Ashok Rattan swine flu diagnosis


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Role of private labs in diagnosis of Swine Flu

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Ashok Rattan swine flu diagnosis

  1. 1. Pandemic Influenza Role of Private Laboratories Dr Ashok Rattan, Chief Executive, Fortis Clinical Research Ltd., Adviser, Religare SRL Diagnostics, Fortis/ Escorts Hospitals, Delhi & NCR
  2. 2. Pandemic Influenza Initial phase (June – July 2009) <ul><li>Infection of great Public Health Importance </li></ul><ul><li>Appropriate for Public Health Labs to deal with diagnosis & confirmation </li></ul><ul><ul><li>NICD and NIV designated by Govt as Reference Labs. </li></ul></ul><ul><li>Private labs: </li></ul><ul><ul><li>Vigilant Observations </li></ul></ul><ul><ul><li>Masterly inactivity (keep “the powder dry”) </li></ul></ul>
  3. 3. 3 rd August 2009 <ul><li>First death in Pune </li></ul><ul><li>Mass panic, public rush to hospitals, huge lines, chaos (as seen on TV) </li></ul><ul><li>Public Health Labs overwhelmed with samples & unable to cope </li></ul><ul><li>Private labs must come forward to help </li></ul><ul><ul><li>GGN SRL already works 24 x 7 </li></ul></ul><ul><ul><li>Regularly receives, test & reports 250,000 samples per month </li></ul></ul><ul><ul><li>Tie up with Lab India (authorized supplier in India for ABI kits & Real Time PCR machines) </li></ul></ul>
  4. 4. Diagnostic tests (review & selection of appropriate test) <ul><li>Viral Culture (too slow) </li></ul><ul><li>Lateral Flow for Seasonal Flu (not for swine flu) </li></ul><ul><li>FAT for Seasonal Flu (not for swine flu) </li></ul><ul><li>Real Time RT PCR </li></ul><ul><ul><li>Applied Biosciences Kit </li></ul></ul><ul><ul><ul><li>(CDC/ WHO approved) </li></ul></ul></ul><ul><ul><ul><li>Used by Govt. Labs & selected for use in SRL </li></ul></ul></ul><ul><ul><li>Roche kits </li></ul></ul><ul><ul><ul><li>Used by other private labs </li></ul></ul></ul><ul><ul><ul><ul><li>Primers for M2 </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Primers for H1 </li></ul></ul></ul></ul>
  5. 5. Case Definitions for Infection with Novel Influenza A (H1N1) Virus A confirmed case of novel influenza A (H1N1) virus infection is defined as a person with an influenza-like illness with laboratory confirmed novel influenza A (H1N1) virus infection by one or more of the following tests: real-time RT-PCR viral culture A probable case of novel influenza A (H1N1) virus infection is defined as a person with an influenza-like-illness who is positive for influenza A, but negative for human H1 and H3 by influenza RT_PCR Optional A suspected case of novel influenza A (H1N1) virus infection is defined as a person who does not meet the confirmed or probable case definition, and is not novel H1N1 test negative, and is/has: a previously healthy person < 65 years hospitalized for ILI OR ILI and resides in a state without confirmed cases, but has traveled to a state or country where there are one or more confirmed or probable cases OR ILI and has an epidemiologic link in the past 7 days to a confirmed case or probable case
  6. 6. RNAse P for adequacy of sample Human Influenza A SRL uses ABI kit with four sets of primers, this kit is recommended by CDC / WHO
  7. 7. Swine Flu Swine Flu H1 (N1 is associated)
  8. 8. Pandemic Flu diagnostics (Swine Flu) in SRL <ul><li>Home collection of samples by trained persons wearing single use appropriate PPE </li></ul><ul><li>Protection of sample collector by wearing appropriate Personal Protective Equipments (PPE) single use, which is then also send in Red waste collection bag to lab for autoclave & disposal </li></ul><ul><li>Use of Dacron swabs with plastic shafts for sample collection & placement into Viral Transport medium (+4 C) </li></ul><ul><li>Safe & appropriate disposal of waste (after autoclave) </li></ul><ul><li>Use of VTM for sample collection & Safe Transportation </li></ul><ul><li>Transportation at 4 C to the lab (GGN or Mumbai) </li></ul><ul><li>Use of internationally validated primers and kits </li></ul><ul><li>Report to patient and public health authorities (soft copies) </li></ul><ul><li>Non exploitative & reasonable pricing of test & services </li></ul><ul><li>Experts available in GGN and Mumbai for follow up advice </li></ul><ul><li>Continuous improvement of TAT & processes </li></ul>
  9. 9. Interpretation of Real Time RT-PCR Swine Flu test Inconclusive results due to specimen quality -- -- -- -- Seasonal Flu & Swine Flu NOT detected + -- -- -- Swine Flu (10% of samples) + 2 out of 3 positive Seasonal Influenza A detected + -- -- + Swine Influenza H1N1 detected + + + + Reportable results Rnase P Swine H1 Swine Flu A Seasonal Flu A
  10. 10. Only Lab to obtain 100% concordance In PT samples supplied by NCDC
  11. 11. Day Wise Testing & Reporting (H1N1) From Gurgaon Reference Lab 12 42 117 11.09.09 32 89 62 10.09.09 31 71 99 09.09.09 29 76 68 08.09.09 16 40 71 07.09.09 29 68 46 06.09.09 21 49 62 05.09.09 19 58 50 04.09.09 23 68 84 03.09.09 18 56 62 02.09.09 14 55 46 01.09.09 11 37 62 31.08.09 06 35 32 30.08.09 03 14 30 29.08.09 Positive for swine flu Reports released Total Accessioned Date 28 th Aug Written permission from Govt of Delhi obtained Samples From Private patients collected from 29 th Aug onwards 46 342 (37 samples not in appropriate conditions, so not tested ) 379 Between 20 th & 24 th August from NICD Positive for swine flu Reports released Total Accessioned Date
  12. 12. Seasonal & Swine Flu <ul><li>Date Samples Reports Seasonal Swine </li></ul><ul><li>17 sept 129 126 23 55 </li></ul><ul><li>124 126 18 49 </li></ul><ul><li>15 112 105 45 53 </li></ul><ul><li>14 131 87 23 23 </li></ul><ul><li>13 71 88 27 30 </li></ul>Both Seasonal & Swine flu appears to be spreading
  13. 13. Excellent team work in SRL <ul><li>Operations : Aparna , Anubhav, Rashmi </li></ul><ul><li>Sales & Marketing : Vinay Batra & team </li></ul><ul><li>HR, : Neeraj Goel </li></ul><ul><li>Engineering : Ravi Srivastava, Ashwini </li></ul><ul><li>Materials : Saurabh Chadha </li></ul><ul><li>Logistics : Rajib Guha, Pradeep Manual </li></ul><ul><li>IT : Biju T </li></ul><ul><li>Media : Ashish Ahuja </li></ul><ul><li>Administration : Sanjeev Issar </li></ul><ul><li>Collection centers </li></ul><ul><li>Patients & Clinicians </li></ul><ul><li>R & D : Dr B R Das </li></ul><ul><li>CEO : Dr SK Chaudhry </li></ul>