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Celkový stav vyšetřování HIV protilátek v ČR dle registru SZÚ (NRL AIDS) k 31.12. 2002.

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Presentation on theme: "Celkový stav vyšetřování HIV protilátek v ČR dle registru SZÚ (NRL AIDS) k 31.12. 2002."— Presentation transcript:

1 Celkový stav vyšetřování HIV protilátek v ČR dle registru SZÚ (NRL AIDS) k 31.12. 2002

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3 Co změnit ? (1) zvýšit počet vyšetřených IUD na centrech určených právě pro ně zajistit co nejvyšší dostupnost HIV/HBV/HCV testů v těchto zařízeních zajistit vyšetření včas (akutní HIV infekce !), poskytnutí poradenství a následnou terapii a péči výběr testu orientovat více podle typu a potřeb klienta – v případě obav z nedostavení se pro výsledek či pokračování v rizikovém chování nabídnout vyšetření rychlými dg. testy i tam kde dostupné ELISA/slinné testy

4 Co změnit ? (2) kvalitním poradenstvím vést klienta k dispenzarizaci a léčbě, které jsou ostatně dle zák. č. 258/2000 Sb. povinné HAART u nadále se rizikově chovajících osob představuje i intervenci epidemiologickou omezující riziko dalšího šíření infekce zaměřit se i kontakty klientů a osoby v riziku primárně nespolupracující – terénní sociální práce a cílené poradenství uvědomit si, že lepší je test jednoduchý/rychlý (když nejde provést složitý/pomalý) než test žádný ….

5 Dg. HIV, HBV a HCV v nízkoprahových zařízeních, 2002 Služba počet zařízení HIV z kapilár. krve 23 HIV z žilní krve 15 HIV ze slin 18 HBV z kapilární krve 25 HBV z žilní krve 13 HCV z kapilární krve 29 HCV z žilní krve 13 zdroj: NMS, odpovědělo 65 ze 75 oslovených zařízení

6 Weekly epidemiological report, No. 42, 1998, s. 321 - 326 SIMPLE / RAPID TESTS … they can be carried out by staff with no formal laboratory training... … evidence that high quality simple/rapid tests have a similar performance to ELISA tests…

7 Weekly epidemiological report, No. 42, 1998, s. 321 - 326 SIMPLE / RAPID TESTS … with regard to their performance in the field, evaluations have shown that simple/rapid tests have been able to produce as ACCURATE or MORE ACCURATE results than ELISAs.

8 Weekly epidemiological report, No. 42, 1998, s. 321 - 326 SIMPLE / RAPID TESTS CONCLUSIONS: WHO recommends the use of reliable simple/rapid tests in settings where their operational characteristics make them more appropriate than ELISAs.

9 Ability of Untrained Users to Perform Rapid HIV Antibody Screening Tests Kevin P. Delaney, MPH, Bernard Branson, MD, and Carol Fridlund Centers for Disease Control and Prevention (CDC) Background: One-step rapid HIV antibody tests suitable for point-of-care testing offer many advantages if they can be performed in outreach settings by persons with minimal training. Purpose: To evaluate whether persons with no laboratory experience can successfully perform a rapid HIV test. Methods: Health care workers (including HIV counselors) without laboratory experience performed the OraQuick Rapid HIV Antibody test on specimens previously tested with EIA and Western blot (including strong positive, weak positive, and negative) after reading only the written instructions from the manufacturer. The number of correct results obtained with each specimen was recorded. Potential covariates, such as occupation and comfort with performing the test, were collected via questionnaire. Results: The 266 participants performed 1088 rapid tests. Seventy-eight tests (7.2%) were performed incorrectly and yielded no result. Of the remaining 1010 tests, participants obtained the correct result on 922 (91.3%). Fifty-nine (67%) of the 88 incorrect results, occurred with the same weak-positive specimen. Excluding tests with no result, participants obtained 220 (96.1%) correct results with strong positive specimens, 464 (97.3%) with negative specimens, and 144 (95.4%) with a different weak positive specimen. Stratified analyses showed consistent results across study sites and participant characteristics. Conclusions: Overall, untrained participants achieved 91.3% correct results with a rapid HIV antibody test (although performance was poorer with one weak-positive specimen.) By comparison, the Clinical Laboratory Improvement Amendments (CLIA) requires trained laboratory technicians to achieve an overall testing score of 80% correct on proficiency testing

10 FDA APPROVES NEW RAPID HIV TEST KIT HHS Secretary Tommy G. Thompson today announced that the U.S. Food and Drug Administration has approved a new rapid HIV diagnostic test kit that provides results with 99.6 percent accuracy in as little as 20 minutes. Using less than a drop of blood collected, this new test can quickly and reliably detect antibodies to HIV-1, the HIV virus that causes infection in most cases in the U.S. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings. The newly approved HIV test is called The OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., Bethlehem, Pennsylvania. "Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results," Secretary Thompson said. "With this new test, in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus." To perform the test, a fingerstick sample of blood is collected from an individual and transferred to a vial where it is mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional specific test. The OraQuick test has not been approved to screen blood donors. FDA currently categorizes the OraQuick test as "moderate complexity" under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Under CLIA, new tests are categorized as either moderate or high complexity. This designation means that the OraQuik test can only be given in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. If the test manufacturer applies for a CLIA waiver, the FDA can evaluate it for use under less stringent conditions. "I strongly urge the OraSure company to apply for a CLIA waiver," said Secretary Thompson, "If the FDA finds that the company's data proves that the OraQuick test is both easy and safe to use, it can get a CLIA waiver. Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers. But the process can't begin until OraSure applies for the waiver, so I ask them to please apply now!" The Centers for Disease Control and Prevention (CDC) has estimated that one fourth of the approximately 900,000 HIV-infected people in the U.S. are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services (CMS) are working with state and other health officials to make the test widely available and to offer technical assistance and counseling training for its use. "This test will be a great help in identifying pregnant HIV-infected women going into labor who were not tested during pregnancy so that precautionary steps can be take to block their newborns from being infected with HIV," said FDA Deputy Commissioner Dr. Lester M. Crawford. "It will also be a critical resource in helping identify HIV infection in health-care and emergency workers who are accidentally exposed to HIV- infected blood while doing their job."


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