TL;DR: Analytical performance data is reported for the novel Elecsys β‐amyloid (1–42) assay for Alzheimer's disease biomarker amyloid‐beta 1–42 in cerebrospinal fluid.
Abstract: Introduction Available assays for quantitation of the Alzheimer's disease (AD) biomarker amyloid-beta 1–42 (Aβ [1–42]) in cerebrospinal fluid demonstrate significant variability and lack of standardization to reference measurement procedures (RMPs). We report analytical performance data for the novel Elecsys β-amyloid (1–42) assay (Roche Diagnostics). Methods Lot-to-lot comparability was tested using method comparison. Performance parameters were measured according to Clinical & Laboratory Standards Institute (CLSI) guidelines. The assay was standardized to a Joint Committee for Traceability in Laboratory Medicine (JCTLM) approved RMP. Results Limit of quantitation was 0.995; bias in medical decision area Discussion The Elecsys β-amyloid (1–42) assay has high analytical performance that may improve biomarker-based AD diagnosis.
TL;DR: The limitation of real-time PCR to span the entire diversity of HIV must be taken into account during treatment monitoring, resistance studies, and clinical trials.
Abstract: OBJECTIVES We conducted a comparison of the Abbott Molecular RealTime (Rungis, France) and Roche Diagnostics Cobas Taqman (Meylan, France) automated nucleic acid extraction and real-time polymerase chain reaction (PCR) amplification systems for their capacity to quantify HIV RNA of various subtypes. The systems were tested on culture supernatants belonging to HIV-1 group M (n = 29), HIV-1 group O (n = 8), and HIV-2 (n = 7). We also tested 88 plasma samples from patients infected with HIV-1 group M (B-D [n = 7], A-CRF01 [n = 16], CRF02 [n = 49], and other strains [n = 16]). RESULTS The Abbott RealTime system quantified all 29 HIV-1 group M supernatants. One of these samples was not detected by the Roche Cobas TaqMan system. The Abbott RealTime system quantified 7 HIV-1 group O strains. Neither technique cross-reacted with HIV-2. The 79% intraclass correlation coefficient for the 88 plasma samples was barely acceptable, but 4 plasma samples were underestimated by more than 1 log by the Roche Cobas TaqMan system. Similar values were obtained for subtype B and D strains with the tests, indicating that the primers and probes are suitable for these strains. In contrast, the large differences observed with other subtypes, particularly CRF02, show the importance of primer and probe selection. CONCLUSION The limitation of real-time PCR to span the entire diversity of HIV must be taken into account during treatment monitoring, resistance studies, and clinical trials.
TL;DR: A.L.M.N., a former employee of BRAHMS GmbH, and N.G.B.M., former employees and former employees of Inverness Medical (Biosite) as mentioned in this paper, have received research grants from the Swiss National Institutes of Health (SNI), the Swiss Heart Foundation, the Novartis Foundation, and the Krokus Foundation.
Abstract: A.M., research support from Roche, Biosite,
and Bayer; consultant for Biosite. S.-X.N., consultant for ThermoFisher
Scientific. C.M., research grants from The Swiss National
Science Foundation, the Swiss Heart Foundation, the Novartis
Foundation, the Krokus Foundation, Abbott, Biosite, BRAHMS,
Roche, and the University of Basel. R.M.N., research support
from BRAHMS. W.F.P., Scientific Advisory Board of Abbott,
Beckman-Coulter, Biosite, Inverness, Ortho Clinical Diagnostics,
and Response Biomedical; research grants from Abbott, Biosite,
and Inverness. M.R., Scientific Advisory Board of Inverness
Medical; travel support, honoraria, and research grants from
Roche Diagnostics and Inverness Medical (Biosite). G.S.F., research
support from Biosite, BRAHMS, and Roche. S.D.S., consultant for
Biosite. L.L.N., research support from BRAHMS, Inverness, and
Medical Innovations. L.B.D., research grant from Roche. O.H.,
employee of BRAHMS GmbH. A.B. and N.G.M., former employees
of BRAHMS GmbH. S.D.A., research support from BRAHMS; honoraria
from Abbott and Biosite; consultant for BRAHMS.
TL;DR: The Cobas Liat influenza A and B assays demonstrated sensitivities of 99.2% (123/124) and 100% (23/23), respectively, while showing a specificity of 100% for each target.
Abstract: We compared an FDA-cleared rapid (<20 min) PCR assay (Cobas Liat; Roche Diagnostics) to our routine influenza A and B real-time PCR assay (Simplexa Flu A/B & RSV Direct; Focus Diagnostics) using respiratory swabs (n = 197). The Cobas Liat influenza A and B assays demonstrated sensitivities of 99.2% (123/124) and 100% (23/23), respectively, while showing a specificity of 100% for each target.
TL;DR: The application of multiplex PCR for the detection of multiple pathogens within the same sample will provide a major contribution to the efficiency, logistics and cost-effectiveness of molecular diagnostics.