Extensive evaluation of a seronegative participant in an HIV-1 vaccine trial as a result of false-positive PCR

Schwartz, David H.; Laeyendecker, Oliver; Arango-Jaramillo, Silvio; Castillo, Renan C.; Reynolds, Mary Jane

doi:10.1016/s0140-6736(97)01500-6

Cited by 23 publications

(19 citation statements)

References 12 publications

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“…Because of the possibility of low-level false-positive results, these plasma viral load assays should not be used for the routine diagnosis of HIV-1 infections without additional laboratory and clinical information (5,10,12,13,16). The enzyme-linked immunosorbent assay (ELISA) screen for HIV antibodies followed by Western blot confirmation provides a greater than 99% accuracy for detection of HIV infections but may give negative or indeterminate results during the primary infection for 3 to 4 weeks prior to seroconversion (12,13).…”

Section: Discussionmentioning

confidence: 99%

“…False-positive HIV-1 RNA levels are typically at the low end of the range of detection, while during acute infection, the levels of virus are usually quite high (12). There is one report, however, of a false-positive RT-PCR result of 10 4 to 10 5 copies/ml from the serum of an HIV-1 vaccine recipient (16). With the bDNA assay, false-positive results may occur at least 2 to 6% of the time due to factors including the non specificity of the assay chemistry (5, 12) as well as specimen misidentifications and laboratory errors (13).…”

Section: Discussionmentioning

confidence: 99%

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Intra- and Interlaboratory Variabilities of Results Obtained with the Quantiplex Human Immunodeficiency Virus Type 1 RNA bDNA Assay, Version 3.0

Kellogg

Atria²,

Sanders

et al. 2001

Clin Diagn Lab Immunol

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Normal assay variation associated with bDNA tests for human immunodeficiency virus type 1 (HIV-1) RNA performed at two laboratories with different levels of test experience was investigated. Two 5-ml aliquots of blood in EDTA tubes were collected from each patient for whom the HIV-1 bDNA test was ordered. Blood was stored for no more than 4 h at room temperature prior to plasma separation. Plasma was stored at ؊70°C until transported to the Central Pennsylvania Alliance Laboratory (CPAL; York, Pa.) and to the Hershey Medical Center (Hershey, Pa.) on dry ice. Samples were stored at <؊70°C at both laboratories prior to testing. Pools of negative (donor), low-HIV-1-RNA-positive, and high-HIV-1-RNA-positive plasma samples were also repeatedly tested at CPAL to determine both intra-and interrun variation. From 11 August 1999 until 14 September 2000, 448 patient specimens were analyzed in parallel at CPAL and Hershey. From 206 samples with results of >1,000 copies/ml at CPAL, 148 (72%) of the results varied by <0.20 log 10 when tested at Hershey and none varied by >0.50 log 10 . However, of 242 specimens with results of <1,000 copies/ml at CPAL, 11 (5%) of the results varied by >0.50 log 10 when tested at Hershey. Of 38 aliquots of HIV-1 RNA pool negative samples included in 13 CPAL bDNA runs, 37 (97%) gave results of <50 copies/ml and 1 (3%) gave a result of 114 copies/ml. Low-positive HIV-1 RNA pool intrarun variation ranged from 0.06 to 0.26 log 10 while the maximum interrun variation was 0.52 log 10 . High-positive HIV-1 RNA pool intrarun variation ranged from 0.04 to 0.32 log 10 , while the maximum interrun variation was 0.55 log 10 . In our patient population, a change in bDNA HIV-1 RNA results of <0.50 log 10 over time most likely represents normal laboratory test variation. However, a change of >0.50 log 10 , especially if the results are >1,000 copies/ml, is likely to be significant.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Intra- and Interlaboratory Variabilities of Results Obtained with the Quantiplex Human Immunodeficiency Virus Type 1 RNA bDNA Assay, Version 3.0

Kellogg

Atria²,

Sanders

et al. 2001

Clin Diagn Lab Immunol

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show abstract

“…A infecção primária pelo HIV-1 é caracterizada por numerosos sintomas clínicos (12,14). Um diagnóstico rápido pode dificultar a transmissão (7) e permitir a instituição de um tratamento precoce (9,13).…”

Section: Jornal Brasileiro De Patologia E Medicina Laboratorialunclassified

Avaliação de ensaio molecular para determinação de carga viral em indivíduos sorologicamente negativos para o HIV-1

Pereira¹,

Silva²,

Porto³

et al. 2002

J. Bras. Patol. Med. Lab.

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16). Como exemplo tem sido relatado que 2% a 15% dos pacientes soropositivos para HIV-1 apresentam resultados negativos na "altamente sensível" reação em cadeia da polimerase (PCR) (1, 4, 6).O problema é que qualquer teste de laboratório tem não somente um, mas dois tipos de sensibilidade e especificidade: analítico e diagnóstico. A despeito de importantes diferenças entre a sensibilidade analítica e a sensibilidade diagnóstica, esses termos são usados, no meio clínico, como sinônimos, sem distinção de seus respectivos adjetivos. A compreensão dos dife- IntroduçãoOs termos "sensibilidade" e "especificidade" têm sido usados em diferentes contextos. O termo "ultrasensível" foi introduzido em diagnóstico molecular para descrever um ensaio que oferecia "maior sensibilidade" em relação ao seu antecessor (2). Alguns clínicos têm, ao menos, uma noção intuitiva desses conceitos, mas apresentam limitações para interpretá-los corretamente. Considerável confusão ocorre quando um ensaio "altamente sensível" freqüentemente passa como negativo (6), ou quando um teste "altamente específico" fornece um resultado falso-positivo (11, 12,

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“…1 Vaccine-induced seropositivity (VISP) is a common outcome of HIV vaccine trials, 2 mostly associated with vaccines containing envelope inserts. [2][3][4][5][6] Current HIV screening policy relies on highly sensitive enzyme immunoassays detecting antibodies against different proteins, most often p24, HIV-1 gp41 and HIV-2 gp36. Although 4th generation tests reduce the size of the diagnostic window by combining HIV antibody and p24 antigen detection, 7-10 many clinical laboratories still use 3rd generation assays.…”

Section: Introductionmentioning

confidence: 99%

Vaccine-induced HIV seropositivity: A problem on the rise

Braeckel

Koutsoukos

Bourguignon

et al. 2011

Journal of Clinical Virology

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Interpretation of HIV test results is becoming increasingly complex with the growing number of volunteers participating in prophylactic HIV vaccine trials worldwide and the rising number of viral antigens included in these vaccine candidates. The results of this study in recipients of a highly immunogenic adjuvanted polyprotein HIV vaccine candidate devoid of envelope proteins, illustrate the increasing need for approaches that can discriminate HIV infection-induced antibodies from those elicited by a vaccine.

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Extensive evaluation of a seronegative participant in an HIV-1 vaccine trial as a result of false-positive PCR

Cited by 23 publications

References 12 publications

Intra- and Interlaboratory Variabilities of Results Obtained with the Quantiplex Human Immunodeficiency Virus Type 1 RNA bDNA Assay, Version 3.0

Intra- and Interlaboratory Variabilities of Results Obtained with the Quantiplex Human Immunodeficiency Virus Type 1 RNA bDNA Assay, Version 3.0

Avaliação de ensaio molecular para determinação de carga viral em indivíduos sorologicamente negativos para o HIV-1

Vaccine-induced HIV seropositivity: A problem on the rise

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