1. A brief of Measles & Rubella
Surveillance- SGPGI Lucknow
Dr. Nikky N. Srivastava
Laboratory Supervisor
WHO-Polio & Measles and Rubella Surveillance
Department of Microbiology
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
2. Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, is a Super-Speciality Teaching and
Training Medical Institution, situated to the Southeast of Lucknow City on Lucknow-Raebareli Road, and is nearly
12 Km from the main (Charbagh) railway station, Lucknow Airport and city center (Hazratganj).
The institute employs over 250 faculty members across 32 departments. Each department consists of teaching,
training, patient care, and research. The Institute has 1609 beds, including 276 ICU and 87 HDU beds.
Sanjay Gandhi Post graduate Institute of Medical Sciences, Lucknow
3. The National Measles, Sanjay Gandhi PGI provides a valuable support to the National
Measles & Rubella Program in India since 2014 in the elimination initiative
This laboratory is the first one in the Global Measles Laboratory Network in terms of
largest number of Serum/Urine & throat samples processed each years.
Since 2014, our laboratory has achieved 100% in all the external proficiency panels
and maintained a very high level of reporting efficacy.
Although our journey was extremely difficult in Polio eradication, it taught us several
lessons that will stand us in good stead in future disease control/elimination efforts.
Millions of field & lab workers in UP and Bihar were crucial, to the successful
interruption of polio transmission in India. With the experience gathered from polio
eradication program we now aspire to put in our best efforts in Measles and Rubella
elimination as well.
Measles & Rubella Laboratory
4. 1. ELISA of Measles and Rubella virus from serum samples as per WHO
recommended algorithm in the state of Uttar Pradesh region.
2. Using standardized procedures and reagents;
3. Molecular detection of Measles and Rubella virus genotyping through RT-PCR from
Urine and throat samples as per WHO recommended protocol in the state of Uttar
Pradesh and Uttrakhand region.
4. All Positive DNA (PCR Product) send to NIV, Mumbai for sequencing.
5. Phylogenetic analysis for Measles and Rubella virus to identify the circulating
genotype in given time manner.
6. Submission of identified genotype in MeaNS and RubNS.
7. Reporting results to PROGRAME in giving timeliness
8. Coordination and implementation of containment activities
Responsibilities of SGPGI Lab in Global Lab
Network
5. National Polio and Measles & Rubella Laboratory
Department of Microbiology
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
6.
7. Activities
Serology (IgM ELISA) test started Since December 2013
The confirmatory test for Measles and Rubella IgM detection at KIPM, Chennai is being
conducted since 2014
2022
Measles:100 %
Rubella: 100%
2023
Measles:100 %
Rubella: 100%
Implementation of Internal quality control (IQC) including monitoring of kit lot variation by
in-house control
In present performing from KIPM
Chennai received IQC
Timeliness of Measles and Rubella IgM ELISA report within 4 days
2021
Measles: 99.76
Rubella: 97.8
2022
Measles: 99.10 %
Rubella: 96.67 %
The last annual on-site accreditation review done by Dr. Deepa, NPO, NPSU and Dr. Nibedita
Das, Serology Institute of Kolkata
Accredited ( > 90%)
Official result awaited
SGPGI was recognized for molecular testing on throat swab/urine samples
for measles and rubella virus
Since November 2014
Phylogenetic analysis of Measles and Rubella through Gene studio and Recall Since 2019
Submission of genotype in MeaNS and RubNS Since 2015
Annual Internal audit done for M&R Surveillance Since 2017
Measles & Rubella Surveillance Activities
8. Weekly Workload 2022 in SGPGIMS Laboratory
SGPGI Laboratory
status (01-01-2022 –31-12--2022
Total samples Received =15449
Total Serum =9467
Total Urine =60
Total Throat = 5852
Total Nasophyaryngeal Swab=70
*Data as on 03-05-2023
9. Weekly Workload 2023 in SGPGIMS Laboratory
SGPGI Laboratory
status (01-01-2023 –30-04-2023
Total samples received=11593
Total Serum =6905
Total Urine =13
Total Throat = 4661
Total Nasophyaryngeal Swab=14
*Data as on 03-05-2022
11. Measles Rubella
Total
Tested
Samples
Timeliness
within 4
days
(%)
Total
Tested
Samples
Timeliness
within 4 days
(%)
2018 3211 **26.47 1444 **18.07
2019 1943 85.79 1765 65.89
2020 1273 98.37 1198 90.17
2021 5579 99.76 5230 97.8
2022 9467 99.10 7612 96.67
* 2023( till March )
4808 ** 65.64 2221
**58.03
5 Years timeliness data for Measles & Rubella ELISA
(Serology)
* Data as on 1st May 2023
** The timeliness has been decreased due to globally shortage of kits.
12. Result of Recent Proficiency tests
Date of receipt of panel 01-01-2022
Date of report 01-03-2022
Score Measles RT-PCR 100%
Score Rubella RT-PCR 100%
Date of receipt of panel 21-01-2023
Date of report 31-01-2023
PI Score 100%
Global -Measles & Rubella
ELISA Panel-2023
Global -Measles and Rubella
Molecular Panel-2022
Date of receipt of panel 01-04-2022
Date of report 13-04-2022
PI Score 100 %
National PT-Panel Measles & Rubella
ELISA Panel-2022
Global -Measles and Rubella
Molecular Panel-2023
Date of receipt of panel 21-01-2023
Date of report 15-03-2023
Score Measles RT-PCR Result awaited
Score Rubella RT-PCR Result awaited
13. Measles – Internal Quality Control (LJ) Chart-
2021-2022
2.031
1
1.2
1.4
1.6
1.8
2
2.2
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63
Chart Title
Lot. No. Kit ---> Date test ---> Lab ref. Pos.
Standard Mean Standard Mean-SD Standard Mean+SD
Standard Mean-2SD Standard Mean+2SD Standard Mean-3SD
14. Rubella – Internal Quality Control (LJ) Chart-
2021-2022
2.346
1.5
1.7
1.9
2.1
2.3
2.5
2.7
2.9
1 2 3 4 5 6 7 8 9 1011121314151617181920212223242526272829303132333435363738394041424344454647484950515253545556575859606162
Chart Title
Lot. No. Kit ---> Date test ---> Lab ref. Pos. Standard Mean
Standard Mean-SD Standard Mean+SD Standard Mean-2SD Standard Mean+2SD
Standard Mean-3SD Standard Mean+3SD
17. S. No Name of Equipment's PM/ AMC Service Provider Model No. Serial No. Equipment S No
AMC Services Duration
From
To
1 Deep Freezer - 800
C M/s National Scientific Promoter 994 Upright Double Door LT823416-01560 WHO-NPSP/212/2011 01.08.2022 31.07.2025
2
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. SG403A-74914 74914 NPSP/WHO/87/2002 01.08.2022 31.07.2025
3
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. SG403-74925 74925 NPSP/WHO/88/2002 01.08.2022 31.07.2025
4
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. SG403MOD-85459 85459 NPSP/WHO/129/2005 01.08.2022 31.07.2025
5
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. 96757 SG403A(71112U001) WHO-NPSP/158/2009 01.08.2022 31.07.2025
6
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. 98592 SG403-98592 WHO-NPSP/164/2009 01.08.2022 31.07.2025
7
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. 103222-A SG40A-HE-INT-103222-A WHO-NPSP/207/2011 01.08.2022 31.07.2025
8
Biohazard Safety Cabinet
M/s Mehrotra Biotech (P) Ltd. 103222-B SG40A-HE-INT-103222-B WHO-NPSP/208/2011 01.08.2022 31.07.2025
9 PCR Machine M/s Vision Diagnostic Pvt. Ltd. ProflexTM
297807976 WHO/NPSP/279/2017 01.09.2022 31.08.2025
10 Real Time PCR Machine M/s Vision Diagnostic Pvt. Ltd. 7500 2750010351 WHO/NPSP/268/2016 01.09.2022 31.08.2025
11
Water Purification System M/s Reliable Instrument Co. Haryana M/s Reliable Instrument Co. Haryana Integarate NPSP/WHO/192/2010
01.04.2022 31.03.2025
12 Refrigerated Centrifuge (Mixer) M/s Eppendorf India Ltd, Chennai 5417 8175 WHO-NPSP/61/2000 01.07.2023 30.06.2026
13 Refrigerated Centrifuge M/s Eppendorf India Ltd, Chennai 5810R (Z421262L) 5811ZL64631 WHO-NPSP/179/2010 01.07.2023 30.06.2026
14 Elisa Reader M/s National Scientific Promoter Multiskan FC 375-703865T WHO-NPSP/160/2022 Machine under warranty till June 2023
15 Hot Air Oven M/s National Scientific Promoter DKN 912 44400381R WHO/NPSP/131/2005 01.09.2022 31.08.2023
16 Elisa Washer M/s National Scientific Promoter Well Wash 4MK2 888-69818 WHO-NPSP/161/2021 Machine under warranty till Feb 2023
17 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. F0000004A0155328 1817523015A5 WHO-NPSP-150-DFH 01.07.2023 30.06.2026
18 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 2B000004A008DB28 1817523018A7 WHO-NPSP-151-DFH 01.07.2023 30.06.2026
19 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 03000005158F1228 1817523016A5 WHO-NPSP-111-DFH 01.07.2023 30.06.2026
20 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 5400000515F73428 1.81752E+11 WHO-NPSP-236-DFH 01.07.2023 30.06.2026
21 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 6A0000049F885D28 18175230189D WHO-NPSP-238-DFH 01.07.2023 30.06.2026
22 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. AC00000480483A28 1817523015A8 WHO-NPSP-240-DFH 01.07.2023 30.06.2026
23 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 6D0000048047CE28 1817523016AA WHO-NPSP-193-DFH 01.07.2023 30.06.2026
24 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 1A00000480069228 1.81752E+11 WHO-NPSP-235-DFH 01.07.2023 30.06.2026
25 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. 890000047FCCFD28 1817523018A1 WHO-NPSP-234-DFH 01.07.2023 30.06.2026
26 Cobalt Data Loggers M/s Lisaline Lifescience Techn. Pvt. Ltd. CA00000515E96628 1817523016B7 WHO-NPSP-239-DFH 01.07.2023 30.06.2026
18. Calibration of Equipment's
Name of Equipment Company Name Nos. Calibration Date Calibration Due
Date
Bio-Safety Cabinet M/s Quality Services & Laboratories 10 30.03.2023 29.03.2024
Real Time PCR Machine
RT-PCR machine (Proflex)
M/s Vision Diagnostic Pvt. Ltd. 2
1
18.02.2023 18.07.2023
Micro Centrifuge Machine Ms Eppedroff India Pvt. Ltd. 3
File under administrative process for agreement
of AMC
Micropipette Quality Services & Laboratories 20 25.04.2023 25.10.2023
Weighing Machine Need to replaced
Thermometer/
Data Logger
M/s Lisaline Life science Tech. Pvt. Ltd. 10 07.09.2022 07.09.2023
ELISA Reader & Washer M/s National Scientific Promoter 1 10.04.2023 10.09.2023
19. Maintenance of Record of Measles & Rubella
Surveillance
1. SOP of Measles & Rubella Surveillance
2. Manual ELISA Worksheet
3. Electronic ELISA worksheet for Measles
4. Electronic ELISA worksheet for Rubella
5. Manual Inventory of Serum samples
6. Electronic Inventory sheet for Serum Samples
7. RT-PCR worksheet file for Measles
8. RT-PCR-Worksheet for Rubella
9. IQC file
10. Re Confirmatory test for cross validation file
11. Shipment of PCR Product
12. LRF/Positive LRF
13. Sequencing record of MeaNs and RubNS
14. Proficiency Panel for ELISA
15. Proficiency Panel for RT-PCR
16. Internal audit report and onsite Accreditation Checklists
17. Vaccine Record of Staff
18. Internal Pipette calibration file
19. Training File
20. External calibration of Pipette
21. External calibration of Bio safety cabinet file
22. Kit Inventory file for ELISA
23. Kit Inventory of RT-PCR
24. CAPA
20. Action taken report of previous recommendation of Onsite audit
accreditation- 12th to 14th September 2022
Recommendation Status Remark
• SOP’s are appropriate but need revision especially for
data entry and reporting, serology algorithm etc.
Done
• Document control related to SOP like master copy,
control copy needs to be implemented.
Done
• Laboratory lay out was available but need distinction
indicating infectious, non-infectious area, exit marking.
Done
• Laboratory need to rearrange the section for waste
disposal and receipt of specimen as separate facility
within the laboratory.
Area for waste disposal has been
assigned but receiving section has not
been shifted yet.
Due to increase in Covid-
19 positivity, Institute has
not given approval yet.
• Laboratory need to change in phase-wise manner the lab
furniture with stainless steel material which is
requirement of virology laboratory.
Institute procured lab chair
received
General
Continued
21. • Weighing balance need to be made available as
existing one is non-repairable
Lot of times indent done but
Not received from WHO till
now
• ELISA IgM kits must have date of receipt marked. Already done
• High-capacity autoclave is required urgently for Bio-
waste management as laboratory is having very high
workload of polio and MR and no backup autoclave
available in the facility.
One backup autoclave has been
received from Institute and their
installation has been done
• All the staff needs to be vaccinated for Hepatitis B
vaccine.
•
Done
• Emergency phone numbers to be displayed in the
laboratory.
Already displayed
• Fans should be removed from each room in the
laboratory
Fans have been disconnected.
Continued
22. Recommendation Status Remark
• New lot of LQC (2022 lot) to be used for both Measles
and Rubella testing. Any discrepancy in the LJ chart to
be followed up with a CAPA and information to WHO
and KIPM, Chennai
Done
• For rubella LQC, the laboratory is requested to contact
reference laboratory KIPM, Chennai and assign new
range for LQC values with their concurrence
The new IQC has been received on 05-
05-2023
• A new electronic balance is required and the old one is
beyond repair
Lot of times indent done but Not
received from WHO till now.
• Samples sent for revalidation to be double checked so
that 100% concordance can be achieved.
Suggested protocol has been
implemented and 100% concordance
has been achieved this year.
Serology –
Continued
23. Recommendation Status Remark
• Shifting of Environmental sewage processing unit
besides the Amplification room to another place.
Already shifted
• Labelling of infectious and non-infectious
refrigerators and freezers.
Done
• Storing and transfer of bio-waste from the lab must
be modified. The waste should be carried using
trolleys and storage to be done in closed containers.
Trolley and weighing machine has
been purchased and waste
management area has been
modified
• Although one staff is being trained for Measles and
Rubella molecular testing two more staff need to be
trained for the same. Two more staff need to be
trained for phylogenetic analysis and submission in
MeaNS and RubeNS.
Two additional staffs have been
trained in molecular testing and
phylogenetic analysis
Phylogenetic analysis
done through virtual
webinar organised by
WHO.
Virology –
24. Laboratory Challenges
Lack of Man power is a challenge.
Huge Documentation
Lack of space in deep freezer (Urgent requirement of -800)
Equipment Maintenance
Frequently breakdown of old equipment
Timely supply of kit and reagents
Maintaining the Timeliness . surveillance :
ELISA - Anticipated Work load
A part from this we are very thankful to the microbiology department for their enormous support to our surveillance
A brief introduction to the measles and rubella laboratory at a glance
Now we discuss the
As we can see the a the entire schematic diagram of physical lab lay out of Polio & MR Surveillance.
Now we can see the Organogram of Measles & Rubella Surveillance
Here we can see the Firstly Dr Atul Garg recently joined as a Principal investigator in April 2023, and Incharge of laboratory
Myself incharge of all activities.
The activities that we following in the M&R surveillance as follows;
Here we can see the increased in the sample load that is nearly doubled since week no. 4.
In 2022 we have processed 15449 samples and out of which measles positivity as reported 19.59 % in serology.
We
Here we can see the list of equipments which are under AMC from certified company
This is the present status of calibrated equipment list
Here we can see the list of documents which are maintaining in the laboratory
A part of being a well established laboratory still we have faced many challenges such as:
