mL well volumeGreiner Bio-one – 786201Masterblock , 96-well V-bottom plate, 0.7 mL well volumeKBS-0750-100Adhesive plate barcodes (roll of 5000)Various vendorsAdhesive barcodesSterilizing basinVarious vendors 20 L volume, polypropylene sterilizing basinsfor oKtopure tip blocks5% Sodium hypochloriteVarious vendorsSodium hypochlorite for tip and tip block decontaminationHeat source for sample lysisAdhesive barcode labelsTable 2. Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test – equipment, software and other materials.6Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestComponentSourceDescriptionSodium hypochloriteconcentration test strips(both required)LaMotte – 3002Insta-Test Analytic High Range Chlorine Dioxide Test StripsDeardoff Fitzsimmons –77085Active High-Level Chlorine StripsPipettorsVarious vendorsSingle and multichannel adjustable pipettors(2 µL to 1,000 µL)Pipette tipsVarious vendorsFiltered, disposable pipette tipsPCR reagentpreparation tubesVarious vendors1.5 mL centrifuge tubes, 15 mL and 50 mL conical tubesTube racksVarious vendorsRacks for 1.5 mL, 15 mL and 50 mL tubesCold storageVarious vendorsLaboratory fridges and freezers (4 ºC, -20 ºC)Ice or cold blockVarious vendorsFlammable cabinetVarious vendorsCompressorVarious vendorsRO water supplyVarious vendorsDisposable,powder free glovesVarious vendorsCentrifugeVarious vendorsCentrifuge with rotors compatible withstandard and deep-well platesVortexVarious vendorsVortex – including plate adapterEthanolVarious vendors70-80% ethanol, molecular biology grade or equivalentIsopropanolVarious vendors70% isopropanol, molecular biology grade or equivalentMicrocentrifugeVarious vendorsTable 2. Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test – equipment, software and other materials. (continued)Control material(s) to be used with Biosearch Technologies SARS-CoV-2 Real-Time and End-PointRT-PCR TestComponentSource: ref #DescriptionUsePositive Control0505–0211AccuPlex SARS-CoV-2 RNaseP andviral template at 15,000 copies/mL ofN1/N2 Target and 30,000 copies/mL ofRP target, with polyA carrier RNAFull Process PositiveControl (PC) materialNegative ControlMajor laboratorysuppliersMolecular or PCR grade waterNegative Template Control(NTC)Table 3. Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test – control material.7Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestControls that are provided with the test include:a. A “no template” (negative) control is needed to ensure there are no unexpected amplification eventsthat may indicate a failure in the assay, a contamination event in the lab, or other mishandling ofsamples as part of the extraction, purification and amplification process. This control is included asan input into one well of each 96-well source plate that contains the raw clinical samples prior to lysisor purification and should be identified in the plate map file as “NTC.”b. The positive template control material is a SARS-CoV-2 Full Genome and human RNase P withspiked carrier RNA. The control material contains the whole genome of the 2019-Coronavirus strain(SARS-CoV-2) corresponding to GenBank sequence NC 045512.2., using SeraCare Life Sciencesproprietary AccuPlex Technology. The concentration of this control has been set to a viral load of15,000 2,000 cp/mL SARS-CoV-2; and 30,000 4,000 cp/mL RNase P verified through digitalPCR with an additional inclusion of carrier RNA at a concentration of 5 μg/mL. This concentrationrepresents a target concentration for N1, N2, and RP of between 2X and 3X the LOD of thismethod.This control is needed to provide assurance that the extraction and purification process wasexecuted as expected and generated an acceptable purified sample concentration as well as averification that the RT-PCR process is functioning as expected. This control is included as an inputinto one well of each 96-well source plate that contains the raw clinical samples prior to lysis orpurification and should be identified in the plate map file as “PC.”Human RNase P serves as an internal/extraction control and is detected using the 2019-nCoVN1/RnP and 2019-nCoV N2/RnP assay blends. Detection of this target ensures that sufficientpurification of the sample occurred, in addition to demonstrating the PCR process performed asexpected. This RNase P control can be used to flag samples that have a low concentration ofpurified nucleic acid for re-extraction and retesting as needed.Warnings and precautionsAs with any test procedure, good laboratory practice is essential to the proper performance of this assay.Due to the high sensitivity of this test, care should be taken to keep reagents and amplification mixturesfree of contamination. The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Testworkflow should be performed by qualified and trained staff to avoid the risk of erroneous results. Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. For in vitro diagnostic use only. For prescription use only.8Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test Laboratories should include a statement such as: ‘The test has been validated but FDA’s independentreview of this validation is pending’ in patient test reports to their healthcare providers. The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test has not been FDAcleared or approved; the test has been submitted to FDA under an Emergency Use Authorization(EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments(CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests. Laboratories within the United States and its territories are required to report all positive results to theappropriate public health authorities. Specimens should always be treated as if infectious and/or biohazardous in accordance with safelaboratory procedures. Refer to Interim Laboratory Biosafety Guidelines for Handling and ProcessingSpecimens Associated with SARS-CoV-2. Follow necessary precautions when handling specimens. Use personal protective equipment (PPE)consistent with current guidelines for the handling of potentially infectious samples. Refer to Biosafetyin Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC. Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents andhuman specimens are handled. Modifications to assay reagents, assay protocol, or instrumentation are in violation of the productEmergency Use Authorization. Do not use the kit after the indicated expiry date. Dispose of waste in compliance with local, state, and federal regulations. Safety Data Sheets (SDS) are available upon request. Positive results are indicative of the presence of SARS-CoV-2 RNA. Handle all samples and controls as if they are capable of transmitting infectious agents.Sample collection, handling and storageProper specimen collection, storage, and transport are critical to the performance of this test. Inadequatespecimen collection, improper specimen handling and/or transport may yield a false result. Sample handlingand storage should be consistent with CDC guidelines. The Biosearch Technologies SARS-CoV-2 RealTime and End-Point RT-PCR Test has been validated for use with upper respiratory samples and should behandled and stored according to the collection kit manufacturer’s instructions.9Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestSAFETY WARNINGHandle all samples and controls as if they are capable of transmitting infectious agents. Refer tothe CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from PersonsUnder Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19).Instructions for useMinimize the risk of contamination Use appropriate biosafety environmental containment for sample and reagent handling. Always use caution when transferring specimens from primary containers to secondary tube(s). Precautions must be taken to prevent cross contamination of samples. This entails only re-usingconsumables were appropriate and using aseptic pipetting techniques. Avoid freeze/thaw of the PCR reagents.oKtopure-IntelliQube SARS-CoV-2 detection workflowRNA purificationoKtopure preparation:1) Load new mandrel filters (KBS-09-MS027) into the oKtopure head. If new filters are already present,skip this step.IMPORTANT: Mandrel filters should be replaced prior to every run to prevent cross contaminationand ensure proper dispense volumes if previous filters encountered fluids.2) Load oKtopure tip blocks (KBS-09-127) onto the instrument.3) Load new oKtopure tips (KBS-0010-003) into the tip blocks. This may be performed using the manualtip picker tool (AX9921600 – optional item) or through the oKtopure software user interface.a. For the first run of the day, load tips into tip positions 1-12. For subsequent runs, only the buffer tipsshould be reused, new tips should be loaded into tip positions 5-12.IMPORTANT: Buffer only tips should be reused for no more than 3 runs.b. When performing tip transfer using the oKtopure software user interface:i.Prior to loading tips to positions 1-12 verify “Skip wash buffer tips” box is not checked Figure 1.ii.If only loading tips to positions 5-12, verify “Skip wash buffer tips” is checked Figure 1.10Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Rx Only For In Vitro Diagnostic Use.
Instructions for useBiosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestFigure 1.Extraction reagents preparation:Lysis Buffer MixturePrepare the required amount of Lysis Buffe
The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR test is to be used with the Biosearch Technologies oKtopure and IntelliQube instruments. The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test is a molecular in vitro diagnostic test that is based on the widely used nucleic acid amplification technology.
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