Point of care rapid test for diagnosis of syphilis infection in men and nonpregnant women
Appendices
Appendix 1. Search Strategies
MEDLINE and CENTRAL search strategy (OVID platform)
1 exp Point‐of‐Care Testing/
2 'point of care'.tw.
3 (bedside adj5 test$).tw.
4 poc.tw.
5 poct.tw.
6 (rapid adj5 test$).tw.
7 (self adj5 test$).tw.
8 (self adj5 collect$).tw.
9 (self adj5 swab$).tw.
10 (syphilis adj5 rapid adj5 test).tw.
11 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10
12 exp Treponema pallidum/
13 treponema$.tw.
14 (spirochaeta adj5 pallid$).tw.
15 pallidum.tw.
16 exp Syphilis/
17 syphili$.tw.
18 lues.tw.
19 chancre.tw.
20 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19
21 11 and 20
Embase search strategy (Embase.com platform)
#1. 'syphilis rapid test'/exp
#2. 'point of care testing'/exp
#3. 'point of care':ab,ti
#4. (bedside NEAR/5 test*):ab,ti
#5. poc:ab,ti
#6. poct:ab,ti
#7. (rapid NEAR/5 test*):ab,ti
#8. (self NEAR/5 test*):ab,ti
#9. (self NEAR/5 collect*):ab,ti
#10. (self NEAR/5 swab*):ab,ti
#11. 'rapid test'/exp
#12. (syphilis NEAR/5 rapid NEAR/5 test):ab,ti
#13. #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12
#14. 'treponema pallidum'/exp
#15. 'treponematosis'/exp
#16. treponema*:ab,ti
#17. (spirochaeta NEAR/5 pallid*):ab,ti
#18. pallidum:ab,ti
#19. 'syphilis'/exp
#20. syphili*:ab,ti
#21. lues:ab,ti
#22. chancre:ab,ti
#23. #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22
#24. #13 AND #23
#25. #24 AND [embase]/lim
LILACS Biblioteca Virtual en Salud (BVS), interfaz iAHx
(mh:(Treponema pallidum)) OR (mh:(syphilis)) OR (ab:(syphilis)) OR (ti:(syphilis)) AND (ab:(point of care)) OR (ti:(point of care)) OR (ab:(test*)) OR (ti:(test*)) AND (instance:"regional") AND ( db:("LILACS"))
DARE Centre for Reviews and Dissemination ‐ University of York Platform
((test OR point of care) ) AND ((syphilis OR Treponema pallidum))
Web of Science
(TS=("point of care") OR TS=(test*)) AND TS=(syphilis) AND TI=(trial)
WHO International Clinical Trials Registry Platform
point of care AND syphilis
Health Services Research Projects in Progress (HSRProj)
("point of care") AND (syphilis)
Sexually Transmitted Infection (STI) Cochrane Review Group´s Specialized Register (CRS)
# 1 (point of care:AB) AND (INREGISTER)
# 2 (point of care:TI) AND (INREGISTER)
# 3 (syphilis:AB) AND (INREGISTER)
# 4 (syphilis:TI) AND (INREGISTER)
# 5 ((1 or 2) and (3 or 4))
Appendix 2. Quality Assessment Checklist (QUADAS‐2)
| DOMAIN 1: PATIENT SELECTION | |
| A. Risk of bias | The included study describes appropriately the methods of patient selection. |
| Was a consecutive or random sample of patients enrolled? | Yes: The study reported a consecutive or a random sample of patients enrolled. Unclear: The method of sampling is not reported or is unclear. No: The study did not implement a consecutive or a random sample method for patients enrolled. |
| Was a case‐control design avoided? | Yes: The study avoid implementation of 2 separate selection processes to sample patients with the target condition and patients without the target condition. Unclear: The method of selection processes is not reported or is unclear. No: The study did not avoid implementation of 2 separate selection processes to sample patients with the target condition and patients without the target condition. |
| Did the study avoid inappropriate exclusions? | Yes: The study included all outpatients (in primary or secondary care) without previous test results, regardless of their symptomatic status or baseline risk (low‐ and high‐risk populations). Unclear: Prior test history of patients in the study was not reported. No: The study included only patients who had received a previous test or were symptomatic or were a high‐risk population. |
| Judgment: Could the selection of patients have introduced bias? | Risk of bias: LOW/HIGH/UNCLEAR |
| B. Concerns regarding applicability | The included study describes appropriately baseline information on participants: presentation at recruitment, prior testing, intended use of index test, and setting. |
| Judgment: Is there concern that the included patients do not match the review question in terms of severity of the target condition, demographic features, presence of differential diagnosis or comorbidity, setting of the study, and previous testing protocols? | Concern: LOW/HIGH/UNCLEAR |
| DOMAIN 2: INDEX TEST | |
| A. Risk of bias | The included study describes appropriately the index test and how it was conducted and interpreted. |
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes: The index tests were interpreted in a blind manner without knowledge of the results of the reference standard, or the index test was always performed and interpreted before results of the reference standard were known. Unclear: It is not reported whether the index test was conducted without knowledge of the results of the index test, or whether the index test was completed before the reference standard was known. No: The results of the reference standard were known to the reader of the index test. |
| Judgment: Could the conduct or interpretation of the index test have introduced bias? | Risk of bias: LOW/HIGH/UNCLEAR |
| B. Concerns regarding applicability | Variations in test technology, execution, or interpretation may affect estimates of its diagnostic accuracy. |
| Judgment: Is there concern that the index test, its conduct, or its interpretation differs from the review question? | Concern: LOW/HIGH/UNCLEAR |
| DOMAIN 3: REFERENCE STANDARD | |
| A. Risk of bias | The included study describes appropriately the reference standard and how it was conducted and interpreted. |
| Is the reference standard likely to correctly classify the target condition? | Yes: The reference standard was conducted and interpreted by trained operatives. Unclear: It is not clear whether those individuals who interpreted or conducted the reference standard were trained. No: The reference standard was not conducted or interpreted by trained operatives. |
| Were the reference standard results interpreted without knowledge of the results of the index test? | Yes: The index tests were interpreted in a blind manner without knowledge of the results of the index test, or the reference standard was always performed and interpreted before the index test results were known. Unclear: it is not reported whether the reference standard was conducted without knowledge of the results of the index test, or whether the reference standard was completed before the index test results were known. No: The results of the index test were known to the reader of the reference standard. |
| Judgment: Could the reference standard, its conduct, or its interpretation have introduced bias? | Risk of bias: LOW/HIGH/UNCLEAR |
| B. Concerns regarding applicability | The reference standard may be free of bias, but the target condition that it defines may differ from the target condition specified in the review question. |
| Judgment: Is there concern that the target condition as defined by the reference standard does not match the review question? | Concern: LOW/HIGH/UNCLEAR |
| DOMAIN 4: FLOW AND TIMING | |
| A. Risk of bias | |
| Was there an appropriate interval between index test and reference standard? | Yes: The index test and reference standard were collected on the same patients at the same time. Unclear: It is unclear if the index test and the reference standard were collected on the same patients at the same time. No: The index test and the reference standard were not collected on the same patients at the same time. |
| Did all patients receive the reference standard? | Yes: The total of the study group received confirmation of the diagnosis by the reference standard. Unclear: In case insufficient information is available to make a judgment. No: The total of the study group did not receive confirmation of the diagnosis by the reference standard. |
| Did patients receive the same reference standard irrespective of the index test results ? | Yes: The total of the study group received the same reference standard irrespective of the index test results. Unclear: In case insufficient information is available to make a judgment. No: Participants received the reference standard according to the index test results. |
| Were all patients included in the analysis? | Yes: If it is clear what happened to all patients who entered the study, for example, if a flow diagram of study participants is reported to explain any withdrawals or exclusions, or if the numbers recruited match those in the analysis. Unclear: If it is unclear how many patients entered and hence whether there were any withdrawals. No: If it appears that some of the patients who entered the study did not complete the study, i.e. did not receive both the index test and the reference standard, and if these patients were not accounted for. |
| Could the patient flow have introduced bias? | Risk of bias: LOW/HIGH/UNCLEAR |
