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오민식

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2022-12-29

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Testing technology
Recommendations
• We recommend that clinic policies and patient information regarding the HIV test window period should be based on 99th percentile estimates; where a test is undertaken sooner than this time interval, window period data should be used to counsel patients as to the likelihood of a false-negative result (GPP).
• We recommend that the following window periods are applied when utilising these tests (Grade 1A):
o Fourth-generation laboratory tests, 45 days;
o Third-generation laboratory tests, 60 days;
o All POCTs (including Determine HIV-1/2 Ab (third generation), INSTI HIV-1/2 Test and the OraQuick Rapid HIV-1/2 antibody Test), 90 days.
• Confirmatory testing should be undertaken according to locally determined pathways in liaison with local virology teams (GPP).
• Molecular assays (viral RNA or proviral DNA) are not recommended for routine diagnosis though this may change as evidence and/or assay approvals evolve (Grade 1B).
• We recommend molecular assays for diagnostic uncertainty (e.g. primary HIV or indeterminate serology on PrEP) via locally determined pathways in liaison with local virology teams (Grade 1B).
There are two methods for routine HIV testing: (i) laboratory-based tests performed on samples obtained through venepuncture; and (ii) self-sampling, self-testing and rapid POCTs which can be performed in the clinic, in the community setting or as a home test.
The window period of a test can be defined as the time interval between exposure to infection and accurate detection of that infection; the window period ends when HIV can be detected consistently by the test in question [71]. Knowledge of window periods guides clinicians to offer the appropriate test, at the most appropriate time, and to advise patients accordingly. Factors governing the window period include characteristics of the virus, the test and the exposed individual’s immune response [71]. HIV tests have evolved considerably since the start of the epidemic, yielding progressive reduction in window periods over time [72] (see Appendix 2 for definitions of HIV tests).
Consensus guidelines recommend fourth-generation HIV laboratory tests with venous sampling as the first-line choice, with POCTs also available (which are largely third-generation tests) [13,72-74]. Confirmatory testing should be undertaken according to locally determined pathways in liaison with local virology teams.
We do not recommend molecular assays (viral RNA or proviral DNA) as part of routine diagnostic algorithms though this may change as evidence and/or assay approvals evolve.
We suggest the use of molecular assays in cases of diagnostic uncertainty (e.g. primary HIV or indeterminate serology on PrEP) via locally determined pathways in liaison with local virology teams.
Evidence review
A literature review revealed two recent studies that specifically addressed window periods for different HIV screening tests and the implications for interpreting results and counselling patients.
Taylor et al. [75] reviewed data from commercial and literature-reported seroconversion panels to calculate the window period for third- and fourth-generation tests and calculate the probability of a false- negative test result during the window period. For third-generation tests the cumulative probability of a false-negative HIV test result was 5%, 1% and 0% by 40, 85 and 99 days post-exposure, respectively, and for fourth-generation tests the corresponding intervals were 34, 42 and 50 days. Rapid POCTs were excluded from this analysis and are expected to have longer window periods than laboratory-based investigations.
Delaney et al. [71] evaluated 20 US Food and Drug Administration (FDA)-approved HIV immunoassays against the Aptima HIV-1 RNA test (the only HIV-1 nucleic acid test approved for diagnosis by the FDA) using 222 longitudinal samples from 25 HIV seroconvertors in the USA. Time between detection of HIV RNA and reactive immunoassay results was combined with simulated eclipse period (time from exposure to HIV RNA detection) data to estimate the window period for each test. The median window period data for each type of screening test are presented in Table 1 including 99th percentile values (i.e. the number of days post-exposure by which time 99% of HIV infections would yield a reactive result).

Table 1 Estimated median, interquartile range (IQR) and 99th percentile window period by test type
Type (no. of inclusive tests) Median (IQR), days 99th percentile, days Antibody/antigen laboratory (4) (fourth-generation laboratory test) 17.8 (13.0–23.6) 44.3 IgG/IgM-sensitive laboratory (3) (third-generation laboratory test) 23.1 (18.4–28.8) 49.5 IgG-sensitive rapid screening (6) (third-generation POCT) 31.1 (26.2–37.0) 56.7 IgG-sensitive supplemental (2) 33.4 (28.5–39.2) 58.2 Western blot (viral lysate) (1) 36.5 (31.0–43.2) 64.8

The authors concluded that 99% of HIV infections would be identified by fourth-generation tests by 45 days post-exposure, and most by 50 days post-exposure using third-generation tests. All tests were capable of detecting infection by 90 days post-exposure.

이렇게 의학논문에서도 4세대는 50일지나면 위음성확률 0%..라는데......

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2022-12-30

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