COMPENDIUM OF INSTRUCTIONS FOR COVID-19 TESTING LABORATORY Medical Education and Drugs Department Government of Maharashtra FIRST EDITION 21 April 2020 Medical Education and Drugs Department COMPENDIUM OF INSTRUCTIONS FOR COVID-19 TESTING LABORATORY FIRST EDITION Editor -in -chief Dr. Sanjay Mukherjee, IAS Secretary Medical Education and Drugs Department Government of Maharashtra Editors Dr. Rajesh Karyakarte, Dr. Sachin Mulkutkar, Professor Professor B.J. Government Medical College, Grant Government Medical College, Pune Mumbai Co-Editors Dr. Rakesh Waghmare, Dr. Mandar Sadawarte, Associate Professor Assistant Professor Grant Government Medical College, Grant Government Medical College, Mumbai Mumbai FOREWORD As you are aware, COVID – 19 is widely spreading across the country, rising beyond 15000 positive cases in the 12th week. In order to manage and contain the spread of COVID – 19 any further, both Centre and State Government and Associated Departments have come out with Guidelines and Instructions for COVID-19 Testing to be adopted across the country and in each state. This Compendium is a compilation of instructions & guidelines for operating a Covid-19 Testing Laboratory issued by Ministry of Health & Family Welfare, Indian Council of Medical Research, Government of India and instructions issued by Medical Education and Drugs Department, Government of Maharashtra. We hope that this compilation helps Laboratory In-charges, Administrators and all people involved in Testing of COVID – 19 cases. The first edition is updated with the information issued till 21st April, 2020. The Editorial Board shall be updating this on a regular basis. We thank you all. INDEX S. N. SECTION TITLE WEBLINK PAGE A Testing 1. DMER SOP for Operating 1-5 - Strategy & Covid 19 Testing Laboratory Guidelines 2. ICMR Specimen https://www.mohfw.gov.in/pdf/5Samp 6-7 Collection, Packaging, le%20collection_packaging%20%202 Transport Guidelines for 2019 019-nCoV.pdf novel Corona virus 3. ICMR-DHR Advisory on https://icmr.nic.in/sites/default/files/up 8 sample collection sites load_documents/Advisory_on_sample _collection_strategies.pdf 4. ICMR Specimen Referral https://icmr.nic.in/sites/default/files/up 9-10 Form load_documents/SRF_v3.pdf 5. ICMR Proforma Private https://icmr.nic.in/sites/default/files/w 11 Laboratories hats_new/Performa_Private_Laborator ies.pdf 6. ICMR Strategy of https://icmr.nic.in/sites/default/files/up 12-14 COVID19 testing in India load_documents/Strategy_COVID19_ Dated 17-03-2020 testing_India.pdf 7. ICMR Revised Strategy of https://www.mohfw.gov.in/pdf/ICMRr 15 COVID19 testing in India evisedtestingstrategyforCOVID.pdf (Version 3, dated 20.03.2020) 8. ICMR Strategy for https://icmr.nic.in/sites/default/files/up 16 COVID19 testing in India load_documents/Strategey_for_COVI (Version 4, dated 09.04.2020) D19_Test_v4_09042020.pdf 9. Applications invited from https://icmr.nic.in/sites/default/files/up 17-19 Government & Private load_documents/Invitation_from_Gov Medical Colleges for setting t_Pvt_Medical_College_COVID19_te up COVID-19 testing facility sting_facility.pdf 10. ICMR Advisory for https://icmr.nic.in/sites/default/files/up 20-21 initiation of additional load_documents/Criteria_for_initiatio COVID 19 testing n_additional_COVID19_testing_labor laboratories atories.pdf 11. Advisory for ICMR https://icmr.nic.in/sites/default/files/up 22 approved private labs that are load_documents/Additional_Private_l doing COVID 19 testing by ab_advisory.pdf Real time RT-PCR 03.04.2020 12. MOHFW-ICMR https://www.mohfw.gov.in/pdf/Notific 23-26 guidelines for COVID19 ationofICMguidelinesforCOVID19test testing in private laboratories inginprivatelaboratoriesiIndia.pdf in India 13. ICMR SOP for Detection https://icmr.nic.in/sites/default/files/up 27-33 of 2019 novel coronavirus in load_documents/1_SOP_for_First_Lin suspected human cases by e_Screening_Assay_for_2019_nCoV. rRT-PCR First Line pdf Screening assay 14. ICMR SOP for Detection https://icmr.nic.in/sites/default/files/up 34-39 of 2019 novel coronavirus in load_documents/2_SOP_for_Confirm suspected human cases by atory_Assay_for_2019_nCoV.pdf rRT-PCR confirmation assay B Testing 1. ICMR Govt Labs for https://icmr.nic.in/sites/default/files/up 40-45 Laboratories Covid-19 Testing on load_documents/Govt_Labs_2004202 20.04.2020 0.pdf 2. ICMR Private Labs for https://icmr.nic.in/sites/default/files/up 46-49 Covid-19 Testing on load_documents/Private_Labs_20042 20.04.2020 020.pdf 3. ICMR Status of New Labs https://icmr.nic.in/sites/default/files/up 50-54 20.04.2020 & Protocol for load_documents/Status_New_Labs_2 approving a COVID-19 0042020.pdf testing facility 4. ICMR Advisory for DBT https://icmr.nic.in/sites/default/files/up 55 CSIR DST DAE ICAR load_documents/DBT_DST_CSIR_D DRDO Labs AE_ICAR_DRDO_Advisory.pdf C ICMR Covid- 1. ICMR Validation Centres https://icmr.nic.in/sites/default/files/up 56 19 Testing Kits for qRT-PCR Diagnostics for load_documents/List_of_Kit_validatio Information COVID-19 12-04-2020 n_Centre_v_12042020.pdf 2. ICMR Performance https://icmr.nic.in/sites/default/files/up 57 evaluation of commercial kits load_documents/Real_time_PCR_test for detection of SARS-CoV-2 s_20042020.pdf RNA by Real Time PCR 20.04.2020 3. ICMR Performance https://icmr.nic.in/sites/default/files/up 58 evaluation of commercial kits load_documents/Real_time_PCR_test for detection of SARS-CoV-2 s_17042020_v.pdf RNA by Real Time PCR 17.04.2020 4. Guidelines for use of https://stopcorona.tn.gov.in/wp- 59 Commercial PCR Kits for content/uploads/2020/03/Guidelines- nasal or throat swab-based for-use-of-commercial-kits-for-nasal- diagnosis of Covid-19 throat-swab-based-diagnosis-of- 10.4.2020 COVID-19-in-India-10.04.2020-1- Page-English-435-KB.pdf 5. ICMR Testing Guidance on https://icmr.nic.in/sites/default/files/up 60 use of Commercial Kits for load_documents/Validation_of_Com nasal and throat swabs mercial_Kits_02042020.pdf COVID19 2 April 2020 6. ICMR Guidance Document https://icmr.nic.in/sites/default/files/up 61 on use of TrueNat Beta CoV load_documents/Guidance_TrueNat_1 4042020.pdf 7. ICMR Additional guidance https://icmr.nic.in/sites/default/files/up 62 on TrueNat based COVID19 load_documents/Additional_guidance testing _on_TrueNat_based_COVID19_testin g.pdf 8. SOP for Multiplex Real- https://icmr.nic.in/sites/default/files/up 63-69 Time PCR for detection of load_documents/SARS_CoV2_using_ SARS-CoV-2 using TaqPath TaqPath_COVID19_ComboKit.pdf COVID-19 Combo Kit (Applied Biosystems) 9. ICMR BGI SARS https://icmr.nic.in/sites/default/files/up 70 Coronavirus – 2 Real Time load_documents/3_BGI_Real_time_P RT-PCR CR_SARS_CoV_2.pdf 10. ICMR Advisory on https://icmr.nic.in/sites/default/files/up 71 feasibility of using pooled load_documents/Advisory_on_feasibil samples for molecular testing ity_of_sample_pooling.pdf of Covid-19 11. Advisory for use of https://icmr.nic.in/sites/default/files/up 72 Cartridge Based Nucleic Acid load_documents/Advisory_on_Cephei Amplification Test using d_Xpert_Xpress_SARS_CoV2_testin Cepheid Xpert Xpress SARS- g.pdf CoV2 D Rapid 1. ICMR Testing - Guidance https://www.bilcare.com/icmr.nic.in_s 73 Antibody Test on Rapid Antibody Kits ites_default_files_upload_documents_ COVID19 28 March 2020 Guidance_on_RapidKits_COVID19_2 8032020_V1.pdf 2. ICMR Advisory Rapid https://icmr.nic.in/sites/default/files/up 74-75 Antibody Testing 04.04.2020 load_documents/Advisory_Antibody_ Testing_04042020.pdf 3. ICMR Guidance on Rapid https://icmr.nic.in/sites/default/files/up 76-77 Antibody Kits for Covid-19 load_documents/Antibody_based_test on 16.04.2020 s_16042020.pdf 4. ICMR Protocol for using https://icmr.nic.in/sites/default/files/up 78-79 'Rapid antibody test' in Hot load_documents/Rapid_Antibody_test area - epidemiological studies _Protocol.pdf and surveillance E Administration 1. National Labs identified for https://icmr.nic.in/sites/default/files/w 80-83 COVID-19 testing to remain hats_new/National_Labs_identified_C open all 7 days a week OVID19_7days.PDF 2. MOHFW Depot List https://icmr.nic.in/sites/default/files/up 84-86 15.04.2020 load_documents/Revised_Depot_List_ 15042020.pdf 3. ICMR Regional Depots for https://icmr.nic.in/sites/default/files/up 87-96 storage and transportation of load_documents/Consolidated_depot_ COVID KITS 19.04.2020 information.pdf 4. ICMR Advisory for https://icmr.nic.in/sites/default/files/up 97 Procurement of Reagents for load_documents/Advisory_for_Reage Labs doing Real Time (RT)- nts_TestingLabs_v1.pdf PCR of Throat and Nasal Swab for diagnosis of COVID-19 5. ICMR Augmented Plan to https://icmr.nic.in/sites/default/files/up 98-125 fast track Covid-19 load_documents/Centres_of_Excellen Laboratory Scale up ce_for_Mentoring_Medical_Colleges. pdf 6. ICMR Guidance on https://stopcorona.tn.gov.in/wp- 126 expansion of SARS-CoV-2 content/uploads/2020/03/Revised- testing platforms Guidance-on-expansion-of-SARS- CoV-2-testing-platforms-07.04.2020- 1-Page-English-8-KB.pdf 7. ICMR List of VRDLs & https://icmr.nic.in/sites/default/files/up 127-138 their contact details load_documents/List_of_VRDL_V2.p df 8. ICMR guidance document https://icmr.nic.in/sites/default/files/up 139-142 for State Nodal VRDLs and load_documents/guidance_document_ testing VRDLs for n CoV for_State_Nodal_VRDLs_and_testing _VRDLs_for_nCoV_IP.pdf 9. Real Time PCR machines https://icmr.nic.in/sites/default/files/up 143 supplied to Government Labs load_documents/PCR_Machine_Locat ion.pdf 10. DMER Maharashtra 144-145 District wise Laboratory - Distribution 17.04.2020 11. DMER - Maharashtra