An improved method for monitoring efficacy of anti‐retroviral therapy in HIV‐infected individuals: A highly sensitive HIV p24 antigen assay

Reddy, Mohan M.; Winger, Edward E.; Hargrove, David; McHugh, Thomas M.; McKinley, George; Grieco, Michael H.

doi:10.1002/jcla.1860060305

Cited by 13 publications

(5 citation statements)

References 22 publications

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“…The HIV-1-encoded gag gene product, p24, is one of the first virally encoded molecules detectable in the circulation of infected persons and has been used as a prognostic marker to predict the progression of HIV-1-related disease. Although a correlation between p24 antigenemia in blood and disease stage has been well established (2,8,20,31), a lack of detectable p24 antigen in asymptomatic persons seropositive for HIV-1 (28,34) and even in symptomatic patients (21) limits its use.…”

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confidence: 99%

Comparative evaluation of NASBA HIV-1 RNA QT, AMPLICOR-HIV monitor, and QUANTIPLEX HIV RNA assay, three methods for quantification of human immunodeficiency virus type 1 RNA in plasma

et al. 1996

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Three commercial assays for quantifying plasma human immunodeficiency virus type 1 (HIV-1) RNA were evaluated. The assays differed in their sample volumes, the means of preparing samples, and methods of amplification and detection. Plasma samples were obtained from 36 HIV-1-infected patients representing all stages of HIV-1 infection and were analyzed as coded specimens. Measurement of HIV-1 RNA baseline levels revealed no significant difference in sensitivity between the three assays. The assays were also applied to the quantitation of HIV-1 RNA levels in the plasma of patients who were changing their antiretroviral therapy. The changes measured in HIV-1 RNA levels in plasma in response to therapy were comparable by the three assays. No close correlation was found between the amount of HIV-1 RNA and the CD4 T-cell count;HIV-1 RNA assays were more sensitive than p24 antigen assays as an indicator of plasma viremia. Overall, the study demonstrates that all three quantitative assays for HIV-1 RNA can be used to measure the HIV-1 RNA copy number representing the HIV-1 viremia status in patients with HIV-1 infection. Since this copy number is likely to be useful in monitoring the effectiveness of antiviral therapy, these quantitative assays for HIV-1 RNA are ready to be built into clinical trials.

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confidence: 99%

Comparative evaluation of NASBA HIV-1 RNA QT, AMPLICOR-HIV monitor, and QUANTIPLEX HIV RNA assay, three methods for quantification of human immunodeficiency virus type 1 RNA in plasma

et al. 1996

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“…The poor sensitivity of the standard antigen assay is thought to be due in part to the variable amounts of antigen frequently complexed with antibody (6,8,18). Disruption of HIV-1 antigen-antibody immune complexes has been proposed as a means of increasing the number of HIV-1-infected individuals with detectable levels of antigen (2,4,5,7,(9)(10)(11)(13)(14)(15)(16). In this modification of the standard antigen assay, the immune-complex-dissociated (ICD) antigen assay, disruption of antigen-antibody complexes is accomplished by acid and/or heat treatment of serum or plasma samples prior to performance of the routine antigen assay.…”

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confidence: 99%

“…Although the ICD antigen assay has been found to be more sensitive than the standard antigen assay (9-11, 13, 19) and has been used as a marker of disease progression and therapeutic response (2,14), the stabilities of free and complexed antigens under various storage conditions are not known. Definition of optimum storage and transport conditions for samples collected for HIV-1 antigen testing is important for laboratories that perform HIV-1 antigen assays on samples collected at other sites and for laboratories that are involved in therapeutic trials.…”

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confidence: 99%

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Stability of free and complexed human immunodeficiency virus type 1 antigen at 4 degrees C and at room temperature

Griffith¹,

Garner²,

Chacko³

1995

J Clin Microbiol

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Free and immune-complex-dissociated (ICD) human immunodeficiency virus type 1 (HIV-1) antigenemias in serum specimens stored at room temperature (RT) and 4 degrees C for 1 to 35 days were evaluated. At all time points examined, there was no significant loss in detectable levels of ICD HIV-1 antigen at either RT or 4 degrees C. Free HIV-1 antigen was not stable in serum samples stored at RT for more than 2 days but was stable in samples stored at 4 degrees C for up to 4 days. Loss of free antigen occurred more rapidly in samples with high antigen content at baseline. Use of the ICD antigen assay allowed accurate quantitation of antigen in samples stored at RT or 4 degrees C for as long as 1 month.

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“…Measurements of circulating cell-free virus by assays including those for p24 antigen and quantitative plasma cultures have been examined as risk factors for progression of clinical disease (5,6,9,15,23); however, serum p24 antigen and positive plasma cultures have been detected consistently only in symptomatic individuals with relatively advanced disease. Although p24 antigen measurements have been improved through the use of immune complex disassociation techniques, even immune complex disassociation p24 antigen assays are relatively insensitive in asymptomatic patients (17,22). Plasma culture techniques are time-consuming and expensive and generally have limited sensitivity in asymptomatic individuals who have little plasma virus that can be measured by limiting dilution cultures (15,23).…”

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Biological variation and quality control of plasma human immunodeficiency virus type 1 RNA quantitation by reverse transcriptase polymerase chain reaction

et al. 1993

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Quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in the plasma of seropositive individuals was performed by using an external control assay with techniques to standardize and control each measurement. Rigorous study of the variability of the assay showed that the median intraassay reproducibility was log1o 0.15 RNA copies per ml of plasma, while the median interassay reproducibility on replicate plasma samples was log1o 0.25 copies per ml. Specimen stability studies showed reproducible recovery of RNA from plasma stored at-70°C for up to 12 months. In clinically stable patients who were either untreated or taking zidovudine, the average week-to-week variation in plasma RNA levels, measured in real time, was log1o 0.30 RNA copies per ml. In contrast, patients either initiating or changing antiretroviral therapy showed a fall of loglo 0.8 to log1o 2.0 copies per ml in plasma RNA levels. Overall, 105 of 110 (96%) HIV-1-seropositive individuals with CD4 counts of 36 to 868 cells per mm3 had quantifiable HIV-1 RNA over a range of log1o 2.70 to loglo 6.23 RNA copies per ml, including 81% (13 of 16) of the individuals with greater than 500 CD4 cells per mm3. Accurate and reproducible quantitation of plasma viremia in real time by reverse transcriptase polymerase chain reaction, particularly in asymptomatic HIV-1-infected individuals with high CD4 counts, provides a basis for the use of this virologic measure to monitor the short-and long-term effects of early intervention therapeutic strategies on viral burden.

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An improved method for monitoring efficacy of anti‐retroviral therapy in HIV‐infected individuals: A highly sensitive HIV p24 antigen assay

Cited by 13 publications

References 22 publications

Comparative evaluation of NASBA HIV-1 RNA QT, AMPLICOR-HIV monitor, and QUANTIPLEX HIV RNA assay, three methods for quantification of human immunodeficiency virus type 1 RNA in plasma

Comparative evaluation of NASBA HIV-1 RNA QT, AMPLICOR-HIV monitor, and QUANTIPLEX HIV RNA assay, three methods for quantification of human immunodeficiency virus type 1 RNA in plasma

Stability of free and complexed human immunodeficiency virus type 1 antigen at 4 degrees C and at room temperature

Biological variation and quality control of plasma human immunodeficiency virus type 1 RNA quantitation by reverse transcriptase polymerase chain reaction

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