Research Article

Evaluation of a U.S. Public Health Laboratory Service for the Molecular Detection of Drug Resistant Tuberculosis

Table 1

Survey responses from PHL officials who utilized CDC’s MDDR.

VariableNumberPercent

Where information first obtained on CDC’s MDDR
 CDC website1/353
 “Dear Colleague” letter6/3518
 Conference call with CDC3/359
 Professional meeting9/3526
 Regional Training and Medical Consultation Center (RTMCC)0/350
 TB control program7/3520
 Another public health laboratory1/353
 CDC TB laboratory consultant8/3523
Initiates requests for using CDC’s MDDR
 Health care provider12/3534
 TB control program25/3571
 Laboratory17/3549
 Laboratory only after consultation with program staff10/3529
 Other2/356
Satisfaction with turnaround time for receiving results from CDC’s MDDR
 Very satisfied26/3574
 Satisfied8/3523
 Neither satisfied nor dissatisfied1/353
 Dissatisfied0/350
 Very dissatisfied0/350
Usual time frame to report molecular results from CDC’s MDDR to health care providers
 Reported within one business day21/3560
 Reported within two business days5/3514
 Reporting time varies depending on circumstances 1/353
 Results are reported to health care provider by TB control program8/3523
 Not applicable. Health care provider receives separate report from CDC’s MDDR0/350
Withhold reporting molecular results from CDC’s MDDR to health care providers until phenotypic DST is completed by CDC
 Yes0/350
 Sometimes0/350
 No, results reported as soon as possible30/3586
 Not applicable. Results are reported to health care provider by TB control program 5/3514
 Not applicable. Health care provider receives separate report from CDC’s MDDR0/350
Withhold reporting molecular results from CDC’s MDDR to health care providers until phenotypic DST is completed by your laboratory
 Yes0/350
 Sometimes0/350
 No, molecular results reported as soon as possible29/3583
 Not applicable. Results are reported to health care provider by TB control program6/3517
 Not applicable. Health care provider receives separate report from CDC’s MDDR0/350
Method (s) for reporting results from CDC’s MDDR to health care providers
 Verbally9/3526
 Copy of CDC report is provided31/3589
 CDC results transcribed into LIMS for reporting1/353
 Not applicable. Results are not reported by our laboratory3/359
Comparison of molecular results from CDC’s MDDR with own phenotypic DST for first-line drugs
 Yes, we always compare molecular results from CDC with our phenotypic DST for first-line drugs 30/3586
 Sometimes we compare molecular results from CDC with our own phenotypic DST for first-line drugs2/356
 No, we report molecular results from CDC without comparing to our own phenotypic DST first-line drugs 1/353
 Not applicable. We do not perform phenotypic DST for first-line drugs 2/356
Reasons for comparing molecular results from CDC’s MDDR with own phenotypic DST for first-line drugs
 Results compared for quality assurance27/3284
 Results compared to increase understanding of molecular testing23/3272
 Results are compared to find discordance29/3291
 Results are compared to prepare for consultation with health care provider or TB control program20/3263
Found discordance when molecular results from CDC’s MDDR compared to own phenotypic DST for first-line drugs
 Yes, we found potentially discordant results16/3250
 No, we have not found any potentially discordant results16/3250
Actions taken when discordance found between molecular results from CDC’s MDDR and own phenotypic DST for first-line drugs
 No action taken2/1613
 Contacted CDC to discuss results9/1656
 Retested isolate in our laboratory10/1663
 Withheld sending CDC results to health care provider or TB control 0/160
 Notified TB control program of potential discordance13/1681
 Initiated a corrective plan in our laboratory1/166
 Referred isolate from patient to another laboratory other than CDC for molecular testing0/160
 Action taken dependent on which drug has discordant test results2/1613
Comparison of molecular results from CDC’s MDDR with own phenotypic DST for second-line drugs
 Yes, we always compare molecular results from CDC with our phenotypic DST for second-line drugs13/3537
 Sometimes we compare molecular results from CDC with our own phenotypic DST for second-line drugs2/356
 No, we do not perform second-line DST 20/3557
 No, we perform second-line DST but do not compare with molecular results from CDC 0/350
Impact on your local phenotypic DST when first available results are molecular results from CDC’s MDDR
 Results have no impact on local phenotypic DST24/3569
 Local results are discarded 0/350
 If resistance is indicated by molecular results, isolate is referred to another laboratory other than CDC’s MDDR for additional testing3/359
 Other8/3523
Observed discordance between the molecular results and the phenotypic DST on the final report from CDC’s MDDR
 Yes, we have observed discordance12/3534
 No, we have not observed discordance20/3557
 No, we do not examine CDC’s MDDR results for discordance3/359
Actions taken when discordance observed between molecular results and phenotypic results reported by CDC’s MDDR
 No additional actions taken3/1225
 Contacted CDC to discuss results5/1242
 Retested isolate in our laboratory6/1250
 Withheld sending CDC results to health care provider or TB control0/120
 Contacted TB control program to notify them of potential discordance10/1283
 Referred an isolate from the patient to another laboratory other than CDC for molecular testing1/358
 Referred an isolate from the patient to another laboratory other than CDC for phenotypic DST1/358
 Action taken dependent on which drug has discordant results2/3517
Difficulty interpreting molecular results from CDC’s MDDR
 Results were very difficult to interpret0/350
 Results somewhat difficult to interpret9/3526
 Results were not difficult to interpret17/3549
 Results were very easy to interpret9/3526
Comfort discussing interpretation of molecular results from CDC’s MDDR with health care providers or TB control
 Very comfortable when discussing the results23/3566
 Had some difficulty discussing the results5/3514
 In most instances, not contacted for help interpreting the results7/3520
Sought help interpreting results from CDC’s MDDR
 Contacted CDC for help interpreting results16/3546
 Visited CDC website for more information on molecular testing5/3514
 Consulted with clinician2/356
 Did my own research to find information on molecular testing7/3520
 Contacted local TB program5/3514
 Contacted Regional Training and Medical Consultation Center (RTMCC)1/353
 I did not seek help 14/3540

PHL = Public Health Laboratory.
CDC = Centers for Disease Control and Prevention.
MDDR = molecular detection of drug resistance.
DST = drug susceptibility testing.
LIMS = Laboratory Information Management System.