Workflow and Maintenance Characteristics of Five Automated Laboratory Instruments for the Diagnosis of Sexually Transmitted Infections

Ratnam, Sam; Jang, Dan; Gilchrist, Jodi; Śmieja, Marek; Poirier, André; Hatchette, Todd F.; Flandin, Jean Frederic; Chernesky, Max

doi:10.1128/jcm.03549-13

Cited by 24 publications

(22 citation statements)

References 17 publications

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“…In addition, it also has unique features such as controls that can be used over a 24-h period and stability of the reagents onboard for 72 h. Hence, the fully automated Panther system with random access has all the necessary features required for clinical laboratories demanding high-throughput sample processing with improved workflow and less turnaround time. Our findings were in concordance with those of other studies reporting workflow and maintenance characteristics (18,27) of various HIV diagnostic platforms.…”

Section: Discussionsupporting

confidence: 83%

Evaluation of Performance Characteristics of the Aptima HIV-1 Quant Dx Assay for Detection and Quantitation of Human Immunodeficiency Virus Type 1 in Plasma and Cervicovaginal Lavage Samples

et al. 2016

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bQuantification of HIV-1 RNA has become the standard of care in the clinical management of HIV-1-infected individuals. The objective of this study was to evaluate performance characteristics and relative workflow of the Aptima HIV-1 Quant Dx assay in comparison with the Abbott RealTime HIV-1 assay using plasma and cervicovaginal lavage (CVL) specimens. Assay performance was evaluated by using an AcroMetrix HIV-1 panel, AcroMetrix positive controls, Qnostics and SeraCare HIV-1 evaluation panels, 208 clinical plasma samples, and 205 matched CVL specimens on the Panther and m2000 platforms. The Aptima assay demonstrated good linearity over the quantification range tested (2 to 5 log 10 copies/ml), and there was strong linear correlation between the assays (R 2 ‫؍‬ 0.99), with a comparable coefficient of variance of <5.5%. For the plasma samples, Deming regression analyses and Bland-Altman plots showed excellent agreement between the assays, with an interassay concordance of 91.35% (kappa ‫؍‬ 0.75; 95% confidence interval [CI], 0.65 to 0.85), and on average, the viral loads determined by the Aptima assay were 0.21 log 10 copies/ml higher than those determined by the RealTime assay. The assays differed in their sensitivity for quantifying HIV-1 RNA loads in CVL samples, with the Aptima and RealTime assays detecting 30% and 20%, respectively. Aptima had fewer invalid results, and on average, the viral loads in CVL samples quantified by the Aptima assay were 0.072 log 10 copies/ml higher than those of the RealTime assay. Our results demonstrate that the Aptima assay is sensitive and accurate in quantifying viral loads in both plasma and CVL specimens and that the fully automated Panther system has all the necessary features suitable for clinical laboratories demanding high-throughput sample processing. Q uantitation of HIV-1 RNA has been an established surrogate marker for monitoring viral suppression and drug efficacy during antiretroviral therapy (ART) in HIV-infected patients. Early diagnosis during the acute phase of infection represents a tremendous opportunity for treatment and prevention interventions, as the HIV-1 concentration in both plasma and genital fluids is intensely high during this phase (1, 2). It is apparent from previous studies that plasma viral load has been an important determinant in detecting HIV-1 in the genital tract (3-5). RNA levels in cervicovaginal lavage (CVL) specimens are usually lower than plasma HIV-1 RNA loads; thus, HIV-1 RNA suppression in the genital tract may occur more rapidly than in plasma after initiation of therapy (6). Nevertheless, more recent studies demonstrate that genital HIV-1 RNA shedding occurs in women on highly active antiretroviral therapy (HAART) even in the absence of plasma viremia (7,8). Therefore, an HIV-1 assay that accurately quantifies both genital and plasma RNA levels is a powerful research tool to better understand HIV-1 pathogenesis in the genital tract. Measurement of HIV-1 loads in CVL samples is challenging due to the presence of inhibitors of amp...

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Section: Discussionsupporting

confidence: 83%

Evaluation of Performance Characteristics of the Aptima HIV-1 Quant Dx Assay for Detection and Quantitation of Human Immunodeficiency Virus Type 1 in Plasma and Cervicovaginal Lavage Samples

et al. 2016

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“…Results from each testing site were sent electronically to the IRL, where they were transferred into a Microsoft Excel database. During this study, workflow and maintenance characteristics of each automated instrument were determined (18).…”

Section: Methodsmentioning

confidence: 99%

Head-to-Head Comparison of Second-Generation Nucleic Acid Amplification Tests for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae on Urine Samples from Female Subjects and Self-Collected Vaginal Swabs

et al. 2014

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f In a comparison of 4 second-generation nucleic acid amplification tests performed with self-collected vaginal swab (SCVS) and first-void urine (FVU) specimens from 575 women, SCVS specimens indicated more infections than did FVU specimens in all assays. The prevalence rates were 9% (53/575 patients) for Chlamydia trachomatis and 2% (11/575 patients) for Neisseria gonorrhoeae. The clinical sensitivities for testing SCVS specimens for C. trachomatis were 98.1% on a Tigris system and 96.2% on a Panther system for the Aptima Combo 2 assay (Hologic Gen-Probe), 98.0% for the RealTime CT/NG assay on an m2000 instrument (Abbott), 90.6% for the ProbeTec CT/GC Q x assay on the Viper system (Becton Dickinson), and 84.6% for the cobas CT/NG assay on the cobas 4800 platform (Roche). Clinical sensitivities for C. trachomatis in FVU specimens were 88.7% (Tigris) and 88.0% (Panther) for the Aptima Combo 2 assay, 76.9% for the RealTime CT/NG assay, 75.5% for the ProbeTec CT/GC Q C hlamydia trachomatis and Neisseria gonorrhoeae infections of the female genital tract present a diagnostic challenge because many patients are asymptomatic (1, 2). This has led to implementation of screening strategies using less-invasive sampling procedures (3, 4), and screening programs often increase the number of samples received in the laboratory (5). Nucleic acid amplification tests (NAATs) for C. trachomatis and N. gonorrhoeae diagnosis have been available from commercial sources for over 15 years. The first PCR assay from Roche was the semiautomated Amplicor CT/NG test (6), which evolved into the automated cobas Amplicor assay. The ligase chain reaction assay (Abbott LCX) was the second NAAT to be used extensively but was withdrawn globally in 2003. A first-generation strand-displacement assay called ProbeTec ET, from Becton Dickinson, became available for evaluation in 1999. During the same time frame, a first-generation transcription-mediated amplification test was developed by GenProbe and evolved into the second-generation Gen-Probe Aptima Combo 2 (AC2) assay, which was evaluated with female specimens and was reported in 2003 (7). More recently, the U.S. Food and Drug Administration (FDA) cleared three additional secondgeneration assays and automated instruments, namely, the Abbott Molecular RealTime CT/NG assay on the m2000 instrument, the Becton Dickinson ProbeTec CT/GC Q x assay on the Viper XTR instrument, and the Roche Diagnostics cobas CT/NG assay on the cobas 4800 instrument.Examination of the package inserts for these newer secondgeneration assays indicated that FDA clearance was granted by comparing the new assays with patient-infected status (PIS) results, with infection being based on positive results from at least two cleared assays when 2 different specimen types were tested.The cobas CT/NG assay was compared with two other secondgeneration assays (AC2 and ProbeTec CT/GC Q x assays) (8, 9). The AC2 test and the first-generation ProbeTec ET assay were chosen for the RealTime CT/NG performance studies (10) and the ProbeTec CT/G...

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“…The Aptima assay demonstrated good performance, sensitivity, precision, and reliability, in addition to an excellent clinical agreement. Combined with full automation, high throughput, and superior workflow, Aptima‐HIV‐1 is suitable for VL monitoring of HIV‐1 patients during treatment.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Aptima HIV‐1 Quant Dx assay with the COBAS AmpliPrep/COBAS TaqMan HIV‐1 v2.0 Test for HIV‐1 viral load quantification in plasma samples from HIV‐1–infected patients

Longo

Bon

Musumeci

et al. 2018

Health Science Reports

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Background and aimsHIV‐1 RNA viral load (VL) in plasma samples of HIV‐1–positive patients is used to assess the level of viral replication, the risk of disease progression, and the response and efficacy to antiretroviral treatment. Knowing the performance of different tests for HIV‐1 RNA detection is, therefore, important for clinical care. This study compared the performance of the recently introduced Aptima HIV‐1 Quant Dx assay (Hologic, Inc) and the standard COBAS AmpliPrep/COBAS TaqMan HIV‐1 v2.0 Test (CAP/CTM2) (Roche Molecular System, Inc) for HIV‐1 RNA quantitation.MethodsAssay performance was assessed using 335 clinical samples, a standard HIV‐1 low VL panel, and 2 diluted samples from well‐characterized patients infected with different HIV‐1 subtypes tested in 5 replicates over 3 days. All samples were tested on both assays to evaluate inter‐assay agreement, both qualitatively and quantitively. Altogether, we evaluated assay sensitivity, linearity, accuracy, precision, repeatability, and reproducibility.ResultsAssay agreement for qualitative results in 335 clinical samples was fair (80.6%). Correlation of quantitative assay results (n = 164) was excellent (R 2 = 0.97), with 96.3% of the results within the 95% limit of assay agreement (−0.42 to +0.86 log), and 98.8% within 1 log of each other. Aptima‐HIV‐1 yielded results, on average, 0.22 log higher than CAP/CTM2. Both assays accurately quantitated the HIV‐1 standard at low VL (R 2 ≥ 0.94), with all samples within 0.5 log of the target.ConclusionAptima‐HIV‐1 assay demonstrated sensitivity, accuracy, reproducibility, and precision for the detection and quantitation of HIV‐1 RNA across a wide dynamic range of VLs. Its performance, together with full automation and high throughput, suggests that Aptima‐HIV‐1 could be a suitable assay for reliable monitoring of HIV‐1 VL in patients undergoing treatment.

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Workflow and Maintenance Characteristics of Five Automated Laboratory Instruments for the Diagnosis of Sexually Transmitted Infections

Cited by 24 publications

References 17 publications

Evaluation of Performance Characteristics of the Aptima HIV-1 Quant Dx Assay for Detection and Quantitation of Human Immunodeficiency Virus Type 1 in Plasma and Cervicovaginal Lavage Samples

Evaluation of Performance Characteristics of the Aptima HIV-1 Quant Dx Assay for Detection and Quantitation of Human Immunodeficiency Virus Type 1 in Plasma and Cervicovaginal Lavage Samples

Head-to-Head Comparison of Second-Generation Nucleic Acid Amplification Tests for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae on Urine Samples from Female Subjects and Self-Collected Vaginal Swabs

Comparison of the Aptima HIV‐1 Quant Dx assay with the COBAS AmpliPrep/COBAS TaqMan HIV‐1 v2.0 Test for HIV‐1 viral load quantification in plasma samples from HIV‐1–infected patients

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