2018 HIV and HCV Diagnostic Testing Survey

Transcription

1 2018 HIV and HCV Diagnostic Testing Survey This survey is designed to capture the 2017 HIV and HCV testing practices in state and local public health laboratories (PHL). The results of the survey will help APHL understand the current capacity and capabilities of HIV and HCV testing in the public health laboratory, and to create resources and tools to support our members. Questions 1 through 14 refer to your HIV laboratory diagnostic testing algorithm from January 1, December 31, Does your laboratory receive samples for? Please check all that apply Screening serum/plasma Screening oral fluid Screening dried blood spot (DBS) Confirmation of preliminary positive rapid tests Referral testing from out of state submitters Other, please specify Our laboratory no longer receives samples for HIV Testing, if testing was discontinued at any point after our last survey (December 2014) please provide narrative for when the testing was discontinued and reasons (i.e. lab decision (cost/staffing), program decision, etc.) (Proceed to Question 19) 2. How many full-time equivalents does your laboratory routinely assign for HIV testing? Please enter number. 3. Which HIV immunoassay did your laboratory use for initial laboratory screening of serum/plasma specimens? Please select only one. Architect HIV Ag/Ab Combo (Abbott) ADVIA HIV Ag/AB Combo (Siemens) ADVIA Centaur HIV 1/O/2 Enhanced (Siemens) BioPlex 2200 HIV Ag-Ab (Bio-Rad) Determine HIV-1/2 Ag/Ab Combo (Alere) Elecsys HIV Combi PT (Roche) GS HIV-1/HIV-2 Plus O EIA (Bio-Rad) GS HIV Combo Ag/Ab EIA (Bio-Rad) HIV-1 Microelisa (Avioq) VITROS Anti-HIV 1+2 Immunoassay (Ortho) Our lab switched assays in 2017 (Please proceed to question 3a) Other- please specify: Not applicable 3a. Please specify the two assays used in 2017: Previous HIV Immunoassay: Current HIV Immunoassay: Approximate Date of Switch: 1

2 4. After a reactive laboratory screening immunoassay, what supplemental antibody test did your laboratory perform on serum/plasma specimens? Please select only one. Geenius HIV-1/2 Supplemental Assay (Bio-Rad) HIV-1 Western blot (Any manufacturer) HIV-1 IFA (Any manufacturer) Laboratory refers supplemental testing to another laboratory. (Please proceed to Q10) Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad) Our lab switched assays in 2017 (Please proceed to question 4a) Other- please specify: Not applicable 4a. Please specify the two assays used in 2017: Previous supplemental antibody test: Current supplemental antibody test: Approximate date of Switch: 5. If the laboratory screening immunoassay is reactive and the supplemental antibody test is nonreactive what is your laboratory s next step? Please check all that apply. Report all results with no recommendation for additional testing or follow-up Report result/interpretation as inconclusive or indeterminate and request additional specimen Report result/interpretation as inconclusive or indeterminate and perform additional testing (Please proceed to question 5a) Report result/interpretation as inconclusive or indeterminate and refer for additional testing (Please proceed to question 5a) Perform additional testing before reporting (Please proceed to question 5a) Refer for HIV-1 NAT before reporting Refer for additional testing before reporting, please specify testing requested: Other- please specify: 5a. What additional tests does your laboratory conduct or refer from Question 5? Please check all that apply and if more than one is chosen, order your responses according to the testing steps in your protocol. Geenius HIV-1/2 Supplemental Assay (Bio-Rad) HIV-1 IFA HIV-2 EIA HIV-1 NAT HIV-2 NAT HIV-1 Western blot HIV-2 Western blot Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad) Other-please specify: 2

3 6. If the laboratory screening immunoassay is reactive and the supplemental antibody test result is HIV-2 antibody positive (with or without cross-reactivity), what does your laboratory do? Please check all that apply. Report all results with no recommendation for additional testing or follow-up Report result/interpretation as HIV-2 positive and request additional specimen Report result/interpretation as HIV-2 positive and perform additional testing (Please proceed to question 6a) Report result/interpretation as HIV-2 positive and refer for additional testing (Please proceed to question 6a) Perform additional testing before reporting (Please proceed to question 6a) Refer for HIV-2 NAT before reporting, please specify laboratory: Refer for additional testing before reporting, please specify testing requested: Other- please specify: Not Applicable (This is not a result from the supplemental antibody test our laboratory uses) 6a. What additional tests does your laboratory conduct or refer in the previous scenario? Please check all that apply and if more than one is chosen, order your responses according to the testing steps in your protocol. HIV-2 EIA HIV-2 NAT HIV-2 Western blot Other-please specify: 7. If the laboratory screening immunoassay is reactive and the supplemental antibody test is HIV-1 indeterminate what is your laboratory s next step? Please check all that apply. Report all results with no recommendation for additional testing or follow-up Report result/interpretation as inconclusive or indeterminate and request additional specimen Report result/interpretation as inconclusive or indeterminate and perform additional testing (Please proceed to question 7a) Report result/interpretation as inconclusive or indeterminate and refer for additional testing (Please proceed to question 7a) Perform additional testing before reporting (Please proceed to question 7a) Refer for HIV-1 NAT before reporting Refer for additional testing before reporting, please specify: Other- please specify: Not Applicable (This is not a result from the supplemental antibody test our laboratory uses) 7a. What additional tests does your laboratory conduct or refer in the previous scenario? Please check all that apply and if more than one is chosen, order your responses according to the testing steps in your protocol. 3

4 Geenius HIV-1/2 Supplemental Assay (Bio-Rad) HIV-1 IFA HIV-2 EIA HIV-1 NAT HIV-2 NAT HIV-1 Western blot HIV-2 Western blot Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad) Other-please specify: 8. If the laboratory screening immunoassay is reactive and the supplemental antibody test is HIV indeterminate what is your laboratory s next step? Please check all that apply. Report all results with no recommendation for additional testing or follow-up Report result/interpretation as inconclusive or indeterminate and request additional specimen Report result/interpretation as inconclusive or indeterminate and perform additional testing (Please proceed to question 8a) Report result/interpretation as inconclusive or indeterminate and refer for additional testing (Please proceed to question 8a) Perform additional testing before reporting (Please proceed to question 8a) Refer for HIV-1 NAT before reporting Refer for HIV-2 NAT before reporting Refer for other testing before reporting, please specify: Other- please specify: Not Applicable (This is not a result from the supplemental antibody test our laboratory uses) 8a. What additional tests does your laboratory conduct or refer in the previous scenario? Please check all that apply and if more than one is chosen, order your responses according to the testing steps in your protocol. Geenius HIV-1/2 Supplemental Assay (Bio-Rad) HIV-1 IFA HIV-2 EIA HIV-1 NAT HIV-2 NAT HIV-1 Western blot HIV-2 Western blot Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad) Other-please specify: 9. If the laboratory screening immunoassay is reactive and the supplemental antibody test is HIV-2 indeterminate (after repeat per Geenius package insert) what is your laboratory s next step? Please check all that apply. Report all results with no recommendation for additional testing or follow-up Report result/interpretation as inconclusive or indeterminate and request additional specimen 4

5 Report result/interpretation as inconclusive or indeterminate and perform additional testing (Please proceed to question 9a) Report result/interpretation as inconclusive or indeterminate and refer for additional testing (Please proceed to question 9a) Perform additional testing before reporting (Please proceed to question 9a) Refer for HIV-1 NAT before reporting Refer for HIV-2 NAT before reporting Refer for additional testing before reporting, please specify: Other- please specify: Not Applicable (This is not a result from the supplemental antibody test our laboratory uses) 9a. What additional tests does your laboratory conduct? Please check all that apply and if more than one is chosen, order your responses according to the testing steps in your protocol. Geenius HIV-1/2 Supplemental Assay (Bio-Rad) HIV-1 IFA HIV-2 EIA HIV-1 NAT HIV-2 NAT HIV-1 Western blot HIV-2 Western blot Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad) Other-please specify: 10. Does your laboratory perform HIV-1 Nucleic Acid Testing (NAT) for serum/plasma samples? Yes, we perform testing in-house (Please proceed to question 10a, 10b) No, we refer out specimens for HIV-1 NAT (Please proceed to question 10c) No, we don t provide HIV-1 NAT testing. Other, please describe 10a. What specimen types does your laboratory accept for HIV-1 NAT? Please check all that apply. Serum Plasma Other-please specify: 10b. For what purpose(s) is an HIV-1 NAT performed or referred and which assay is used for each purpose? Please select the assay that is used for each purpose by selecting the box (or placing an X in the box). If you don t perform NAT for that purpose, please select N/A. 5

6 N/ A APTIMA HIV-1 RNA Qualitative Assay (Hologic) COBAS Ampli- Prep/COBAS TaqMan HIV-1 Test (Roche) Cobas HIV-1 (Roch e) HIV-1 RNA Quantitative Assay, please specify assay Laboratory Developed Nucleic Acid Test Assay, Qualitative Laboratory Developed Nucleic Acid Test Assay, Quantitative RealTime HIV-1 Amplifica tion Kit (Abbott) Other HIV-1 NAT Method Diagnosis/ detect acute infection (Final Step in Algorithm) Supplemental test for HIV-1 p24 Ag positive samples (Following BioPlex or Alere Determine HIV-1 Ag only results) Clinical management / Viral Load Infant Diagnosis Please specify any other purpose that HIV-1 NAT is performed or referred. 10c. Where does your laboratory refer HIV-1 NAT? Refer to APHL NAT Referral laboratory (Florida Bureau of Laboratories or Wadsworth Center) Refer to another public health laboratory Refer to commercial laboratory (e.g. Quest, Lab Corp) Refer to clinical or hospital laboratory in your jurisdiction Other please specify Questions 11 through 14 refer to your HIV laboratory diagnostic testing algorithm from January 1, December 31,

7 11. In 2017, what was your average turnaround time (days) from sample receipt to reporting results for specimens that were: Negative on your screening assay: HIV Positive and did not require HIV NAT: HIV-1 Positive and required HIV-1 NAT: 12. In 2017, how many total specimens did your laboratory receive for HIV laboratory diagnostic testing (Do not include proficiency testing specimens or specimens submitted solely for patient management e.g. viral load)? 13. Of the total specimens submitted, how many of each of the following specimen types did your laboratory receive for HIV diagnostic testing in 2017? Please enter 0 for specimen types not received for testing. Plasma Serum Serum/Plasma (unable to distinguish) Oral fluid Dried blood spot Other Unknown Whole blood 14. Of all serum/plasma specimens received in 2017, how many of the following HIV results did your laboratory report? Note: you may not report all of these categories depending on how you report. Select the ones you report and then report an integer for the number tested. The total number of results in this question should equal the sum of specimens listed for Serum, Plasma or Serum/Plasma (unable to distinguish). Negative (e.g. screening test nonreactive or screening test reactive, supplemental testing (Antibody and NAT) does not confirm) Acute HIV-1 Positive (e.g. IA+ and supplemental Ab -/indeterminate and HIV-1 NAT detected) HIV-1 Positive (e.g. IA+ and supplemental Ab testing confirms HIV-1) HIV-2 Positive (e.g. IA+ and supplemental Ab testing confirms HIV-2) HIV Positive (eg. IA+ and supplemental Ab testing untypeable or undifferentiated) HIV-1 Negative, HIV-2 Inconclusive (eg.ia+ and supplemental Ab testing was either repeatedly HIV-2 indeterminate or HIV indeterminate and not detected by HIV-1 NAT) Inconclusive (e.g. IA+ and negative or indeterminate on supplemental Ab test and HIV-1 NAT was invalid or not performed) Not tested (e.g. sample rejected) 7

8 Questions 15 and 16 refer to confirmation of preliminary positive rapid tests conducted in 2017 (January 1, December 31, 2017) 15. Does your laboratory receive specimens for confirmation of preliminary positive rapid tests performed outside your laboratory (in a CLIA-waived setting)? Yes (Please proceed to 15a) No (Please proceed to question 17 or 19 depending on response to Q1) Not sure (Please proceed to question 17 or 19 depending on response to Q1) 15a. For specimens that were preliminary positive on a rapid test what specimen type(s) did your laboratory receive for follow-up HIV testing? Please check all that apply. Sample Type Used for Rapid Testing Sample Type Received for Confirmation Blood Oral Fluid Unknown Plasma Serum Plasma/Serum (undistinguishable) Oral Fluid Dried Blood Spot Whole Blood Other N/A 16. How many whole blood/serum/plasma specimens were received following a preliminary positive rapid test performed outside of your laboratory (CLIA waived setting)? Please enter a number 16a. How many whole blood/serum/plasma specimens received for rapid test confirmation were reported as negative following confirmatory testing by your laboratory? Please enter a number 8

9 Questions 17 and 18 concern your laboratory s testing practices for ORAL FLUID specimens ONLY. 17. What test did your laboratory use for screening of oral fluid specimens as of December 31, 2017? Avioq HIV-1 Microelisa Bio-Rad HIV-1/HIV-2 Plus O EIA Chembio DPP HIV 1/2 Assay OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Other- please specify: Not applicable, our PHL did not perform testing on oral fluid during 2017 Discontinued or changed testing between 1/1/2017 and 12/31/17 (Please proceed to question 17a) 17a. Please provide an explanation (including approximate dates) of any discontinuation or change in Oral Fluid Testing. 18. How did/does your laboratory plan to respond to the discontinuation of the OraSure Western Blot? Validate another HIV assay for Oral Fluid confirmation, please specify which assay you have or will validate. Refer to another laboratory Discontinue oral fluid testing Other please specify Not applicable, our PHL did not perform testing on oral fluid during 2017 Questions 19 through 22 concern your laboratory s potential changes in testing practices 19. Does your laboratory have any plans to add or change any HIV testing services before December 31, 2018? Yes (Please proceed to question 19a) No Unsure 19a. Which of the following HIV diagnostic testing services is your laboratory considering adding or changing? Please check all that apply HIV Screening Assay (Please select at least one response per section) Add screening assay to be performed on site, specify new assay in comments 9

10 Replace existing screening assay with a new screening assay; specify old and new assays in comments Modify an existing screening assay; specify modification in comments Referring screening assay to another laboratory No changes planned for HIV Screening Assay HIV Supplemental Antibody Assay (Please select at least one response per section) Add supplemental assay to be performed on site, specify new assay in comments Replace existing supplemental assay with a new assay; specify old and new assays in comments Modify an existing supplemental antibody assay; specify modification in comments Referring supplemental antibody assay to another laboratory No changes planned for HIV Supplemental Antibody Assay HIV NAT (Please select at least one response per section) Add an HIV-1 NAT to be performed on site, specify new assay in comments Replace existing HIV-1 NAT performed on site with a new HIV-1 NAT, please specify old and new assays in comments Modify existing HIV-1 NAT; specify modification in comments. Referring HIV-1 NAT to another laboratory Add or change other HIV NAT, specify in comments No changes planned for HIV-1 NAT 20. New HIV testing technologies are on the horizon. If any of the following new technologies became FDA approved and/or included in the APHL/CDC HIV Laboratory Algorithm, which would your laboratory be interested in bringing on? (This is no way means that it will happen, but this information is useful to understand the needs) Please check all that apply. Rapid HIV-1/2 Ag/Ab Combination Immunoassay Alternative HIV-1/2 Ag/Ab Differentiating Combination Immunoassay Alternative supplemental HIV-1/2 antibody differentiation assay Rapid HIV NAT (HIV-1 and/or HIV-2) HIV-1 NAT with a dual claim (single assay that is FDA approved for diagnosis and viral load monitoring) HIV-2 NAT HIV-1 p24 Ag confirmatory assay Other, please specify 21. Does your laboratory have any plans to eliminate or decrease HIV testing services before December 31, 2018? Yes, go to 20a No Unsure 10

11 21a. What HIV testing services has or is your laboratory planning on eliminating or decreasing? Please provide a narrative of the potential changes and factors in those decisions. HIV Screening Assay(s), please describe planned change HIV Supplemental Antibody Assay(s), please describe planned change HIV-1 NAT, please describe planned change Other, please describe planned change 22. Did staff from your laboratory provide outreach, training or education regarding HIV diagnostic testing in 2017? Yes (please proceed to question 22a through 22c) No (please proceed to question 23) 22a.Of the outreach, training or education you provided, please identify the topics that you provided those on and the frequency with which you do that (Consider Phone calls, s, hotlines, meetings and any other format). Please select the 5 most common topics. Specimen Collection Specimen Handling/Requirements Implementing recommended diagnostic algorithm (e.g. appropriate tests, sequence) Rapid Tests (performance and selection of test kit) Rapid Tests (i.e., implementation and quality assurance) Guidance on Validating FDA Approved tests HIV Ag/Ab or HIV Ab Immunoassays (performance or platforms for screening tests) Supplemental HIV Ab differentiation tests (performance or platforms) HIV-1 NAT/RNA for Diagnosis (performance or platforms) HIV1-NAT/RNA for Viral Load/Monitoring Result Interpretation Algorithm Interpretation Result Reporting Cost of Tests Laboratory Developed Tests Other, please describe 22b. Please identify which entities your laboratory has provided outreach, training or education to regarding HIV diagnostic testing in Please select the three most common requesting entities. HIV Surveillance Program (Health Dept) HIV Prevention Program (Health Dept) HIV Patient Care (Health Dept) Clinicians/Providers Hospital Laboratories Commercial Laboratories Other Public Health Laboratories CLIA-Waived testing sites Other, please describe 11

12 22c. What modalities did you use for outreach, training, or education you provided on HIV Diagnostic testing? Please check all that apply Web-based seminar/meeting Web-based training In-person seminar/meeting In-person training On-line (self-guided) training Written guidance or information (e.g. newsletter, policy update, template procedures) Informal consultation via phone, , or other Other, please specify Hepatitis C Testing 23. Does your laboratory offer any testing services for the diagnosis or management of hepatitis C virus (HCV)? Yes (Please proceed to question 24) No (Please proceed to question 26) 24. What testing services does your laboratory offer? Please check all that apply o Anti-HCV Ab; laboratory based or rapid test (Please proceed to 24a) o HCV RNA (quantitative or qualitative) for diagnosis of HCV (confirmation of HCV antibody test (laboratory based or rapid test) (Please proceed to 24b) o HCV RNA (quantitative or qualitative) for patient management/viral load monitoring (Please proceed to 24c) o HCV genotyping (Please proceed to 24d) o HCV sequencing o Other, please specify: 24a. What Anti-HCV Ab assay does your laboratory offer for Hepatitis C screening? Abbott Architect Anti HCV OraSure OraQuick HCV Rapid Antibody Test Ortho VITROS Anti-HCV Roche Elecsys Anti-HCV Siemens ADVIA Centaur Anti-HCV Other Anti-HCV assay, please specify: 24b. What HCV RNA assay does your laboratory offer for Hepatitis C diagnosis? Please select all that apply. Parenthetical notation indicates intended use on FDA-approved Assay. Abbott RealTime HCV (Monitoring treatment) Roche cobas HCV (Diagnosis and Monitoring treatment) Roche COBAS Ampliprep/COBAS Taqman HCV Test, v2.0 (Diagnosis and Monitoring treatment) Roche COBAS Taqman HCV Test (Monitoring treatment) Hologic Hepatitis C Quant Dx Assay (Diagnosis and Monitoring treatment) Hologic APTIMA HCV RNA Qual (Diagnosis) Other HCV RT-PCR Qualitative, please specify: 12

13 Other HCV RT-PCR Quantitative, please specify: Other, please specify 24c. What HCV RNA assay does your laboratory offer for Hepatitis C management? Please select all that apply. Parenthetical notation indicates intended use on FDA-approved Assay. Abbott RealTime HCV (Monitoring treatment) Roche cobas HCV (Diagnosis and Monitoring treatment) Roche COBAS Ampliprep/COBAS Taqman HCV Test, v2.0 (Diagnosis and Monitoring treatment) Roche COBAS Taqman HCV Test (Monitoring treatment) Hologic Hepatitis C Quant Dx Assay (Diagnosis and Monitoring treatment) Hologic APTIMA HCV RNA Qual (Diagnosis) Other HCV RT-PCR Qualitative, please specify: Other HCV RT-PCR Quantitative, please specify: Other, please specify 24d. What HCV genotyping assay does your laboratory offer? Abbott Realtime HCV Genotype II Siemens VERSANT HCV Genotype 2.0 (LiPA) HCV Genotyping User developed Other HCV Genotyping, please specify: 25. What is the testing algorithm for HCV Diagnosis in your laboratory? o Laboratory performs HCV Ab screening only o Laboratory performs HCV Ab screening only and refers HCV Ab reactive specimens for HCV NAT to another laboratory o Laboratory performs HCV Ab screening only and recommends a second specimen is sent for HCV NAT to another laboratory to confirm HCV Ab reactivity o Laboratory performs HCV Ab screening and automatically reflexes all HCV Ab reactive specimens to an HCV NAT. o Laboratory performs HCV Ab screening and HCV Ab reactive specimens are only reflexed to HCV RNA testing in-house if they are less than the recommended s/co o Other, please specify 26. For which HIV and HCV topic areas would it be most useful to have additional tools/resources for your laboratory in the upcoming year? Please check all that apply. Implementing diagnostic algorithm-hiv Implementing diagnostic algorithm-hcv New/emerging diagnostic technologies-hiv New/emerging diagnostic technologies-hcv Integrated screening for multiple pathogens Educating clinical laboratories on diagnostic algorithms Validation of new assays Development of in house assays Incidence testing 13

14 Genotype testing LIMS/informatics infrastructure 3 rd party billing basics 3 rd party billing policy/regulation 3 rd party billing contracting with insurers Other please specify: None of the above Questions 27 through 28 refer to reimbursement methods utilized by public health laboratories for HIV diagnostic testing conducted in 2017 (January 1, December 31, 2017) 27. Is your laboratory currently seeking reimbursement from Medicaid, Medicare or other third-party payers for HIV diagnostic testing? Please check one. Yes, currently billing for HIV testing services (Please proceed to questions 27 a-d) No, but plan to implement billing within the next 12 months (Please proceed to question 28) No plans to implement billing in the next 12 months (Please proceed to questions 28) Don't offer HIV or HCV testing (Please proceed to question 28) Don t know (Please proceed to question 28) 27a. From which of the following payers does your health department currently seek reimbursement for HIV testing services? Please check all that apply. Medicaid Medicare Private insurance Other - please specify: Not Sure-please specify: 27b. By what mechanism does your laboratory seek reimbursement from Medicaid and/or other thirdparty payers for HIV testing services? Please check one. Health department bills insurers directly Health department bills providers Other - please specify: Not Sure-please specify: 27c. If your laboratory is receiving reimbursement from third-party payers for HIV testing services, where does that revenue go? Please check one. To the laboratory earmarked for HIV testing To the laboratory other To the health department HIV/AIDS program To the health department general or other fund To the state general fund 14

15 Other - please specify: Not Sure 28. Is your laboratory also seeking reimbursement for HCV testing? o Yes o No o Not Applicable (We do not perform HCV Testing) 15