THIS IS AN OFFICIAL NH DHHS HEALTH ALERT

Transcription

1 THIS IS AN OFFICIAL NH DHHS HEALTH ALERT Dstrbuted by the NH Health Alert Network August 26, EDT (2:30 PM EDT) NH-HAN Recommendatons for Accurate Dagnoss of HIV Infecton Key Ponts 1. HIV screenng and testng technology contnues to mprove, whch may present challenges wth nterpretaton and reportng of results. DPHS has become aware of several recent cases n whch clncans nterpreted testng and nformed patents ncorrectly. 2. Healthcare provders and laboratores should revew and follow the Centers for Dsease Control and Preventon s (CDC) Recommended Laboratory HIV Testng Algorthm for Serum or Plasma Specmens and Reportng Results from the HIV Dagnostc Testng Algorthm to Persons Orderng HIV tests and Publc Health Authortes. 3. All new HIV dagnoses (ncludng postve prelmnary results) must be reported to the NH Dvson of Publc Health Servces at Ext or (603) wthn 72 hours of dagnoss or suspcon of dagnoss. Background Informaton CDC estmates that there are 1.2 mllon people n the Unted States lvng wth HIV, ncludng 156,300 people who do not know they are nfected. Each year, nearly 45,000 people are dagnosed wth HIV and 30% of new HIV nfectons are transmtted by people who are lvng wth undagnosed HIV. HIV testng s recommended for: All adults and adolescents from ages 13 to 64 at least once n ther lfetme All women when a pregnancy s confrmed Annually for persons who have sex wthout a condom or share drug equpment Annually for sexually actve men who have sex wth men HIV screenng and testng technology contnues to mprove, whch may present challenges wth nterpretaton and reportng of results. Current HIV assays whch are approved by the Food and Drug Admnstraton (FDA) allow detecton of HIV sooner after nfecton than prevous assays whch s useful because HIV transmsson from persons wth acute nfecton s much more lkely than from persons wth establshed nfecton; and startng antretrovral treatment (ART) early n the course of HIV nfecton has clncal benefts and can reduce the rsk of transmsson. DPHS has become aware of several recent cases n whch clncans nterpreted testng and nformed patents ncorrectly. In one such example, a patent reported a hstory of sharng njecton drug equpment and was tested for HIV. The clncan receved a laboratory report that read Repeatedly Reactve for the HIV 1/2 Ag/Ab and Negatve by HIV 1/2 Ab Dfferentaton. Subsequently, the

2 clncan receved a report that HIV-1 was not detected by the Nuclec Acd Amplfcaton Test. However, the provder nformed the patent that he had HIV based on the frst test. There are now three types of HIV dagnostc tests: HIV 1/2 antgen/antbody combnaton (often referred to as the 4 th Generaton HIV test), HIV1/2 dfferentaton and HIV-1 NAT, as ndcated n the testng algorthm. Test HIV-1/2 antgen/antbody combnaton (often referred to as the 4 th Generaton test) HIV-1/HIV-2 antbody dfferentaton HIV-1 Nuclec Acd Amplfcaton Test Purpose of the Test These tests detect acute and chronc HIV nfecton. It can take 2 to 6 weeks after ntal nfecton to dentfy HIV nfecton usng these tests. Ths s a screenng test and postve specmens must be confrmed by other tests. No further testng s requred for specmens that are nonreactve on the ntal. HIV-1/HIV-2 dfferentaton assays are used followng a postve HIV-1/2 antgen/antbody combnaton n order to dstngush between HIV-1 and HIV-2. These tests dentfy nfecton wth HIV-1 wthn 7 to 28 days of the ntal HIV nfecton. Recommendatons Implement CDC recommendatons for HIV testng of adults, adolescents and pregnant women. Revew and follow the Centers for Dsease Control s (CDC) Recommended Laboratory HIV Testng Algorthm for Serum or Plasma Specmens (Attachment A) and Reportng Results from the HIV Dagnostc Testng Algorthm to Persons Orderng HIV tests and Publc Health Authortes (Attachment B). Report all postve HIV dagnostc testng results (ncludng postve prelmnary results) to the NH Dvson of Publc Health Servces at Ext or (603) wthn 72 hours of dagnoss or suspcon of dagnoss. 2

3 For Addtonal Informaton For any questons regardng the contents of ths message, please contact NH DHHS, DPHS, Bureau of Infectous Dsease Control at (after hours ). To change your contact nformaton n the NH Health Alert Network, contact Thom Flynn at or emal thomas.flynn@dhhs.nh.gov. Status: Actual Message Type: Alert Severty: Moderate Senstvty: Not Senstve Message Identfer: NH-HAN Recommendatons for Accurate Dagnoss of HIV Infecton Delvery Tme: 5 hours Acknowledgement: No Dstrbuton Method: Emal, Fax Dstrbuted to: Physcans, Physcan Assstants, Practce Managers, Infecton Control Practtoners, Infectous Dsease Specalsts, Communty Health Centers, Hosptal CEOs, Hosptal Emergency Departments, Nurses, Long-Term Care Facltes, NHHA, Laboratory Response Network, Manchester Health Department, Nashua Health Department, Publc Health Network, DHHS Outbreak Team, DPHS Investgaton Team, DPHS Management Team, Northeast State Epdemologsts From: Elzabeth A. Talbot, MD Deputy State Epdemologst Orgnatng Agency: NH Department of Health and Human Servces, Dvson of Publc Health Servces Attachments: Attachment A - Recommended Laboratory HIV Testng Algorthm Attachment B - Reportng results from the HIV dagnostc testng algorthm Follow us on 3

4 Attachment A Recommended Laboratory HIV Testng Algorthm for Serum or Plasma Specmens 1. Laboratores should conduct ntal testng for HIV wth an FDA-approved antgen/antbody combnaton * that detects HIV-1 and HIV-2 antbodes and HIV-1 p24 antgen to screen for establshed nfecton wth HIV-1 or HIV-2 and for acute HIV-1 nfecton. No further testng s requred for specmens that are nonreactve on the ntal. 2. Specmens wth a reactve antgen/antbody combnaton result (or repeatedly reactve, f repeat testng s recommended by the manufacturer or requred by regulatory authortes) should be tested wth an FDA-approved antbody that dfferentates HIV-1 antbodes from HIV-2 antbodes. Reactve results on the ntal antgen/antbody combnaton and the HIV-1/HIV-2 antbody dfferentaton should be nterpreted as postve for HIV-1 antbodes, HIV-2 antbodes, or HIV antbodes, undfferentated. 3. Specmens that are reactve on the ntal antgen/antbody combnaton and nonreactve or ndetermnate on the HIV-1/HIV-2 antbody dfferentaton should be tested wth an FDA-approved HIV- 1 nuclec acd test (NAT). A reactve HIV-1 NAT result and nonreactve HIV-1/HIV-2 antbody dfferentaton result ndcates laboratory evdence for acute HIV-1 nfecton. A reactve HIV-1 NAT result and ndetermnate HIV-1/HIV-2 antbody dfferentaton result ndcates the presence of HIV-1 nfecton confrmed by HIV-1 NAT. A negatve HIV-1 NAT result and nonreactve or ndetermnate HIV-1/HIV-2 antbody dfferentaton result ndcates a false-postve result on the ntal. 4. Laboratores should use ths same testng algorthm, begnnng wth an antgen/antbody combnaton, wth serum or plasma specmens submtted for testng after a reactve (prelmnary postve) results from any rapd HIV test. 5. *Excepton: As of Aprl, 2014, data are nsuffcent to recommend use of the FDA-approved sngle-use rapd-hiv-1/hiv-2 antgen/antbody combnaton as the ntal assay n the algorthm. A reactve HIV-1 NAT result and nonreactve HIV-1/HIV-2 antbody dfferentaton result ndcates laboratory evdence for acute HIV-1 nfecton. 4

5 Attachment B Reportng results from the HIV dagnostc testng algorthm to persons orderng HIV tests and publc health authortes 1 Test performed Test results Fnal nterpretaton for provder report 1. HIV-1/2 Ag/Ab combnaton 1. Nonreactve Negatve for HIV-1 antgen and HIV-1/HIV-2 antbodes. No laboratory evdence of HIV nfecton. If acute HIV nfecton s suspected, 1. HIV-1/2 Ag/Ab combnaton Postve d for t HIV-1 t f antbodes. HIV 1 RNA Laboratory 2. HIV-1 reactve and HIV-2 evdence consstent wth establshed HIV-1 t nfecton s present 1. HIV-1/2 Ag/Ab combo 1. HIV-1/2 Ag/Ab combnaton 3. HIV-1 RNA assay 1. HIV-1/2 Ag/Ab combnaton 3 HIV 1 RNA 1. HIV-1/2 Ag/Ab combnaton 3 HIV 1 RNA 1. HIV-1/2 Ag/Ab combnaton 1. HIV-1/2 Ag/Ab combnaton 2. HIV-1 nonreactve and HIV-2 t 2. Nonreactve or ndetermnate 3. RNA not detected 2. Nonreactve 3. RNA detected 2. Indetermnate 3. RNA detected 2. HIV-1 and HIV-2 reactve Abbrevatons: Ag/Ab, antgen/antbody; RNA, rbonuclec acd. 2. Nonreactve or ndetermnate Postve for HIV-2 antbodes. Laboratory evdence of HIV-2 nfecton s present. HIV antbodes were not confrmed and HIV-1 RNA was not detected. No laboratory evdence of HIV-1 nfecton. Follow-up testng for HIV-2 should be performed f clncally Postve d t d for HIV-1. Laboratory evdence consstent wth acute HIV-1 nfecton s present. Postve for HIV-1 antbodes. Laboratory evdence of HIV-1 nfecton confrmed by HIV-1 RNA. Postve for HIV antbodes. Laboratory evdence of HIV nfecton s present. HIV antbodes could not be dfferentated as HIV- 1 or HIV-2. Addtonal testng for HIV-1 RNA or HIV-2 RNA should be performed f HIV-1 l ll antbodes d d were not confrmed and HIV-1 RNA testng was not performed. Testng of ths specmen s ncomplete. Follow-up testng for HIV antbodes and HIV-1 RNA s d d bl Test results to be reported to publc h lth th t Reportng ths test result s not requred. Reportng ths test result s not requred. Report test results 1, 2, and 3. Report test results 1, 2, and 3. Adapted from Interm Gudelnes for Laboratores on the Use of a New Dagnostc Testng Algorthm for Human Immunodefcency Vrus (HIV) Infecton. New York State Department of Health ( 5