2014/05/05

1

Beyond Implementation:Health systems strengthening and

focus on high risk populations2011-2014

Professor Wendy Stevens

Department of Molecular Medicine and Haematology,

University of the Witwatersrand and

Head of National Priority Programs, NHLS

On behalf of the GeneXpert Team

TB Disease Burden in South Africa(WHO 2013 TB report)

• World’s 2nd highest incidence rate (1000/ 100 000/ year) (2012)

– Mining populations 4000/100,000:

– Correctional Services 4500/100,0000

• 63%-77% HIV prevalence in incident TB cases

• “Missed cases” remains a problem: (World’s 2nd highest in 2012)

• Increasingly smear negative

• South Africa reports the most XDR-TB cases in the world and annual

notifications have increased from 467 in 2009 to 1 596 in 2012. About 10% of

MDR-TB cases have XDR-TB

•WHO Strong Recommendation 2010: “The new automated DNA test for TB should be used as the initial diagnostic test in individuals with presumptive MDR-TB

or HIV/TB” (i.e. Most in SA)

•Pillars of SA National Strategic Plan: (2012-2016)•Minister of Health’s call in 2011

•Universal testing for HIV and screening for TB

South African experience highlighted areas for program strengthening

Priority Programs: general program: change from vertical management

•Linkage to care: CDC, BMGF, GF

•Focus on high risk populations: MDR, correctional services, mines

•Smooth implementation of EPTB and paediatric specimens

•R&D on other assays

Operational Challenges: Some solutions

•Improved technical and clinical training; Adherence

•Need for laboratory information systems to link with clinical data seamlessly

•Need for quality system components:

– Verification

– Remote monitoring; M&E for errors

– External quality assessment (pre – post analytical)

– Remote calibration

100% Coverage as per NDoH plan in public sector.

• Implementation in all original smear microscopy

centres: in a 3 phased approach, HBD first

• 207 centers across the 9 provinces

• Phased implementation started March 24th, 2011

• To date >3,2 mill tests performed to date; 60% of

global cartridges procured

• 289 analyzers: GX4 (95); GX16(186);GX48(1)

• 7 GX 80’s have been purchased and 5 installed to

improve capacity, but also assist with increased no's

expected for high risk populations

• 4th phase: High risk populations: correctional

services, mines and peri-mining communities and

MDR/XDR

Lab-based teaching

•916 technical staff trained

•3968 Clinical staff trained

•27 Master trainers for laboratories

•3 Master clinical trainers

Xpert contd…

2014/05/05

2

GeneXpert Cumulative data (March 2011-March 2014)

GeneXpert volumes, MTB detected: ~3.2 million tests to date (cumulative average 13% positivity) : geographical variation

Features:•Provincial summary District summary•Test volume trends MTB detected volumes (now at lab level)•Rif resistant volumes (now at lab level) Error rates•TATs Monthly uptake

GeneXpert volumes, RIF resistant (7%): stable average with geographic variation

GXP Test Volumes 2011-2014

0

50000

100000

150000

200000

250000

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

2011 3152 12920 15970 17989 19290 23912 26212 32002 32040 23452

2012 30961 36346 44854 36843 48581 53011 50174 57056 63394 83940 92918 62038

2013 90571 98228 116096 119537 154254 127508 182713 201202 194136 196844 185474 117490

2014 171834 155073 205140

No

. o

f Te

sts

GXP Volumes 2011-2013

Significant algorithm simplification requiredAdherence to laboratory algorithm

• Cumulative results: 41% (culture + LPA + indeterminate/no result)• Steady improvement in adherence to laboratory diagnostic algorithm (see slide 2)

• EXIT-RIF study: laboratory does not equate to those receiving treatment

Annual Algorithm data Note: steady increase in RIF resistance detection: 2011-2013

Reduction in culture usage in favour of LPA over time

Marked increase in RIF resistance detection in all 9 provinces over time

Algorithm adherence improves with time

South Africa: Notified cases of MDR-TB and enrolments on MDR-TB treatment 2009–2012 (WHO 2013 TB report)

• NOTIFIED CASES ;•2009: 9070

•2010: 7386

•2011: 10085•2012: 15419

• CASES ENROLLED ON MDR-TB TREATMENT:

•2009: 4143

•2010: 5402•2011: 5643

•2012: 6494

2014/05/05

3

Evaluation of the GenoType® MTBDRsl to screen for extensively drug-resistant tuberculosis in South Africa

Lynsey Stewart-Isherwood, Francesca Conradie, Kathryn Schnippel, Natalie Beylis, Riana Louw, Pamela Diniso, Amanda Axcell, John Dewar, Adriano Duse

Submitted to the Journal of Clinical Microbiology in April 2014

Setting: Dedicated drug-resistant tuberculosis (TB) hospital in South Africa.

Objective: To rapidly screen for XDR-TB within a high MDR-TB, HIV co-infected population.

Design: Prospective cohort of 150 newly admitted patients to Sizwe Hospital.

GenoType® MTBDRsl line probe assays (LPAs) were performed directly on sputum and indirectly on culture isolates for specimens collected at admission. Results

were compared to gold standard liquid culture and drug susceptibility testing (DST) for ofloxacin (OFX) and kanamycin (KAN).

Previous work in SA tested for OFX and Amikacin with good results, Barnard et al 2012

Specimen type n Prev (%) Sensitivity (%)

95% CI

Specificity (%)

95% CI

PPV (%)

95% CI

NPV (%)

95% CI

*OFX smear + 35 25.7 (12.5-

43.3)

100.0 (66.4-

100.0)

100.0 (86.8-

100.0)

100.0 (66.4-

100.0)

100.0 (86.8-

100.0)

*OFX smear - 19 10.5 (1.3-

33.1)

50.0 (1.3-98.7) 100.0 (80.5-

100.0)

100.0 (2.5-

100.0)

94.4 (72.7-99.9)

OFX culture 58 22.4 (12.5-

35.3)

100.0 (75.3-

100.0)

95.6 (84.9-

99.5)

86.7 (59.5-

98.3)

100.0 (91.8-

100.0)

*KAN smear + 35 11.4 (3.2-

26.7)

50.0 (6.8-93.2) 96.8 (83.3-

99.9)

66.7 (9.4-

99.2)

93.8 (79.2-99.2)

*KAN smear - 17 17.6 (3.8-

43.4)

33.3 (0.8-90.6) 92.9 (66.1-

99.8)

50.0 (1.3-

98.7)

86.7 (59.5-98.3)

KAN culture 58 12.1 (5.0-

23.3)

42.9 (9.9-81.6) 100.0 (93.0-

100.0)

100.0 (29.2-

100.0)

92.7 (82.4-98.0)

Summary of prevalence of XDR-TB, as well as the sensitivity, specificity, PPV and NPV of the GenoType® MTBDRsl assay, compared to phenotypic DST. (Sizwe Tropical Disease Hospital, Gauteng, South Africa)

*The predictive indices of the direct smear-positive and smear-negative LPA results should be considered with reservation, as the numbers in this study are small. A larger

study is required.

L.E. Isherwood, et al.Similar KAN from Ignatyeva et al

1. High Risk Populations: MDRWHO report 2013: Address MDR as a public health crisis

Large Linkage to Care Project:• Design a comprehensive real-time m-Health solution for linking patients to care

using electronic records and accessing the NHLS central data warehouse and

laboratory information system, as well as the Edr, Etr.net and clinical data system

from the NdoH.

• Two NHLS databases can be used: the Central Data warehouse (CDW) and the

Laboratory Information system to which all Xpert analysers are interfaced that is

responsible for delivery of results

• To get maximum usage out of newly designed bi-directional sms printers

• Secondary objectives

• To implement the reporting structure needed to facilitate linkage to the following stakeholders

– National reporting of R-R cases to the National TB program managers

– Regional reporting to Provincial co-ordinators

– Facility reporting to clinical manager

– Reporting to the closest MDR centre, patients they should be looking for

– Ensure all bi-directional printers are functional and distribution is completed.

– Engage contact and tracing teams being introduced by the National TB program

through global fund in collaboration with JHU

CDC funded labGF: JHU

Global interim fund

On the ground.....

Staff complement/target to be hired between all stakeholders:

•52 Linkage Officers: (1 per district)

•18 Project Directors: who will report to the Implementation Science

Director

•180 Nurses: trained to initiate and manage TB, MDR-TB and HIV and

care

•2500 PHC PN/EN teams

•104 Mobile infection/PHC re-engineering teams

•10,000 CHW/CCG (symptom screening, tracing, simple screening tool)

•18 PHC Master Mentors (4 KZN/3 EC/2WC/2NC/2GP/1FS/LM/MP/NW)

2014/05/05

4

Total DCS facilities- red

Total NHLS GXP labs (207)-green

Map of all DCS facilities and all NHLS GXP labs

• 150 000 defenders in 242 facilities in 48 management clusters

• 50 000 in remand

• Overcrowding, isolation difficult, workflow, connection to community

• NOT A CAPTIVE COHORT

• Comprehensive plan for managing HIV and TB in the Correctional

Management Centres in South Africa- programme launched on World

TB Day 2013 (guidelines, program initiated)

• National Task Team established by NPP with all stakeholders: NDoH,

DCS, Clinicians, NHLS, human rights and advocacy groups, facility

security, M&E group, research group, donors; infection control

• Several models for implementation proposed:

– Placement of GeneXpert at all 242 DCS facilities

– Placement at 7 larger DCS management facilities and incorporate other

centres into NHLS lab network

– Use existing NHLS lab network

2. Correctional services plan initiated

NHLS proposed project plan for 6 selected DCS

sites : Total:18,298; 9.6% MTB; 7.54% RIF Peri-Mining Communities-Pilot

• To improve TB diagnosis and treatment in six districts:

1. Lejweleputswa (Free State),

2. Dr. K Kaunda & Bojanala Districts (North West),

3. West Rand (Gauteng)

4. Waterberg & Sekhukhune (Limpopo)

1 mobile team in each district

HIV and TB: 2GX4

Impact studies

– XTEND: Aurum/BMGF funded/NHLS: cluster randomized trial Xpert testing

sites with/out Xpert to review cost-effectiveness and impact.

– X-Phactor: Xpert MTB/RIF for people attending HIV care: interventional

cohort study to guide rational implementation.

– EXIT-RIF: UNC, NC/RTC/WITS/NIH funded/NHLS: Observation study: Rif

resistant patients identified arm 1 by culture, arm 2 by Xpert

MSF: Implementing Xpert MTB/RIF in Zimbabwe (S. Van Den Broucke, IAS 2012):

•Xpert doubled detection rate;

•Increased the no. of lab confirmed TB cases- less empiric diagnosis of TB;

•Triples/quadruples the number of MDR –TB diagnosed

RTC in central Karoo region (T,van den Handel: personal communication):

•Xpert increased case detection

•Pre-Xpert: 22% cases treated were smear negative, culture negative vs. 1% post Xpert .

•Pre-Xpert 21% patients initiated in 5 days, post expert 95% initiated in 5 days.

2014/05/05

5

Optimizing the impact of Xpert MTB/RIF on

treatment outcomes of drug resistant TB

Evaluating the Xpert Impact on

Tuberculosis-Rifampicin Resistance

EXIT RIF Study

Annelies Van Rie, Lesley Scott, Yara Vossdelima,

Colleen Hanrahan, Natalie Beylis, Eugenne Elliott,

Cindy Hayes, Rob Warren, Wendy Stevens

Objectives

• To assess whether rapid diagnosis of RIF resistance leads to improved TB treatment outcomes.

• To determine phenotypic and genotypic drug resistance profile in patients diagnosed with Xpert-RIF resistance.

• To document management decisions and patient actions in the first 6 months following diagnosis of Xpert-RIF resistance.

Methods

• Study Design: Observational Cohort Study with two

arms.

• Sample size :474 total (237 per arm)

-One arm will be made up of individuals with RIF resistant TB by

culture-based drug susceptibility method or LPA on a sputum sample collected prior to TB treatment initiations

-The second arm will enrol individuals diagnosed with RIF resistant TB by Xpert MTB/RIF prior to the start of TB treatment.

-Enrolment period: 15 months. In Gauteng, Eastern Cape and Free State.

Embargo on results:Union meeting

Infinity installations

Sites

Province Laboratory Date

installed

Western Cape Greenpoint 18 Nov 2013

Free State Pelonomi 03 Dec 2013

Gauteng Tambo Memorial 03 Feb 2014

Gauteng Braamfontein 03 Apr 2014

Eastern Cape Port Elizabeth 17 Mar 2014

Gauteng CH Baragwanath Scheduled for

May

Gauteng Steve Biko To be re-

allocated

Challenges

• Infrastructural changes (Renovations)� Reinforcing door panels and floor

� Dedicated power points

� Redesigning of work area

� Removal of pipes (gas, water, waste, etc.)

� Crane required to lift machine

• LIS� Current barcodes too big causing

recurring gripper sensor problems – staff to manually cut

� New barcodes not compatible with TRAK-requires software modifications

Not a small endeavour…..

Pelonomi Laboratory; Free State

2014/05/05

6

Cost-effectiveness doesn’t equal affordability or uptake: linkage to care!

(Clouse, K et al, SAMJ 2012)

• Feasibility and impact of Gx at POC (~2hr test result).

– Concerns: Expanding Xpert to POC could result in important patient

benefits but requires substantial strengthening of primary care facilities

and investment in human resources (a minimum of two full-time staff

required to supervise sputum collection, process sputum, perform

assays, document and communicate results for an average of 15 TB

suspects daily). Some patients did not receive same day treatment due

to specimen preparation times.

Module Failures

Total Number of Modules Replaced: n=515 (of 3564)(14%)

Source of Error Frequency % No of

Sites

No of

Modules

Error Codes

Cartridge Related Issues 31 13.84 24 56 2037, 5011

Power Failure 7 3.13 6 13 2126, 4008

Sample Processing 38 16.96 27 69 2008, 5006, 5007, Invalid

Software Issues 5 2.23 3 9 2127, 4016

System Related Issues 72 32.14 59 130 1004, 1006, 1018, 2005, 2006,

2011, 2012, 2016, 2018, 2025,

2026, 2032, 2034, 2035, 4004,

4014

Temperature Related

Issues

71 31.70 44 128 1001, 1002, 2014, 2022, 4009,

4010, 4012, 4015, 4017

(n=405 attributed to module failure: 11.4%)

Summary of Module Failure errors

Cartridge

Relates Issues

14%

Power

Failure

3%

Sample Processing

17%

Software Issues

2%

Instrument Related Issues

32%Temperature Related Issues

32%Other

64%

• 89 (17%) were classified as calibration issues and 21 defective on installation (4%).

Most common: temperature fluctuations and instrument malfunction (63.95%)History of modules prior to replacement not known

• Costing and modeling revealed extended warranty costs 25% more than replacement

Dried culture spot program

• <3.5Ct SD across bulk batches

• <3.3Ct SD between skill cadres

• <3.3Ct SD between G3/G4

• Temperature stability: 4°°°°C to 37°°°°C (2.7Ct SD best at 37°°°°C)

• Stable to 12 months, therefore single shipment for whole year EQA (3/an)

One perforated DCS pushed out. Tested as a clinical specimen

Manufacture of bulk culture: single cell suspension

Manufacture of bulk culture: single cell suspension

Inactivation in Xpert SR buffer (2 hrs), confirmation by MGIT

Inactivation in Xpert SR buffer (2 hrs), confirmation by MGIT

Quantitfyusing flow cytometry: small particle counting (1um)

Quantitfyusing flow cytometry: small particle counting (1um)

Calculate bacterial events/ul

Calculate bacterial events/ul

Spot onto

Whatman

paper cards –

perforated

spots

Spot onto

Whatman

paper cards –

perforated

spots

Send to

sites for Gx testing

Send to

sites for Gx testing

US patent no: 8,709,712

Tbgxmonitor®

www.tbgxmonitor.com

info@tbgxmonitor.com

Trial outcomes:

• All material compatible with Gx testing.

– No PCR inhibition

• Matrix (liquid or dried) not a distinguishing criterion for

use.

• Some material required additional consumables, some

not easy to open, transfer to cartridge.

• Room temperature optimal for product stability and

transport: 4/5 panels pass.

• Minimal variation in Ct is optimal for future use of Gx

for patient monitoring: 3/5 panels pass

EQA trial: 5 materials,11 Gx site SAMaterial requirement for Gx platform:

•Material must contain whole M.tb

•Testing procedure safe and compatible with Gx

•Non-laboratory skilled HCW’s able to perform testingin non-lab settings.

•Easy to transport and stable during ranges oftemperature.

•Cost-effective and sustainable for large scale Nationalprograms.

In press, JCM, 2014

Upload results from laboratory

Central review and

release of reports

Automated Platform for result reporting:

www.tbgxmonitor.com• Submission of CSV files to cloud (web)

• Automated processing and analysis

• Review of results

• Issuing of report and soon IR (investigational report)

Upgrading for

automated frame

score report

2014/05/05

7

DCS EQA Overview

1. DCS panel2. Informatio

n3. SOP4. Barcodes

Panels 1, 2 & 3 packaged in

one shipment

Investigation Report

Tri-annual email reminder (automated)

TBGxMonitor.com+ = Performance Report

Tri-annual EQA Report based on all

sites

DCS material: single cell culture, inactivated, quantified,

spotted on perforated cards.

Frame score Report

Summary of all DCS performance : 2011-2014

EQA: 3 panels per year (4 DCS per panel)

• 2012:

– Pilot ACTG: 6 participants, verification of

instruments and trial of EQA program

– Pilot SA: 11 sites, DCS plus 4 other panels.

• 2013:

– ACTG: 20 sites (24 instruments) completed full EQA

program (16 instruments with passing frame score,

1 with acceptable frame score, 7 with a frame score

of concern)

– SA: Site participation increased by 40% from round

1 to 3: 202 sites, Timeous submission rates

improved 24% with total program costs <0.1% of

test cost; 2068 DCS analysed, 98% generated

correct results and 1% instrument/assay/operator

error.

• 2014

– South Africa: 207 sites

– ACTG: 19 sites (26 instruments) in 13 countries

– International participants: 21 sites in 6 countries

(Ghana, Uganda, Tanzania, Kenya, Nigeria, Namibia).

Verification: installation,

maintenance, calibration

• Completed all in SA: 3432

modules upon installation.

• Use for relocated instruments

• Field campaigns.

• GLI/WHO accepted DCS for

international Gx verification

– Cepheid accepts shared shipping with

their instruments

• DCS also tested on other

platforms:

– Abbott MTB (under R&D)

– Hain LPA V1, V2 (Durban TB

conference June 2014, oral)

– EasyNATTM(China) (ASLM Cape

Town, December 2014, under

submission)

Challenges and Solutions (2011-2014)

Early (2011) Solutions Mid (2012- current) Solutions

NTCM, National plan,

Treasury support

Donor and NdoH funding Module failures Replacement, work in progress,

history not known

Algorithm: dual Phased, unavoidable

HBD first

Non-adherence to diagnostic

algorithm

Improvement-20-41%

Stock shortages Stabilized

Global forecasting useful

Clinical data collection Poor; EXIT RIF study

Verification of analyzer on site DCS development; patent:

WHO/CDC approval

Clinical training: MDR especially Linkage to Care program:

Funded by CDC (NHLS, JHU,

NDoH)

EQA material Developed with DCS

Trialled in SA, ACTG

Extended warranty For SA EW was 30% more

expensive

Forecasting difficult in 2014; GF

projects delayed

Global forecasting Massive scale up of QA material

required

Business plan under review

Clinical lag in training Trainers employed by NHLS and

GF

EPTB: CSF, FNA, purulent fluid,

etc

In-country study, WHO meta-

analysis; SOPs and policy

developed

Instrument performance

monitoring

Remote connectivity system High risk populations: DCS,

mines, MDRInitiation pressure

Paediatric Policy developed, although

/with culture

Monopoly Pipeline improving

Investment not wasted with

new assays at Cepheid

Monopoly Pipeline improving

Current EPTB Recommendations• Consultation with the NPP as well as its Microbiology Expert Committee as to best

practice based on local data and WHO recommendations.

• In order to ensure best patient care it has been proposed that the following

extrapulmonary and paediatric sample types may be tested with the Xpert MTB/RIF

assay:

• Cerebrospinal fluid, fine needle aspirates, gastric washes and lavages, other

fluids and tissue. (SOP development for specimen type, MBD)

• The NHLS would like to propose a testing algorithm for the abovementioned sample

types that includes performing culture either as a reflex test or in parallel.

In general for extrapulmonary specimens:

• If the GeneXpert result is MTB detected and rifampicin sensitive, no further culture

testing is required

• If the GeneXpert result is MTB not detected, further testing with culture is required

• If the GeneXpert result is MTB detected and either rifampicin resistant or

indeterminate, further testing with culture is required

For all paediatric specimens: it is recommended to perform GeneXpert and culture in

parallel

Tissue samples will be sent only to culture facilities (16)

Additional EPTB specimens other than FNA: Xpert Validation, preliminary results (Aug – Jan2013):

(Elizabeth Prentice, Lesley Scott, Gloria Nkuna, Natalie Beylis, Wendy Stevens)

Contamination: NALC-NaOH

decontaminate

Residual Xpert tested: >0.5ml

N=6112 routine EPTB specimens received ~6 months

Blood agar plate check for contamination

No contamination

Inoculate MGIT (~0.5ml)

Exclusions:Numbers received in total <10 (0.6%)

Not enough residual for Xpert – needs to exceed 0.5 ml after routine processing (30%)

• Most common specimens excluded:• CSF (37%), • Pleural fluid (14%) • Other aspirates (9%)

•Blood (1%)

EPTB

Xpert testingAccuracy of the Xpert MTB/RIF assay for

diagnosis of HIV-associated peripheral

lymph node Tuberculosis (in press).Van Rie A, Page-Shipp L, Mellet K, Scott L, Mkhwanazi M, Stevens W,

Sanne I, Menezes CN.

•152 adults referred for FNA

•Detection: 20%(n=30) smear +, 45%(n=69)

culture +, 49%(n=76) Xpert +.

Miscellaneous

(sample types <5)

1%

Miscellaneous

(sample types <30)

2%Blood

1%

Tissue

2%

Ascitic

fluid

2%

Pus

4%

Fluid

5%

Aspirate

9%

Pleural fluid

10%

FNA

27%

Cerebrospinal

fluid

37%

EPTB specimen types received in a

high throughput central laboratory,

n=6112 received in 6 months (April 2012-Jan 2013

• Sensitivity (culture reference)

– Xpert 94.2% (85-98)

– Did not differ by smear status or CD4 count

• Median time to diagnosis: lymph node TB

– 5 days microscopy

– 31 days culture DST

• Median time to treatment initiation

– 1 day using Xpert

• Median time for Rif resistance diagnosis

– 1 day using Xpert

– 47 days using culture/MTBDRplus

2014/05/05

8

Findings

• Overall sensitivity of Xpert compared to

MGIT=55.9% (CI 48.8; 62.8)

• Absolute number: 159 new cases (18%

of total referrals)

• Cost-effective?

MGIT and

Xpert positive,

113, 13%

MGIT pos,

Xpert

Negative, 89,

10%

MGIT negative

Xpert positive,

46, 6%MGIT negative

, Xpert

negative, 524,

61%

MGIT

contaminated,

Xpert

negative, 70,

8%

MGIT

contaminated,

Xpert positive,

19, 2%

MGIT and Xpert positivity

35613

2125

39

68

363

2014

3228

96

11077

1115

28

0

20

40

60

80

100

120

MGIT and Xpert positivity per specimen type

Xpert positive (incl culture contaminated) Culture pos Cul contam

3632014

3228

96

346

1220

2232

60

0

20

40

60

80

100

120

140

160

180

Xpert positivty of MGIT

Cul pos Xpert pos

38%

53%41%

59%

38%

67% 40% 50%

Cepheid/NHLS Remote Connectivity project

• Operational

dashboard for

real-time

monitoring of

results, errors,

resistance and

positivity rates

• Pre-configured

on all newly

installed

GeneXperts

User Workshop held 5-9th November to improve usability and facilitate design changes, Johannesburg

Xpert Calibration

• Calibration cartridges as opposed to swap-out module.

• Run cartridge as a normal Xpert assay (21minutes)

• Software calibration is performed once the calibration file has been

verified by Cepheid

• Calibration activation code: barcode to be scanned in the calibration software to activate the calibration (within three months

of issuing)

• New version of calibration cartridge launched in December 2013 to reduce the number of calibration failures.

User runs calibration

software & loads the

calibration cartridges

Cepheid analyzes data

Activation code is provided

to user to update calibration

Certificate issued

Customer

Service notified

for follow-up

Data sent by internet or by CD

Courtesy FIND 201

5 cartridges

Pre-post calibrationCt value analysis

• Probe A evaluated:

– Ct decrease after calibration

– Less variability in Ct after calibration

– Not statistically significant (p=0.175)

• 2000 tests or 1 year may not be the optimal indicator for

calibration but rather change in SD of Ct value/module

• Concern: the use of Ct for patient monitoring?

0

5

10

15

20

25

30

35

Ct

va

lue

Module name

Pre and post calibration Ct for probe A: Instrument 1

Pre cal

Post cal

0

5

10

15

20

25

30

Ct

va

lue

Module name

Pre and post calibration Ct for probe A:

Instrument 2

Pre cal

Post cal

Pre

calibration post calibration

Instrument 1 (n=13)

Average Ct 18.5 17.9

SD 4.4 1.6

Instrument 2 (n=11)

Average Ct 19.3 17.4

SD 2.2 1.5

Xpert MTB/RIF field testing for NDoH campaign

and using DCS to verify mobile Gx units. World TB day: 10 X GX16 in mobile vehicles

w1

Slide 48

w1 didnt we use this last imewendy.stevens, 28/08/2012

2014/05/05

9

Acknowledgements• Honorable Minister of Health: Dr Motsoaledi

• NHLS National Priority Program staff : Dr Leigh Berrie, Mr Sebaka Molapo

• NDoH: Drs Mametje, Pillay, Mvusi, Barron. Mabope, Nshuti

• Centre for Tuberculosis: Drs N. Ismail. L.Erasmus

• CDC for funding and support

• HERO team, G. Meyer –Rath, K. Bistline, Prof S.Rosen, Dr Billl Macleod

• Right to care: Prof Ian Sanne

• MM&H: Prof Scott, N. Gous, B. Cunningham, Dr E.Prentice

• Centre for TB excellence: Dr Bavesh Khana

• NHLS TB Expert working group: Dr A Whitelaw, Prof M.Nichol

• USAID, South Africa

• FIND: new work on EQA, R&D projects: Heidi Albert, Dr Boehme

• Aurum Institute: Prof G Churchyard, XTEND study and staff

• Bill and Melinda Gates foundation

• PATH

• Cepheid for new collaboration: regarding remote calibrations and connectivity