Ashok Rattan swine flu diagnosis

The First Choice Diagnostic Laboratory

Pandemic InfluenzaRole of Private Laboratories

Dr Ashok Rattan,Chief Executive,

Fortis Clinical Research Ltd.,Adviser,

Religare SRL Diagnostics,Fortis/ Escorts Hospitals,

Delhi & NCR


Pandemic InfluenzaInitial phase (June – July 2009)

• Infection of great Public Health Importance• Appropriate for Public Health Labs to deal

with diagnosis & confirmation– NICD and NIV designated by Govt as

Reference Labs.

• Private labs: – Vigilant Observations– Masterly inactivity (keep “the powder dry”)


3rd August 2009

• First death in Pune • Mass panic, public rush to hospitals, huge

lines, chaos (as seen on TV)• Public Health Labs overwhelmed with samples

& unable to cope• Private labs must come forward to help

– GGN SRL already works 24 x 7– Regularly receives, test & reports 250,000 samples

per month– Tie up with Lab India (authorized supplier in India for

ABI kits & Real Time PCR machines)


Diagnostic tests(review & selection of appropriate test)

• Viral Culture (too slow)• Lateral Flow for Seasonal Flu (not for swine flu)• FAT for Seasonal Flu (not for swine flu)• Real Time RT PCR

– Applied Biosciences Kit • (CDC/ WHO approved)• Used by Govt. Labs & selected for use in SRL

– Roche kits• Used by other private labs

– Primers for M2– Primers for H1


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 ORILI 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 casesORILI and has an epidemiologic link in the past 7 days to a confirmed case or probable case


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


Swine Flu Swine Flu H1 (N1 is associated)


Pandemic Flu diagnostics (Swine Flu) in SRL

• Home collection of samples by trained persons wearing single use appropriate PPE

• 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

• Use of Dacron swabs with plastic shafts for sample collection & placement into Viral Transport medium (+4 C)

• Safe & appropriate disposal of waste (after autoclave)• Use of VTM for sample collection & Safe Transportation• Transportation at 4 C to the lab (GGN or Mumbai)• Use of internationally validated primers and kits• Report to patient and public health authorities (soft copies)• Non exploitative & reasonable pricing of test & services• Experts available in GGN and Mumbai for follow up advice• Continuous improvement of TAT & processes


Interpretation of Real Time RT-PCR Swine Flu test

Seasonal Flu A

Swine Flu A

Swine H1 Rnase P Reportable results

+ + + + Swine Influenza H1N1 detected

+ -- -- + Seasonal Influenza A detected

2 out of 3 positive + Swine Flu (10% of samples)

-- -- -- + Seasonal Flu & Swine Flu

NOT detected

-- -- -- -- Inconclusive results due to specimen quality


Only Lab to obtain 100% concordanceIn PT samples supplied by NCDC


Day Wise Testing & Reporting (H1N1)From Gurgaon Reference Lab Date Total Accessioned Reports released Positive for swine flu

Between 20th & 24th August from NICD

379 342 (37 samples not in

appropriate conditions, so not tested)

46

28th Aug Written permission from Govt of Delhi obtainedSamples From Private patients collected from 29th Aug onwards

Date Total Accessioned Reports released Positive for swine flu

29.08.09 30 14 03

30.08.09 32 35 06

31.08.09 62 37 11

01.09.09 46 55 14

02.09.09 62 56 18

03.09.09 84 68 23

04.09.09 50 58 19

05.09.09 62 49 21

06.09.09 46 68 29

07.09.09 71 40 16

08.09.09 68 76 29

09.09.09 99 71 31

10.09.09 62 89 32

11.09.09 117 42 12


Seasonal & Swine Flu

Date Samples Reports Seasonal Swine17 sept 129 126 23 5516 124 126 18 4915 112 105 45 5314 131 87 23 2313 71 88 27 30

Both Seasonal & Swine flu appears to be spreading


Excellent team work in SRL

• Operations : Aparna , Anubhav, Rashmi• Sales & Marketing : Vinay Batra & team • HR, : Neeraj Goel• Engineering : Ravi Srivastava, Ashwini• Materials : Saurabh Chadha• Logistics : Rajib Guha, Pradeep Manual• IT : Biju T • Media : Ashish Ahuja• Administration : Sanjeev Issar• Collection centers• Patients & Clinicians• R & D : Dr B R Das• CEO : Dr SK Chaudhry

Technology

Ashok Rattan swine flu diagnosis