AMbedr Lerral, arate _werhieenm, fence fren wa we, gan weet vapor) BRET CHRO / ee /wHaS—19 / creel: 19 ore, 2027 ear weet Bt afeet fiber ray @ 8 True Nat-Real time quantative micro POR aitt & yer Prater TRIWNHS. tettge feet sree 4. GA 0280000387) M’s Molbio Diagnostics Pvt. Lid. Verna Goa wreqsi eee ay diva fren & fi g-Ae aes F wah eit Duplex Kits Sat fod ata / wd / Pat BT M/s Molbio at xi div a wa va Swe Hoag arafer & ct ae gw EET airs EA A AAP S07 76.01.2021 Hl Me TT weg fers) Rat @ rex oneh amafir demededy@gmail.com we ft oe wef] (dodo za) ETE | We THogo / oe /pilas—19 / 19, wefertn | feted PeifeRar @ ofa f wa aT ont) GIGS WR TSS BRT BT aE HE gorafaa, wae foto fevafterera | Freer, wae PaGCaT HRT | ree free, ovo Ae wes SRI, HH WA son ey) Yo \ 4 Wa We \ " fal ke aneEe ee Quotation No.N/Lko/150121 Date: 15.01.21 To, Director General Medical Education & Training, U.P. Lucknow-226001 Sub: Quotation of “IruenatCOViD-19 Duplex test kit” 0 / | Paveha se [JOAN 11. OF. 3 6 [= | item Description Cost per test [a | Truenat COVID-19 | Truenata single step test that detects theE ‘Rs 1000 Plus | | Duplex test gene and Orf 1a gene of the SARS CoV-2 virus GST@12% | | (with consisting of consumables such as | reagents,chips,VTM required to do this test) ‘TERMS & CONDITIONS '* DELIVERY PERIOD: 4 -6 weeks on confirmation of order from your side. + PAYMENT: Immediate after receiving part supply materials. VALIDITY OF OFFER: 30 Days from the date of quotation, © TAXES Extra GST @ 12% + DELIVERY TERMS : Delivery will be with in 30 days of confirm purchase order. ‘= SUPPLIES: Will be made through our authorized distributor to M/S Diokronic Medisys Put Lid + All dispute if any, will only be under the jurisdiction of the courts of Panaiji,Goa, '* We look forward to hear from your side & will feel privileged to address any of your concern(s), Deputy Zonal Manager Molbio Diagnostics Pvt Ltd Lucknow 7678869500,9415269500 Plato L-46, Phase . Vera industial Eta, Yer 33257 E mal: apmingimokberagrestcs comTOUR U RSENS Dated 15.01.21 To, Director General Medical Education & Training, U.P. Lucknow-226001 Subject: Declaration regarding Lowest Rate Reference: Supply of “Truenat COVID-19 Duplex test kit” We, Molbio 1gnostics Pvt Ltd, Goa, do hereby declare and confirm the following: That the rate quoted to DGME is the lowest rate quoted to any Government/ non Government Organization and we shall not quote below this rate to any Government) non: Government Organization. If found in future after issuance of Purchase Order that we have quoted any lower rate to any Government Organization / non-Government Organization , the double of the difference ammount will be deducted from our payment. 1, That the statements made above are true and correct to the best of our knowledge. 2. That the statements if found incorrect, we understand that the department is free to take action agsinst us. Thanking You. Molbio Diagnostics Private Limited fags Offs & Woks Plt No- 46, Phase ID, ere nds! Ese, Vora Gos 409 722 DIA “el. 197- £22 2783207 € malt adifroboiagnoss cum Ena see@nbio agnostics etn Website nna macagnssis com CON: USSI2SGRA000PTONIZEDE. STW SOAACCNEZTIEIZOINDIA NON JUDICIAL Government of Uttar Pradesh e-Stamp Cerificate No In-uP237 182863805557 Cerificate Issued Date 2 14-Jan-2021 03:12 PM Account Reference 1 NEWIMPACC (SV) up 14243404! LUCKNOW SADARY UP-LKN Unique Dos. Reference SUBIN-UPUP 142434044007 12718336207 Purchased py MOLBIO Diagnostics Pvt Ltc Description of Document Article 4 Atidavit Property Description For Govt Affidavit Consideration Price (Rs.) First Party MOLBIO Diagnostics Put Lie Second Party Not Applicable ‘Stamp Duty Paid By MOLBIO Diagnostics Pvt Ltd ‘Stamp Duty Amount(Rs.) 100 (One Hundred only) Please write or type below this ne... PROPRIETARY ARTICLE CERTIFICATE ia HEB TER sy that Motbio Diagnostics (P) Limited, (Factory) Plot No 46,-Bhase UD, Verna Industrial Estate, Gon - 403 722, is the a and marketer of the Patented “Truclab!™ Real ‘Time TPCR system” comprising of the ‘Truclab!™ workstation and along with Truenat™ micraPCR/RTPCRBoth the Truelab™ Real Time microPCR Analyzer and the Truenat™ microPCR/RTPCR chips are protected by International Patents & Patent Pending and corresponding claim of any foreign counterpari(s) thereof, and hence the said products are proprietary in nature. For Molbio Diagnostics Pvt. Ltd., SIGNATURE ATTESTED Feurt « india 3 liGar2u00 ‘js LCEEL< SAIS ATMS UTA, CTS SS TRS INDIAN COUNCIL © BRUT WATTS, ATT ACHTE MEDICAL RESEARC! Indian Council of Medical Research Department of Health Research, Ministry of Health and Family Welfare, Government of India Date: 24/09/2020 Revised Guidelines for TrueNat testing for COVID-19 ‘The TrueNat system is now a comprehensive assay for screening and confirmation of COVID- 19 cases. + Sample is collected in viral lysis buffer and hence biosafety and biosecurity requirements for use of TrueNat are minimal. «© Types of assays: ‘There are three different types of TrueNat assays available now: 1. Assay 1’: TrueNat Beta CoV E gene Screening assay. 2, Assay 2: TrueNat SARS CoV2 RdRp gene confirmatory assay. ‘Assay 1 needs to be followed by Assay 2 for confirmation of the results. 3. Assay 3: TrueNat Covid-19 Multiplex assay. Detailed guidance on use of the assays is as follows: 1. Two step singleplex assay A) Step 1: This is E gene screening assay. All samples of suspect COVID-19 should be first tested by this assay. All negatives are to be considered as true negatives. All positive samples should be subjected to confirmation by step 2 assay. B) Step 2: RdRp gene confirmatory assay. All samples that test positive by this assay must be considered as true positives. 2. Multiplex assay- TrueNat system is also now a multiplexed point of care test that includes a single assay comprising of both the screening (E gene) and confirmatory (Orfla) targets in a single test. All samples of suspected COVID-19 cases can also be tested by this assay. All negatives are to be considered as true negatives. All samples that test positive by this assay must be considered as true positives. «No further RT-PCR based confirmation is required for samples that are confirmed as true positives by the TrueNat assays. * All positive and negative results must be reported to ICMR portal on real time basis. 2°) w/ 11 PF Re(AN ENTERPRISE OF GOVT. OF AP.) 2" Floor, Plot No 8, Survey No 49, IT Park, Mangalagiri, Guntur -522503, P.O.No:284/437/APMSIDC/EQU/2020-21 Dt:27.09.2020 To Mis. Molbio Diagnostics Pvt. Ltd. Plot No. L-46, Phase |i D, Verna- Industrial Estate, Verna — Goa 403 722. Sir, "Sub: APMSIDC — Equipment Wing ~ Procurement and supply of Truenet Multiplex Testing Kits including both screening (E gene) & Confirmatory kits to various Govt. Hospitals in Andhra Pradesh for COVID-19 — Purchase Order Issued — Regarding, Ref: 1, Lr.No.Dr YSRAHCT/COVID-19/Truenat — kits/2020, at: 15.09.2020 of CEO, Dr YSRAHCT & State Nodal Officer for labs, COVID ~ 19. 2. Quotation received from i/s. Molbio Diagnostics Pvt. Lid Dt21.09.2020 Adverling to the references cited above, you are requested to supply of Truenat Covid-19 (Dupix) Test Kit to various Govt. Hospitals in Andhra Pradesh with a contract value of Rs.11,20,00,000/-Including all taxes. The supplier has to abide by the terms and conditions mentioned in Annexure |. You are requested to supply and install the items and submit 1) Original bills with stock entry, 2)Delivery challans, 3)Instaltation(if applicable)’ Performance report In original duly certified by the concemed head of the instituterhospital along with recommendations for payment of the bills failing which no payment will be processed. After the complete execution of PO quantity, the FSD will be released after 3months duration from the date of installation based on the performance report obtained from the Head of the institution or concemed authorities. It is also informed that, if any instance comes to the notice of the corporation that the above equipment are supplied at a lower price than price quoted now then @shall also entail blacklisting of the firm for a minimum period of three years for particular product. Yours faithfully a .-te for M4gaging Bi ined Copy to:- AAR 4. The Superintendent of Various Government Hospitals as per Annexure with a request to inform the concemed Authorities to take over the material and Issue material received certificate to the suppliers and also submit the Original invoices with endorsement of the stock entries in the prescribed proforma enclosed herewith to the corporation for payment of the bill The CEO, Dr YSR Aarogyesri Health Care Trust, Guntur for information 3. The Finance Officer, Head office, APMSIDC ~ for information and necessary action. 4, The Bills Section, Equipment, Heed office, APMSIDC — for information and necessary action.et te ee ENV VEU lem Description | Unit} Qty [Unit Rate] GST@ Amount | Rs. 12% (Rs) T [TRUENAT COVID-19 | Kits | 100000 | 1000 120] 1,120] 17,20,00,000 (DUPLEX) | | {SCREENING & | | ICONFIRAMTION) | Total Amount: 17,20,00,000 | rms & Conditions: _| 4) [Contract Value in + [Rupees Eleven Crores Twenty LakhsOnly Words: 2) [Total items [One item Only 3) [Unit Rate Inclusive of all Taxes 2) [installation “|Not applicable. 5) [Uptime Clause + [Minimum uptime 85% of 385 working days. 6) |Liquidated Damages |: |LD's willbe levied for the delayed goods at 0.5% per lweek, subject to maximum of 10% of contract value. 7) [Payment tems : |). 90% of the contract value of the supply part, after ldeduction of statutory taxes, wil be paid to the |supplier on submission of copy of invoice with original Delivery Challan as proof of supply to destinations jand provisional stock entry duly certified by the il). The balance 10% of contract value of the supply part to be pald after 3 months from the date of installation (from the date of supply when installation is not applicable) on submission of performance satisfactory report in the proforma given under |Annexure-XVI, obtained from the Head of the institute or concerned authorities. 8) |Siockentry, —*(| _-: [Tobe submitted in the prescribed format enclosed Installation & | herewith Performance Certificate | 9) [Delivery Period? |: |Supply & Installation of the tems at the final Terms. | destination within 15 days from the date of receipt of | this purchase orderChip-based Real Time Duplex PCR Test for COVID-19 ‘ruonat™ COVID-t9 (REF 60143000516014300701601430050) isa chiptased Real” duplex Reverse Transcption Polymerase Chain Reacion (RTPCR) toe fer the sori quanitatvedctocton of SARS CaV-2 RNAInhumanoropharyngoal and nasopharyngeal swcb specimen and ads hn detection and confirmation of SARS. (Gov-2infecion and diagnosis of COVIO-18, The es! eetecs Ine Eand Oregons othe vin, Truenat™ COID-18 runs on Truclab” Res! Time QuanitatvomicroPCR Analyzes. SARS Col 2s the causative agent for coone vu disease 2018 oF COVID9 in Humans. SARS CoV 2is a Beta Corone Veus, ane ofthe four goera of Corona vieuses.Coroaviuses are enveloped ren-segmented poste sense RNAVises longing te the fanty corraviae and the order Neowraes end brosdy nnsna by 'an0ro 'ix(6] uLothis clear sohonis hen rinetad cuLusing te sane pinetic and ig anduspensed inks the reackon ello he Truenat"™ COVID-19 chip and the les! is inserted in the Truelab? Reel Time Quanttaive mio FOR Analyzer where the RNA is ist convetod iio samplamantary DNA (DNA) bythe RT erayme and funher tormal eyeing takes place. & positve angifeaizn causes the dual labeled Auorescet probe in te “raenat" COVID-13chip-based Real Tine PCR est a release the fuerophores erga ae ea Rae ea ee eT ee eee tue acd inthe sare Inthe ase of negatve saris, amplification doe ‘cturand a hoizontl ampticaon cure is played on he screen dug the tun At the en ofthe lst un, Ef Ota yee DETECTED’ "NOT DETECT tess dispayed anain positive cases, seni queritane resis io day thescrean Baeedon hecetocton elena peste corral (PC), thal {helesun sas dsployed. Th ik ul recess conto tal undergo a processes ‘he specie" undergoes «from exvaoton 1 amplicon tet Yala he est un fo sample feu. Rosence fo shat PO Cbeye: prose enge incase of negalve samples ivaldeles esr. Whi il Epi» most postive cases s,s specmen hig igh ages, IPC nay natenply however etn si eared ve Tere cr péstsd using tne Tula’ nico POR pater or tarsere io hea camper Bry remote compu vi il network r SO'GPRS retwak, Uplo 20000 res “ruclab Une DiDuofutio can be sted on tre snare rea rornce TARGET SELECTION ‘The target sequence fortis kts ard Ore gone anc human RNase P Detect the human Riso Pgene serves as a ullprocessintaral postive contol (PC) ‘oper swab lection nudeiceed extraction and PCR AInhidvaly sealed pouches, eaencatininga 1. Teuenal COWD-18mici PER. 2 Mirae win oeze Sieg RTPOR agers 4. DNase & RNase fee pipet, 4, Destocat pve &. Package set Geen | por4s0005] 67430020] 601430050] yt os | om | st | BOF THE Truce AUTO Univers! SarplePo test A Lysis Butler (contin ysis cum vans medium) B Disposable ranserspee raat, TRE | esas Sonosnea enanenbsd wil | wo | or CONTENTS €F THE Trusprep. AUTO Transport Mes or Swah Speciay ‘A Transpetbedium or Sab specimen ues (contains tarspor medium) ‘supUSTS05| 205720] ena06eT SH) wy ar zor | sor STORAGE AND STABILIT ‘Truenat™ COVID-18 stable foc two 2] years rom he dale of manufacture soe between 2-00, is also sabe fo upto one 1) marth al emgealures upto 45" ‘Ais exposure tog or elevated temperatures (stove recommended tves).C rotheeze, “ruoprep* AUTO Uriversl Semple PreTrealient Pack arg Trueprep" AUT “ranepor Madiam for Swab Specimen Packs lobe fr wo (2) yeas fom the da of merufactre fsiorad belisen 2-40°C, iis also stable fr one (1) month temporalvesupte4SC. TTERIALS REQUIRED BUT NOT PROVIDED Wit THE: Truclab RealTime mic PCR Workstaton (REF E720‘0CHE30T0001! 649010011652010001) coristngot 1. Trueprep* AUTOIAUTO v2 Sample Prep Device(REF8030410011608042001 2. Truslab’ Uno DxTruelab® DuofTruelab' Quatro RealTime nico PCR ‘analyzer (REFEO02 100160302200 '1602C23001). 4. Trualab’ mio POR Printr (REF 693080001). 4, Trueprep” SPA fixed volume precision mcropipatie- 8 pl (REF 604070006) 5, TruolabY Mizcute Stand REF 602670001), ‘Aso required addWonaly are. Truopras" AUTO Universal Sample Pre-Treats Pack [REFBOZ0EABOS/REFEO2C5AB20/REFEOZO5A860) Trueprop* AUT “Transp Mein 1 Sab Specimen Pack (REFEOQOBTSOGIRE 602067 $201 REFEN2OGTSSD), Trueprep” AUTO Linversal Caidve Basod Sarpi2 Prep F (REF5U203ARUSIREFSC2DSARZSREFSO203AR50) or Truoprep’ AUTO x Unvetal Garbage Based Sample Prep kl REFEC207AROS4 R25) -REFEO207ARSO),Trusnat™ Universal Gontel (REF 601 0@g8) Powder fe eposthie lowes, waste spesalecriner vissapecieven trio tee Teansport Median far Swek Specimen Fube-paviieci eric i wee byrepeately bing the swao in he bute soliton. Gal break the hance ofthe nyfon swab atthe Break cor, leaving the swab contarig the specimen Inthe “anspor Medum for Swab Specmen Tube. Tig cose the cap of he Transport Medium for Suse Specimen Tube (Refor‘o ho packago sero! Trueprep® AUTO ‘rans, Medium for Swab Specimen Pack fr fre” ceils)» Dispose of the remaining part of he swab afer se, 2s per the section on “Dispose! arc Destruction Secton 1), ‘Sample Storage and Transporato ‘Transport Mecium fo: Swat Specie decontaminalas the specimen and makes it ready for storage vanspantaton/extanten. The specimen mths mis stable forup tothree (days a 4°C and one{t) week at 30°C, Nucleicacidextraction: “Transfer $00 pom the Transport Mesum for Swab Specimen Tube nto the Lysis Ue Tubefor oropharyngeal or nasopharyngeal swabs fo: futher proedure(Reer tothe package inset of Trueprep AUTO Uriversal Sanple Precteaimert pack for further deals) wih the Trueprep” AUTOIAUTO v2 Universal Cartridge Based ‘Semple Prop Device anc Truaprap* AUTOIAUTO v2 Uriversel Cartidae Based ‘Semplo Prop Kt (Refer to he Usor Manualof Truoprep* AUTOIAUTO v2 Universal Cartidge Based Sample Prep device and the package insert of Trueprep* AUTO/AUTO v2 Universal Catidge Based Sample Prep Kforce), Dispese off the Trenspont Medi for Sweb Specimen Tube wih cp, ysis but lube wi) cop and Wwansl’ pipette afer use, as per the secon on “Dispose and Destruction” (Gestion). ‘SAFETY PRECAUTIONS 4. Forinvirodhognasieuse only. 2. Bring llreagents and specimen toroomtemperture (20 20°C) beforeuse. 8. Donotuse beyond expiry dal. 4. Careluiyreadtne Userblanuls andpackage insets ofaline components of lhe Truelab* Real Time micro POR System befor use. ‘Allmateias thurman orgin shouldberandledas though potentalyinfectous, Donotpipete anyraterialby mouth, Do not eat, dink, smoke, apply cosmetics or handle contact lenses inthe eee wheteiesingis done. 8. Use polectve doting and weer disposable cloves when handing samples and while peroringsempleexracton. 2. PROCEDURAL PRECAUTIONS 4. Check al packages before using the kt. Damage tothe packaging does net prevent theconeis ofthe from being used. However, the outer packaarais ‘Samogod he veermysteenfem that indudual componente of te at ave act ‘before using hem 2. Dano geriomn te tos inthe presence of reactive vapours (eg fom Sodium hypattlore, acids, alas aldehyces) or dust, 3. Wile revevng the Truenat™ COVID-19 micro PCR chip, mcrotube andthe DNase & RNase fee ppela ip om the pouch, ensure thal nthe bare hands rot gloves thal have bean usad for previous ess runereuses. mee 5, PROCEDURAL LIKTTATIONS 1. Optimalperfermancecfthistetequies appropriate spacimencllection, handling sragearc transpottothe esse 2 Though war er, mutatons wahin the Tghly conserved regions ofthe target genome where he Trvenat™ assay oimers andlor probe bind may resutin the “ndor-quantiaton of or 8 flue fo detec! the presence of te concemed pathogen 3. The instuments ard essay procedures are desined to miniize the isk of contamination by PCR argicationpreducs, However, ti eseril to fotow 00d laboratory racices and ensure careful adherence o the procedures peated inthis package set for avoiding nuléic acid eontzmination ton ‘revious ampications, pois cons r specimens, 4, Aspocinen for which ho Truonat™ assay reports "Not Detected cannot be ‘oncludd lobe negative forthe concerned pathogen. As with any diagnose tes, resus rom the Truenat™ assay shouldbe intergreted in he cone ermal and laboratory ndings. 1 CLEANING ANDDECOKTAMNATION 1. Spils at polenta intcious mater shouldbe cleaned vp immediately with slsorbent paper issue and the cortaminateé ares should be decontainates ‘wth csinfctants such as 0.5% fresly prepared Sodium hypachire 10 tines ‘itl of 5% Sodium hypochors(houscholbeach)} before continuing work. 2, Secium hypeehonteehau not 9 used on 2n acid-tontanng spl uriess the spihareaiswipeddy frst. Materials used to clean spils, inccing loves bai ae 1. ShichontteTueab watz 2 SsleeiUsererdenierpassvor. 4 ForTruelak* Uno Dx, clot txt pola f roles Screen onthe Analyze see. Fo Tula" Duo/Quao, sec! By eV) orDuoard 24) or Quattro ete Status Sereno the Profies Steen Selec he est profiel“ Ote ger’ bean tom Profles Seen nthe lye screen. 4. Enter patetetaiss promod inte Tusa fralyesreen Press Stat Reacton 4 ForTruslat Uno Ds, Presse eectbuton io open chip may For Tat Duottuats, he op Fay apes auometzely en tpping he ‘Sge Rasch uron 7. Openapouchof Tuenat™ COVID-1BardretievethomiceoPCReNp. mic, andDNce BRNaceries pipet tp {Lebel he chip end te tne wine pallet |D sing @ maker on athe spc provided ene backs olthecip ee te space onthe merbslabel {8 Paves Truonst™ COVID-8 chipon he pay wine taLenng the wt teacton wel. The reaction wel shul be facing upan way tom te Anat Gerdypresstne chiptoensretrathas seated the cip wy prone. 10, Pe he ricrtube cotiing feze die RT PCR reagan enc ster provlee alone wih fw Trueteb Rea Tee mire PCR wrktton aft ensuring that white pelt of ried PCR resgents remains a the Battom the mierotube, Remove te nierotbo cap anc dispose ofa pr he oct con" Disposal and Destusien’ (Secon 18), Us the er bari p provided thepouch pnt outs 6 lft pid RNA tome Ete Colesed Tu inigthomicotsbe. Alo it standlor 300 seconds a geile sur. ‘sig the sae iter bar 4, pipete oss) uo! th lea souton and sponse te cee oft wl reacion wollte Truenat™ COVID-1 cri, Taka carenatioscaidht ital wolsrtace and oto spl ute onthe cus ofthe wel. Digosec ‘he miotp as perthe seatono Disposal and Destucion’ ection 1 11, For Tuclab* Uno Dx, siete chip ay earring te Tuenat™ COMA chipset Rea! Time POR ist oes wih the sample in the Truaal ‘Analyzer. PressDone othe “ease oad Sample" Alert message Fe Tusa DDuoiduato,slect “YES” athe Pease tod Sample prompt. Cp tay w close automata and hereactonval slat 12, Resdheresuttomthescren 18. Alter the reacton complied, fo Tel Uno Dx, push te Eject ton ‘echo ip oy. For Tueab* DuclQuato te he"Oae ioe Ty bt toojecthachipey 14. Tote out Truenat™ GOVID- chip based Tine POR tstt ent ‘estan dapat of as perth section on ‘Disposal ane Dese uno Seale 48) 15. Tum on True" mioro POR printer andselet pint he steanforproirge hardcepyo!the resus Tt rasuls are aorta stored and can t retivedey mela. (Retertothe TlsbAnayzermenval). 16, Swichsthe Tusa Anajze- Ora gene tobe enor RESULTS & INTERPRETATION: Tee ampifclion curves ae daplayed onthe Tuelab* Real Time micro PC ‘Analyzer sreento indices the progress othe eet. Boh te largot and th intern postive contel (PC)* cures wil take a sleep, exponential pah when th fuorescence crosses tho trecold vale incase of posto saps, The ie take (Ci ofthe specimen wil depend on the numberof virus copies in the serge, Th ‘urvewil emainhorzonatroughout the test duration and he Cure wilzies fexoonenta palin case cf nagatvs samples, In case the IPC curve remit hoiznta ina negative sample, fe ests consiceredas Invalid Alte endof hte run, the resus screen wil display DETECTED" for Posive result of “HO DETECTED” for Nogafve rest. The resul sreen cud aso Gsplay th valor ae “HIGH, ‘MEDIUM' "LOW? 0: VERY LOW” for postive specimen. The rest screen aso displays the val ofthe fst run as "VALID" or “NVALID’. nv samples havea be epeated wih eshspocimen fom thasarplerezarationslag "Wie IPC wil co-emiyin mos pos ve cases alo, in ome specimen ving ightargetload the PC may not ama howoverthetet-un itll consiseres TASES Es = ? cova AES‘Whenevera new stypmen of lestkilsis received. ¢ When opening anew test kitlct, © tthe temperature ofthe storage ares fal outside of 2-30" C. © By each new vser rior to perormingtesing on cirial specimen, Submerge the used conten! such as Trusnat"™ COVID-19_ chip, micotuba, mmicttube cap, ipa ps et. in freshly prepared 0.5% sodium typochare Solon for $0 minutes beore disposal as per the slandarc medial waste sposal uidetnes 2, Disinfect the sobtons andlor sold waste contzning bciogiel samples beore «scaring them acon localreguators, 3. Samples and reagents of human and animal origin, as wel as contaminates matenals disposables. neuratzed ace anc olver waste mctrale must be ‘discarded aotardng talcel equations ater decontaminatonbyinimersenina ‘rely prepared 0.5% ot sodium hypoctlort for 30 mires (t volume of 5% sodium typochorte for 10 velumes of water) 4, Donotaulolave materiel orsolsionscorainingsedumbypachot. 5. Chemicals should te handled naccordenoe wih Goos Laboratory Pracce end ispasedof eaoordng ot eal egsatons SPECIFIC PER Performance parameters ‘Analytical Senskivty: Evaluation oanalyial sensi of Truenat™ COVID-18 asta. n comparison to ‘Tagan SARS COV-2 gRT-PCR VRDL assay was pertormed. Sampo wih low Ct valu (1084048) was used fori tue. An alquctof VTE cf sample 54049 wes ‘extracted using Trueprep’ AUTO Sample Prep Device (As per manufacturer protocol). RNA was diutd 10 fold end six ditutens were made fom Truepren* ‘AUTO elt. These don series were run cn Truenat™ COVID-t9chips es wel ‘as Taq Man SARS CoV.2 gRTPCR systems in parallel, Observed Ot values ae ‘giveninbelow abe Tsai COvD-10 “agnor SARS Cor VON Semple © [ones | eGene | rwAseh] onFte | Ecore | RvAser sions 01 | wer | tox7 | argo | cam | mere | case sims or | zoe | rots | ars sie 01 | 960 | 1200 | 2730 sume co | mm | 27 | sie | sem | mar | sear seme 02 | zze | 200 | ai. [ woe oe | 20 | 233 | an00 | seme 03 | 220 | 290 | sass | are | sie | 6 ious 03 | 2520 | ass | a3 swome 03 | 2.00 | 2580 | 3380 ‘019 04 au | no | no | seas | 0 089 04 7320 | eee es} Be | o siois os | s20 | st0 ND cs sunss os | seze | a9 { ses os | sooo | acts e008 De ND | NO [| 0 Sata 06 | no | No xo | 0 | say detecied upto dluion 10°08) am unuted ‘sample, wih vali Cvae eae 0 To 2. Linearity & POR Etficiency: Using tho ciuon series from Trueprop" AUTO elites nin on Truenat"™ COVID-18, loglnear cure was pote te checkthe nertycf Cl valu on Truenat™ COUID- 19lest 4 Analytical Sonsilvity test with saps of low viral load: Eceluation of enelyical sensivity of Truanat™ COVID-48 muBloxed PoC te comparison to TalMan SARS-CoV.2 RT-PCR VRDL assay was perfomed Sermpes wih iow wal cad (I val copy number) for rt E gene Wes use this study. An aiquot ef vis transport medium (TI) contig sample ‘extrac using Trueprep” AUTO and 12 renlcates ofeach sample was 1 Truenat™ COVID-18 and compared against TacMen SARS Co\o2 qRT-PCR V assay ‘Conclusion: All replicates of ow viral load sariles were detected by Ten COVID-19,Ottaassay. 5. Precision To evalule reproducilty and repetaiity of the assay, ten clinica el representing High, Medium and Low Ci values ‘Sample DeS4053(Ct20, 547 16(C1:26.8),$4724\C:14.71),54745(C1.29.43),84803(C1 14.11), 84 (0422.85) 54976(Ct24.06),54928(Ct20.43},69056(CL:14 60) SS119{C124 ‘were run devices used i his evaluation. Fokowng table depicts the Proc fea iver Ege ards ae ven wih chee strded des ard Cv, aay Hee reer eee Pie Conclusion: The test was found to bo reproducible wih percent coafeen ‘vatation less than 8 wich s wal below the accepted 10%, across ample « btneen dviens 6.clincal Sensitivity: Clinical senstvly wes toted by rumingt0 confemed posivas samples of SAF (COV.2; representinghigh|12|,mesium{{3]ane low C15] value samples frost and comparigon wih bots te systems using thee lle of Truenat™ COVID-9, poste cemples were detected byallthree tots of Truenat™ COVID-19 assay. 7, Specfcty and eross reactivity: ‘Speciciy ofthe tes! was evauoied using & panel of cna samples, inc COVID-18 negatives end other respralory diseese postive ones. The pal ‘neue HIN (26sarples 8 psive and30 Nagata), Sevae Beste Resp ress (SARI) (80 samples), a also band samples (3 ram SARS CoV? post cases 2nd 3am SARS Cov? regatva cases} and confrmed COVD-1 regaty (Goswab samples) wereused E geneand Orta was rot elected n any f above epocimans, indicating spect anna cross reslvytnothercommonrespilorpaogens. 8, Clnicatevaluation: Clrical evaluation of Trusnat™ COVID-19 wes pefomed a the Sie VRDL lab ‘Bangelore Medical College. Totaly, 4S confrmed SARS CoV'2 postive end coninmed RT-PCR negate samples wer tested, ‘SARS CoV 2 realtime POR (n= 118) “Nogatve [We [oe — 7 | ‘Al posive end nagaives were crrely detected on Tuenat™ COVID-19 assi fain 100% erty, speci rd 0% once Concrete re nfo WO) Posiive Tuenet™ covin-t8‘severe peute respiratory syndrome, N Eng! J Med 2003; 348, 1953-66. WHO. Middle Eas respiratory syndrome coronavius (MERS-CoV), Noverber, 2018 npn wn invemergenciesmers-covfer (accessed Jen 9, 202). S.A Movelotnavius ~ China en 12,2020. pylon 2- january. 2020-noveb-coronavius-chnaenl (accessed Jan 19,2020), ‘WHO, Novel cornavius ~ Thailand f-China). Jan 14,2020. -htprmewho indesidon/jenuary-2020-novel-coronaiusthaanden! (aocessed Jn 19, 2020. fAy @: molbio tu Molbio Diagnostics Private Limited Registered Office & Manufeturing Unit Piot No, Lo#6, Phase ID, Verna Industil Estate, Verna, Goa - 408 722, INDIA ww malbiogizgnastcs.com 2840 Geol, 8 in