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Onchocerciasis ONCHOCERCIASIS GUIDELINES FOR STOPPING MASS DRUG ADMINISTRATION AND VERIFYING ELIMINATION OF HUMAN ONCHOCERCIASIS CRITERIA AND PROCEDURES ANNEXES − Annex 1. Key questions Key question 1 Which test (and at which threshold and time-point) can be used to demonstrate interruption of transmission of onchocerciasis (and therefore stop ivermectin administration)? Test Threshold Time point O-150 PCR in black flies (head) < 1/1000 (0.1%) parous Peak transmission flies or < 1/2000 (0.05%) in season all flies assuming a 50% parous rate. A 95% CI will be used. PCR in black flies (body) Optional, but protocol calls Peak transmission for switching to testing season heads at first positive pool Ov-16 serology in children (< 5 y) < 0.1% (CI: 95%); has been operationalized in children < 10 y Ov-16 serology in children (< 10 y) < 0.1%. A 95% CI will be In same quarter of used. year as flies are collected Annual biting rate NA (taken into account in Poolscreen) Annual transmission potential < 20. A 95% CI will be used Calculated from flies collected during peak transmission season as above for PCR Skin snips (microscopic evaluation) NA Skin snips (PCR) Only done on those As soon as possible children who test OV-16 after serological positive results are known DEC test (patch) NA DEC test (oral, Mazzotti test) NA Ultrasonography NA Antigen testing (dipstick for urine or tears) NA CI, confidence interval; NA, not applicable; Ov-16, IgG4 antibodies against Onchocerca volvulus 16 antigen; PCR, polymerase chain reaction; y, years 1 − Key question 2 Which test (and at which threshold and time-point) can be used to demonstrate elimination of onchocerciasis? Test Threshold Time point O-150 PCR in black flies (head) < 1/1000 (0.1%) parous Peak transmission flies or < 1/2000 (0.05%) in season 3 years after all flies assuming a 50% cessation of MDA parous rate. A 95% CI will be used. PCR in black flies (body) See above Ov-16 serology in children (< 5 y) See note above Ov-16 serology in children (< 10 y) < 0.1%. A 95% CI will be Optional but at end used of 3–5-year PTS Annual biting rate NA Annual transmission potential < 20. A 95% CI will be used Calculated from flies collected as above for PCR Skin snips (microscopic evaluation) NA Skin snips (PCR) NA unless serology tested Optional but at end as option; only seropositive of 3–5-year PTS children would be snipped and tested DEC test (patch) NA DEC test (oral, Mazzotti test) NA Ultrasonography NA Antigen testing (dipstick for urine or tears) NA CI, confidence interval; DEC, diethylcarbamazine citrate; Ov-16, IgG4 antibodies against Onchocerca volvulus 16 antigen; PCR, polymerase chain reaction; y, years Other specific questions for panel experts Does it make sense to combine all populations worldwide (no – this will likely proceed as regional elimination for some time) or should we split the populations, for example: ▬ the general population of countries/regions of the Americas? Yes, this has been done as the foci in the Americas are very distinct and separate from each other with the exception of the one focus in the Yanomami Indians that is a cross border focus with the Bolivarian Republic of Venezuela and Brazil. ▬ the general population of countries/regions of Africa? In Africa, because a number of the foci (or transmission zones) are cross border and there will be fly movement within the zone, it will be necessary to validate that transmission has been interrupted in one or more countries before that region can undergo verification. The risk of reintroduction is also higher in the Africa setting and this will have to be taken into consideration. ▬ other countries/regions? 2 − Can you give us any other feedback on the use of tests for onchocerciasis that may be difficult for us to obtain from the literature? For example: ▬ on the “gold standard”? This will most likely have the key words of “PCR on black flies” or “PoolScreen”. For serology, it is likely that most will have the key word “Ov- 16”, but could also simply use “serology”. ▬ on the timing of tests? This will come mostly from those published studies documenting interruption of transmission in specific foci, or the one article Guide to detecting a potential recrudescence of onchocerciasis during the post-treatment surveillance period: the American paradigm.1 ▬ in relation to the history of use of a test or the background of its development? Do you have any other comments or feedback for us? 1 Guide to detecting a potential recrudescence of onchocerciasis during the post-treatment surveillance period: the American paradigm. Res Rep Trop Med. 2012;3:21–33. doi.org/10.2147/RRTM.S30482. 3 − − Annex 2. Summary of the evidence Table of contents 1 Executive Summary ......................................................................................................................... 4 2 Background ...................................................................................................................................... 5 2.1 Purpose of this supporting document ..................................................................................... 5 3 Methods .......................................................................................................................................... 5 3.1 Topic refinement and review protocol .................................................................................... 6 3.2 Key questions & analytic framework ....................................................................................... 6 3.3 Search strategy ........................................................................................................................ 8 3.4 Eligibility criteria ...................................................................................................................... 8 3.4.1 Population / setting ......................................................................................................... 9 3.4.2 Intervention (diagnostic tests) ........................................................................................ 9 3.4.3 Control (DTA reference standard or other test) .............................................................. 9 3.4.4 Outcomes & study designs .............................................................................................. 9 3.5 Study selection ...................................................................................................................... 10 3.6 Data extraction & risk of bias assessment............................................................................. 11 3.7 Data synthesis........................................................................................................................ 12 3.8 Quality of body of evidence .................................................................................................. 12 4 Results ........................................................................................................................................... 13 4.1 Results of literature searches ................................................................................................ 13 4.2 Key points .............................................................................................................................. 14 4.2.1 Summary of available evidence ..................................................................................... 14 4.2.2 Summary of findings ...................................................................................................... 15 4.3 Description of included studies ............................................................................................. 16 4.4 Detailed Synthesis ................................................................................................................. 25 4.4.1 Evidence for clinical pathway (overarching KQ1 & KQ2) .............................................. 25 4.4.2 Evidence from diagnostic studies for KQ1 & KQ2 ......................................................... 31 4.5 GRADE profiles ...................................................................................................................... 35 4.5.1 Evidence for clinical pathway (overarching KQ1 & KQ2) .............................................. 35 4.5.2 O-150 PCR of skin snips (index test) vs. skin snip microscopy (reference test) ............ 37 4.5.3 Ov-16 serology (index test) vs. skin snip microscopy (reference test) .......................... 38 4.5.4 O-150 PCR [Poolscreen] (index test) vs. dissection of black flies (reference test) ........ 39 5 References ..................................................................................................................................... 40 6 Appendix A: Search Strategy ......................................................................................................... 44 7 Appendix B: Excluded studies at fulltext review level ................................................................... 49 7.1 Ineligible outcome (n=51) ..................................................................................................... 49 7.2 Ineligible population(s) (n=4) ................................................................................................ 52 7.3 Ineligible publication type (n=4) ............................................................................................ 52 7.4 Ineligible or no diagnostic test (n=65) ................................................................................... 53 7.5 Ineligible comparisons
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