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ORIGINAL ARTICLE
Open Access

Realizing the “40 by 2022” Commitment From the United Nations High-Level Meeting on the Fight to End Tuberculosis: What Will It Take to Meet Rapid Diagnostic Testing Needs?

Amy S. Piatek, William A. Wells, Kaiser C. Shen and Charlotte E. Colvin
Global Health: Science and Practice December 2019, 7(4):551-563; https://doi.org/10.9745/GHSP-D-19-00244
Amy S. Piatek
aUnited States Agency for International Development, Washington, DC, USA.
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William A. Wells
aUnited States Agency for International Development, Washington, DC, USA.
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  • For correspondence: wwells{at}usaid.gov
Kaiser C. Shen
aUnited States Agency for International Development, Washington, DC, USA.
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Charlotte E. Colvin
aUnited States Agency for International Development, Washington, DC, USA.
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    TABLE 1.

    Baseline Model Parameters Needed to Calculate Xpert Cartridges and Modules to Identify 90% of Total Estimated TB Cases

    ParameterValue
    Estimated TB burden coverage90%
    Type of WRDXpert MTB/RIF
    Who receives a WRD?All with TB symptoms
    Number of adults with symptoms needed to test with WRD to diagnose one adult with TB10
    Number of children with symptoms needed to test with WRD to diagnose one child with TB4
    Number of days per year that WRD (module) is operational168
    Number of test cycles per day per module3
    Estimated percentage of PLHIV enrolled on ART81%
    TB screening visits per year for clients on ART2
    Percentage of clients on ART with symptoms that require WRD20%
    • Abbreviations: ART, antiretroviral therapy; PLHIV, people living with HIV; TB, tuberculosis; WRD, World Health Organization-recommended rapid diagnostic.

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    TABLE 2.

    Calculation Logic for Baseline Model

    Value to calculateComponents used in calculationFormulae used
    Total annual number of Xpert MTB/RIF tests = Number of tests for HIV+ adults, children, and HIV− adultsNumber of tests for HIV+ adultsEstimated number of PLHIVa · 81%b · 2c · 20%d
    Number of tests for childrenEstimated number of children with TBe · 90%f · 4g
    Number of tests for HIV− adultsNumber of TB patientse,h · 90%f · Percentage of TB patients who are adultse · Percentage of adults who are HIV−a · 10i
    Target number of Xpert modules neededTotal annual number of Xpert MTB/RIF tests/68j · 3k
    • Abbreviations: HIV+, HIV positive; HIV−, HIV negative; MTB, Mycobacterium tuberculosis; TB, tuberculosis; WRD, World Health Organization-recommended rapid diagnostic.

    • ↵a Source: Joint United Nations Programme on HIV/AIDS.

    • ↵b Target percentage of persons living with HIV who are enrolled on ART (90%· 90%).

    • ↵c Number of TB screening visits per year for clients on ART.

    • ↵d Percentage of clients on ART with symptoms that require testing with a WRD.

    • ↵e Source: World Health Organization.

    • ↵f Target for TB-burden coverage.

    • ↵g Number of symptomatic children needed to test with WRD to diagnose 1 child with TB.

    • ↵h All forms, including all incident, relapse, and previously treated.

    • ↵i Number of symptomatic adults needed to test with WRD to diagnose 1 adult with TB.

    • ↵j Number of days per year that WRD module is operational.

    • ↵k Number of test cycles per day per module.

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    TABLE 3.

    Xpert Modules and Test Cartridges Needed Under Baseline Model for 24 High-Burden Countries, by Country

    CountryCurrent Number of ModulesTotal Modules NeededChange Needed from Current (%)No. Test Cartridges (2017)No. Test Cartridges Needed, AnnuallyChange Needed from Current (%)
    Afghanistan1801,146537%17,500577,6003201%
    Bangladesh8606,229624%341,9003,139,400818%
    Cambodia300898199%134,050452,700238%
    Democratic Republic of the Congo6144,368611%32,3502,201,7006706%
    Ethiopia12683,111145%203,9501,567,700669%
    India478049,986946%2,543,15025,192,700891%
    Indonesia235614,545517%507,4507,330,8001345%
    Kenya8382,914248%450,4501,468,900226%
    Kyrgyzstan80167108%16,20084,000419%
    Malawi428873104%62,150440,100608%
    Mozambique3683,061732%150,2501,542,900927%
    Myanmar3673,120750%41,3001,572,4003707%
    Nigeria15768,182419%349,8504,123,5001079%
    Pakistan28089,087224%435,0504,579,900953%
    Philippines143610,029598%301,2005,054,5001578%
    South Africa42047,02767%2,198,0003,541,50061%
    Tajikistan12213813%133,15069,600−48%
    Tanzania8522,866236%395,2501,444,400265%
    Uganda9941,76277%300,850888,000195%
    Ukraine292725148%80,000365,200357%
    Uzbekistan208453118%76,100228,100200%
    Vietnam6902,230223%219,5001,124,000412%
    Zambia7201,19065%166,850599,700259%
    Zimbabwe5321,092105%247,900550,300122%
    TOTAL26,873135,198403%9,404,40068,139,600625%
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    TABLE 4.

    Sensitivity Analysis Relative to the Baseline Model

    Scenario NameParameter to ChangeDefault ValueEffect of Variation on Model Output
    1. Current notificationsEstimated TB burden90%If estimated TB burden is reduced to show only the capacity needed for current TB notifications, this will reduce the number of modules needed by a total of 32% (range: 8%–55%).
    2. Reduced TB prevalenceNumber of adults with symptoms needed to test with rapid diagnostic (Xpert) to diagnose 1 adult TB patient (NNT)10Number of needed modules changes almost proportionately (e.g., increasing to 12 tests will increase output by up to 19%). As prevalence decreases, the value will increase.
    3. More screening of PLHIVPercentage of PLHIV on ART with signs and symptoms of TB that require Xpert test20%Increasing the percentage to 30% will increase number of modules needed by a total of 6% (range: 0%–38%).
    4. Less screening of PLHIVDecreasing to 10% will decrease number of modules needed by a total of 6% (range: 0%–38%).
    5. Current screening of PLHIVDecreasing to 2.5% will decrease number of modules needed by an average of 10% (range: 0%–67%).
    6. Increased operation of moduleOperational capacity168 days/year
    3 cycles/day
    Increasing working days to 240 and test throughput to 4 cycles/day will reduce number of modules needed by 48% in all countries.
    7. CXR triageNumber needed to test10Including CXR as a triage tool before the WRD is estimated to reduce the number needed to test to 5 for HIV-negative adults and 2 for children, and to reduce the baseline number of PLHIV on ART requiring Xpert testing by 50%; in total, this would therefore reduce the number of modules and cartridges needed by 50%. See text for justification.
    8. Ambitious case findingNumber needed to test and operational capacity10 for NNT; 3 cycles/dayTo detect all people with TB, more ambitious case finding is needed. This is likely to result in both more down-time for modules (due to greater decentralization and/or using mobile screening, thus cycles/day is reduced to 2) and a lower positivity rate from testing more people with symptoms of TB (thus NNT is increased to 20). This combination of changes increases modules and cartridges needed by 177% and 84% (range: 80%–194% and 20%–96%).
    9. WRD sitesAccess standard for smear microscopyNoneConverts access standard for smear microscopy (1 microscope/100,000 population) to WRD sites needed to achieve same geographical coverage. This produces a large number of sites needed, though these values are more than 4 times lower than the baseline modules needed, since each site will require multiple modules to achieve sufficient throughput.
    • Abbreviations: CXR, chest X-ray; NNT, Number needed to test; PLHIV, people living with HIV; TB, tuberculosis; WRD, World Health Organization-recommended rapid diagnostic.

    • View popup
    TABLE 5.

    Cost Implications of Baseline Model (All Values in US$)

    CountryA: Cost of Additional Xpert Modules (Based on the Price of a 4-Module Instrument)B: Cost of 1 Year’s Supply of Additional Cartridges, According to Total Calculated NeedC: Total Incremental Cost of Baseline Model Over Current Situation (New Modules Plus 1 Year of Cartridges) (A+B)D: Total Current Cost (Existing Modules Plus Number of Cartridges Procured in 2017)E: Total % Increase in Investment Needed (C/D)
    Afghanistan$4,226,389$5,589,798$9,816,187$962,1501020%
    Bangladesh$23,489,236$27,919,050$51,408,286$7,174,662717%
    Cambodia$2,617,188$3,180,127$5,797,315$2,650,319219%
    Democratic Republic of the Congo$16,425,729$21,650,113$38,075,842$3,009,1031265%
    Ethiopia$8,061,007$13,610,225$21,671,232$7,582,921286%
    India$197,774,132$226,042,509$423,816,641$46,293,137916%
    Indonesia$53,327,917$68,097,033$121,424,950$15,371,851790%
    Kenya$9,084,618$10,164,131$19,248,749$8,161,741236%
    Kyrgyzstan$379,167$676,644$1,055,811$511,676206%
    Malawi$1,947,813$3,771,941$5,719,754$2,492,757229%
    Mozambique$11,783,229$13,898,647$25,681,876$3,109,495826%
    Myanmar$12,043,681$15,280,378$27,324,059$2,017,7991354%
    Nigeria$28,899,271$37,661,027$66,560,298$10,386,503641%
    Pakistan$27,471,076$41,365,603$68,836,679$16,626,799414%
    Philippines$37,593,368$47,437,934$85,031,302$9,288,476915%
    South Africa$12,349,688$13,408,130$25,757,818$40,328,54064%
    Tajikistan$70,417$(634,229)$(563,812)$1,862,587-30%
    Tanzania$8,810,694$10,470,517$19,281,211$7,672,095251%
    Uganda$3,359,583$5,859,757$9,219,340$7,351,233125%
    Ukraine$1,892,639$2,846,296$4,738,935$2,075,900228%
    Uzbekistan$1,070,035$1,516,960$2,586,995$1,669,478155%
    Viet Nam$6,738,194$9,026,910$15,765,104$5,209,360303%
    Zambia$2,055,729$4,319,843$6,375,572$4,815,163132%
    Zimbabwe$2,449,410$3,017,952$5,467,362$4,801,542114%
    TOTAL$473,920,208$586,177,296$1,060,097,504$211,425,287
    AVERAGE$19,746,675$24,424,054$44,170,729$8,809,387474%

Additional Files

  • Tables
  • Supplemental material

    • Supplement -

      Full Data on the Xpert MTB/RIF Module and Cartridge Needs Under the Sensitivity Analysis Scenarios

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Global Health: Science and Practice: 7 (4)
Global Health: Science and Practice
Vol. 7, No. 4
December 23, 2019
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Realizing the “40 by 2022” Commitment From the United Nations High-Level Meeting on the Fight to End Tuberculosis: What Will It Take to Meet Rapid Diagnostic Testing Needs?
Amy S. Piatek, William A. Wells, Kaiser C. Shen, Charlotte E. Colvin
Global Health: Science and Practice Dec 2019, 7 (4) 551-563; DOI: 10.9745/GHSP-D-19-00244

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Realizing the “40 by 2022” Commitment From the United Nations High-Level Meeting on the Fight to End Tuberculosis: What Will It Take to Meet Rapid Diagnostic Testing Needs?
Amy S. Piatek, William A. Wells, Kaiser C. Shen, Charlotte E. Colvin
Global Health: Science and Practice Dec 2019, 7 (4) 551-563; DOI: 10.9745/GHSP-D-19-00244
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