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A Single-centre Study of COVID-19 Antibody.

J Coll Physicians Surg Pak 2021 Jan;31(1):S55-S56

Department of Haematology, Col Sultan's Lab, Sialkot Cantt, Pakistan.

ABSTARCT Four hundred and fifty-three SARS CoV-2 antibodies tests were conducted using Roche Elecsys® Anti SARS CoV-2 kits (detecting total antibodies) between June 13 to July 8, 2020 (25 days) on Cobas® e411 automatic analyser, based on electrochemiluminescence immunoassay (ECLIA) principle. Samples were collected from walk-in patients at our facility. Among them, 2 (0. Read More

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January 2021

Toward 2-Thiophyne: Ketocarbene versus Hetaryne Intermediates from 2-(Trimethylsilyl)thiophen-3-yl Triflate.

Org Lett 2021 Sep 13. Epub 2021 Sep 13.

Centro Singular de Investigación en Química Biolóxica e Materiais Moleculares (CIQUS), Universidade de Santiago de Compostela, 15782 Santiago de Compostela, Spain.

The reaction of 2-(trimethylsilyl)thiophen-3-yl triflate with CsF in the presence of 2,3,4,5-tetraphenylcyclopentadienone affords 4,5,6,7-tetraphenylbenzo[]thiophene, as it would be expected from the hypothesized generation and trapping of 2-thiophyne. However, a detailed experimental and computational study discards the intermediacy of this elusive 5-membered hetaryne. Instead, a complex mechanism involving the generation of an intermediate ketocarbene, which adds to the cyclopentadienone to give an isolable tricyclic intermediate, followed by thermal rearrangements, is proposed. Read More

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September 2021

Performance Analysis of Three Commercial Kits Designed for RNA Quantification of HIV-1 Group O Variants.

J Acquir Immune Defic Syndr 2021 Oct;88(2):220-227

Normandie Univ, UNIROUEN, EA2656, GRAM 2.0, et CHU de Rouen, Laboratoire de Virologie associé au CNR du VIH, Rouen, France; and.

Background: The genetic divergence of HIV-1 group O is high relative to pandemic group M, which could impact detection and quantification of plasma RNA. Recent commercial kits for RNA quantification seem to show good performances in HIV-1/O, but discrepancies are still observed. Here, we compare the performances of 3 commercial assays for the RNA quantification of HIV-1/O. Read More

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October 2021

Increased risk of prediabetes among virally suppressed adults with HIV in Central Kenya detected using glycated haemoglobin and fasting blood glucose.

Endocrinol Diabetes Metab 2021 Jul 17:e00292. Epub 2021 Jul 17.

Department of Global Health, University of Washington, Seattle, Washington, USA.

Aims: As survival among people living with HIV (PLHIV) improves with universal HIV treatment, new strategies are needed to support management of co-morbidities like type 2 diabetes (T2D). We assessed prediabetes and T2D prevalence and risk factors using haemoglobin A1c (HbA1c) among PLHIV on antiretroviral therapy (ART) in Central Kenya.

Methods: This cross-sectional study, conducted at a rural and urban site, enrolled PLHIV aged ≥35 years on ART for at least 5 years. Read More

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Early Antibody Temporal Responses to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Vaccinated Subjects Determined by the Cobas 6000 Spike Assay.

Arch Pathol Lab Med 2021 Sep 7. Epub 2021 Sep 7.

Department of Laboratory Medicine, Clinical Center, (Loving, Stallcup, Sacks, Harb) at the National Institutes of Health, Bethesda, MD.

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September 2021

Prevalence of undetectable and suppressed viral load in HIV-infected pregnant women initiating Option B+ in Uganda: an observational study nested within a randomized controlled trial.

BMC Infect Dis 2021 Sep 4;21(1):907. Epub 2021 Sep 4.

Makerere University - Johns Hopkins University Research Collaboration, P.O. Box 23491, Kampala, Uganda.

Background: Viral load (VL) testing is key in monitoring adherence to antiretroviral therapy (ART) and documenting HIV treatment response. As per HIV treatment guidelines in Uganda, the first VL test is recommended 6 months after initiation of ART. Undetectable VL (uVL) at ART initiation may be helpful in detecting elite controllers in the absence of previous ART use. Read More

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September 2021

[Comparison between Xpert® and COBAS® TaqMan® for the measuring of viral load of hepatitis B and C viruses].

Rev Chilena Infectol 2021 Jun;38(3):344-348

Departamento de Medicina Interna, Hospital Clínico Universidad de Chile, Santiago de Chile, Chile.

Background: The measurement of viral load (VL) of hepatitis B (HBV) and C (HCV) viruses is essential in the follow-up of patients with antiviral therapy. The most widely used methodology for this determination is COBAS®-TaqMan®. Recently, the Xpert® technology was developed and needs to be evaluated. Read More

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Variation in SARS-CoV-2 molecular test sensitivity by specimen types in a large sample of emergency department patients.

Am J Emerg Med 2021 Aug 17;50:381-387. Epub 2021 Aug 17.

Department of Research & Evaluation, Kaiser Permanente Southern California, 100 South Los Robles Avenue, Pasadena, CA 91101, USA.

Background: Provider-collected nasopharyngeal specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular testing are the standard of care in many clinical settings, but patient-collected saliva and anterior nares specimens are less invasive and more flexible alternatives. Prior studies comparing specimen types for SARS-CoV-2 molecular testing have been limited by small sample sizes and low pretest probability. We conducted a large observational study among symptomatic adults at 7 emergency departments of Kaiser Permanente Southern California to examine sensitivity of SARS-CoV-2 molecular tests by specimen type and patient characteristics. Read More

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Serum level of high sensitive C-reactive protein and IL - 6 markers in patients with treatment-resistant schizophrenia in Ethiopia: a comparative study.

BMC Psychiatry 2021 08 31;21(1):428. Epub 2021 Aug 31.

Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.

Background: Accumulating evidence indicates that schizophrenia is accompanied by significant activation of the immune system; however, there is limited data from low and middle-income countries (LMIC). Inflammatory markers may be more relevant in LMIC settings where infectious conditions are more prevalent and may thus play some role in the causation and maintenance of schizophrenia. The aim of this study was to assess the level of inflammatory markers high sensitive C-reactive protein (hsCRP) and interleukin-6 (IL-6) in patients with schizophrenia. Read More

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Analytical and Clinical Evaluation of the Semiquantitative Elecsys Anti-SARS-CoV-2 Spike Protein Receptor Binding Domain Antibody Assay on the Roche cobas e602 Analyzer.

Am J Clin Pathol 2021 Aug 31. Epub 2021 Aug 31.

Department of Pathology, University of Chicago, Chicago, IL, USA.

Objectives: To analytically and clinically evaluate the semiquantitative Elecsys anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein antibody (S-Ab) assay on the Roche cobas e602 analyzer.

Methods: The S-Ab assay is a 1-step, double-antigen sandwich electrochemiluminescent immunoassay that semiquantitatively measures total IgG, IgM, and IgA antibodies specific for the receptor binding domain of SARS-CoV-2 spike protein in serum or plasma. The S-Ab assay was evaluated for precision, linearity, interference (by hemoglobin, bilirubin, triglycerides, and biotin), cross-reactivity, and clinical performance, and was compared to the qualitative Elecsys anti-nucleocapsid (N-Ab) immunoassay, a lateral flow device that qualitatively detects S-Ab and N-Ab, and an anti-spike enzyme-linked immunosorbent assay (ELISA). Read More

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Lithium heparin interference in the Abbott enzymatic creatinine assay: the significance of under-filled tubes.

Ann Clin Biochem 2021 Aug 31:45632211040673. Epub 2021 Aug 31.

Department of Clinical Biochemistry, Airedale Hospital, 4215Airedale NHS Foundation Trust, Keighley, UK.

Background: Spuriously high results using the Abbott Architect enzymatic creatinine assay were noted to be particularly associated with very small sample volumes. This led us to query the effect of under-filling lithium heparin tubes on the measured enzymatic creatinine result.

Methods: Blood was provided by 5 laboratory personnel and then decanted into 5 x1. Read More

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Glycolic Acid Exacerbates the Analytical Performance of Lactate Assay.

Ann Clin Lab Sci 2021 Jul;51(4):584-586

Department of Pathology, The MetroHealth System, Cleveland, OH, USA

In this study, we evaluated the analytical interference of glycolic acid on several lactate assays that use lactate oxidase and dehydrogenase. Herein, we tested the effect of different concentrations of glycolic acid (0.01-46mM) on the lactate assay by using central lab and point of care (POCT) analyzers: Radiometer ABL 800, Beckman AU480, Roche Cobas c502, and Abbott i-STAT. Read More

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Reduced Relative Sensitivity of the Elecsys SARS-CoV-2 Antigen Assay in Saliva Compared to Nasopharyngeal Swabs.

Microorganisms 2021 Aug 10;9(8). Epub 2021 Aug 10.

Institute of Medical Virology, University of Zurich, 8057 Zurich, Switzerland.

Early identification and isolation of SARS-CoV-2-infected individuals is central to contain the COVID-19 pandemic. Nasopharyngeal swabs (NPS) serve as a specimen for detection by RT-PCR and rapid antigen screening tests. Saliva has been confirmed as a reliable alternative specimen for RT-PCR and has been shown to be valuable for diagnosing children and in repetitive mass testing due to its non-invasive collection. Read More

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Technical Evaluation of the COBAS EGFR Semiquantitative Index (SQI) for Plasma cfDNA Testing in NSCLC Patients with EGFR Exon 19 Deletions.

Diagnostics (Basel) 2021 Jul 22;11(8). Epub 2021 Jul 22.

Molecular Biology CORE, Hospital Clínic, 08036 Barcelona, Spain.

The cobas EGFR Test provides a semiquantitative index (SQI) that reflects the proportion of mutated versus wild-type copies of the gene in plasma. The significance of SQI as an indirect measure of the variant allele frequency (VAF) or mutated copies/mL remains unclear. The aim of this study was to evaluate the correlation of SQI with the VAF and the number of mutated copies/mL obtained by a digital droplet PCR (ddPCR) test in NSCLC samples. Read More

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Clinical Comparison of Three Sample-to-Answer Systems for Detecting SARS-CoV-2 in B.1.1.7 Lineage Emergence.

Infect Drug Resist 2021 17;14:3255-3261. Epub 2021 Aug 17.

Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.

Purpose: Accurate molecular diagnostic assays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, are needed for epidemiology studies and to support infection-control measures. We evaluated the analytical sensitivity and clinical performance of three sample-to-answer molecular-diagnostics systems for detecting SARS-CoV-2 using 325 nasopharyngeal swab clinical samples from symptomatic patients.

Methods: The BioFire Respiratory Panel 2. Read More

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HIV-1 diagnosis using dried blood spots from patients in Kinshasa (DRC): a tool to detect misdiagnosis and achieve WHO 2030 targets.

Int J Infect Dis 2021 Aug 19. Epub 2021 Aug 19.

Clínica Universidad de Navarra, Microbiology Department, Pamplona (Spain); ISTUN, Institute of Tropical Health Universidad de Navarra; IdiSNA, Navarra Institute for Health Research. Electronic address:

Introduction: Currently, only 54% of the population Democratic Republic of the Congo (DRC) know their HIV status. The aim of this study was to detect HIV misdiagnosis from Rapid Diagnostic Tests (RDT) and to evaluate serological immunoassays using Dried Blood Spots (DBS) from patients in Kinshasa, DRC.

Methods: Between 2016 and 2018, 365 DBS samples were collected from 363 individuals and were shipped to Spain, from people with a new HIV positive (n=123) or indeterminate (n=23) result, known HIV-positive patients (n=157) and a negative control group (n=62). Read More

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Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised controlled trial.

Authors:

Lancet Glob Health 2021 Oct 19;9(10):e1391-e1401. Epub 2021 Aug 19.

Background: Risk of mortality following surgery in patients across Africa is twice as high as the global average. Most of these deaths occur on hospital wards after the surgery itself. We aimed to assess whether enhanced postoperative surveillance of adult surgical patients at high risk of postoperative morbidity or mortality in Africa could reduce 30-day in-hospital mortality. Read More

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October 2021

Demonstrating the feasibility of accurately and reliably correcting potassium results for mildly hemolytic samples using a new experimental design.

Clin Chim Acta 2021 Aug 18;522:83-87. Epub 2021 Aug 18.

Department of Laboratory Medicine, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address:

Background And Aims: For several decades, there has been an ongoing debate about the appropriateness and reliability of correcting potassium concentration results for hemolyzed samples. As part of implementing a new Roche Cobas Pro analyzer system the possibility of correcting potassium results in hemolytic samples using a new, thorough experimental design, was investigated.

Materials And Methods: The relationship between hemolytic index (HI) and increases in potassium concentration was studied by performing a linear regression on hemolysate dilution series (HI 0-160 mg/dL) from 20 left-over patient samples. Read More

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Audit of laboratory sensitivity of human papillomavirus and cytology testing in a cervical screening program.

Int J Cancer 2021 Aug 21. Epub 2021 Aug 21.

Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.

The globally recommended public health policy for cervical screening is primary human papillomavirus (HPV) screening with cytology triaging of positives. To ensure optimal quality of laboratory services we have conducted regular audits of cervical smears taken before cervical cancer or cancer in situ (CIN3+) within an HPV-based screening program. The central cervical screening laboratory of Stockholm, Sweden, identified cases of CIN3+ who had had a previous cervical screening test up to 3 years before and randomly selected 300 cervical liquid-based cytology (LBC) samples for auditing. Read More

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Longitudinal evaluation of laboratory-based serological assays for SARS-CoV-2 antibody detection.

Pathology 2021 Jul 20. Epub 2021 Jul 20.

Department of Microbiology, Royal Melbourne Hospital at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia; The Peter Doherty Institute for Infection and Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Vic, Australia; Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, Vic, Australia.

Serological assays for SARS-CoV-2 infection are now widely available for use in diagnostic laboratories. Limited data are available on the performance characteristics in different settings, and at time periods remote from the initial infection. Validation of the Abbott (Architect SARS-CoV-2 IgG), DiaSorin (Liaison SARS-CoV-2 S1/S2 IgG) and Roche (Cobas Elecsys Anti-SARS-CoV-2) assays was undertaken utilising 217 serum samples from 131 participants up to 7 months following COVID-19 infection. Read More

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A new strategy for the computer-assisted development of reversed-phase liquid chromatography separation methods of unknown sample mixtures.

Anal Bioanal Chem 2021 Aug 18. Epub 2021 Aug 18.

Mestrelab Research S.L. Santiago de Compostela, Santiago, Spain.

A new strategy for the computer-assisted methods development in the reversed-phase liquid chromatographic separations of unknown sample mixtures has been developed using the latent spectral information in chromatogram raw data files of appropriately designed experiments, rather than resorting to elemental information functions (e.g., the number of peaks in chromatograms or similar criteria). Read More

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Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study.

Enferm Infecc Microbiol Clin 2021 Aug 14. Epub 2021 Aug 14.

Servicio de Microbiología, Hospital Universitario Ramón y Cajal. IRYCIS, Madrid, España; CIBER Epidemiología Salud Pública (CIBERESP), Madrid, España. Electronic address:

Introduction: The early detection of cervical cancer requires the implementation of molecular screening programs for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated. Read More

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Discrepancy between PCR based SARS-CoV-2 tests suggests the need to re-evaluate diagnostic assays.

BMC Res Notes 2021 Aug 17;14(1):316. Epub 2021 Aug 17.

Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, Pakistan.

Objective: We investigated the discrepancy between clinical and PCR-based diagnosis of COVID-19. We compared results of ten patients with mild to severe COVID-19. Respiratory samples from all cases were tested on the Roche SARS-CoV-2 (Cobas) assay, Filmarray RP2. Read More

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Evaluation of the Aptima HIV-1 Quant Dx assay for HIV diagnosis at birth in South Africa.

Diagn Microbiol Infect Dis 2021 Jun 29;101(3):115467. Epub 2021 Jun 29.

Centre for HIV and STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.

The increased coverage of antiretroviral therapy has resulted in a decrease in the positive predictive value (PPV) and diagnostic sensitivity of early infant diagnosis assays. To evaluate the diagnostic performance of the Aptima HIV-1 Quant DX assay (Aptima) in detecting HIV infection at birth. The study was a cross-sectional laboratory based evaluation using whole blood DBS specimens. Read More

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Determination of serum carbamazepine and its metabolite by validated tandem mass spectrometric method and the effect of carbamazepine on various hematological and biochemical parameters.

J Pharm Biomed Anal 2021 Aug 3;205:114299. Epub 2021 Aug 3.

Department of Biochemistry, Selcuk University Faculty of Medicine, Konya, Turkey.

Objectives: The study aimed to develop a validated LC-MS / MS method for the measurement of carbamazepine and carbamazepine-10,11-epoxide (CBZE) levels, to compare the carbamazepine concentrations measured by AbSciex API 3200 LC-MS/MS and Beckman Coulter Emit® 2000 immunoassay and to investigate the effect of carbamazepine concentrations on various hematological and biochemical parameters.

Methods: For the measurement of carbamazepine and CBZE levels, a validated LC-MS / MS method was developed. Serum carbamazepine levels of patients were measured by AbSciex API 3200 LC-MS / MS and Beckman Coulter Emit® 2000 immunoassay. Read More

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Alternative detection of SARS-CoV-2 RNA by a new assay based on mass spectrometry.

Clin Chem Lab Med 2021 Aug 12. Epub 2021 Aug 12.

Central Laboratory, Klinikum Wels-Grieskirchen GmbH, Wels, Austria.

Objectives: Accurate detection of SARS-CoV-2 RNA is essential to stopping the spread of SARS-CoV-2. The aim of this study was to evaluate the performance of the recently introduced MassARRAY SARS-CoV-2 Panel and to compare it to the cobas SARS-CoV-2 Test.

Methods: The MassARRAY SARS-CoV-2 Panel consists of five assays targeting different sequences of the SARS-CoV-2 genome. Read More

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Comparability of 11 different equations for estimating LDL cholesterol on different analysers.

Clin Chem Lab Med 2021 Aug 11. Epub 2021 Aug 11.

Department of Chemical Pathology, Faculty of Health Sciences, University of Pretoria and National Health Laboratory Service Tshwane Academic Division, Pretoria, South Africa.

Objectives: Low-density lipoprotein cholesterol (LDL-C) estimation is critical for risk classification, prevention and treatment of atherosclerotic cardiovascular disease (ASCVD). Predictive equations and direct LDL-C are used. We investigated the comparability between the Martin/Hopkins, Sampson, Friedewald and eight other predictive equations on two analysers, to determine whether the equation or analyser influences predicted LDL-C result. Read More

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Biotin as a masking agent in chorionic gonadotropin assays utilizing biotinylated antibodies.

Drug Test Anal 2021 Aug 10. Epub 2021 Aug 10.

UCLA Olympic Analytical Laboratory, Department of Pathology and Laboratory Medicine, David Geffen School of Medicine, Los Angeles, California, USA.

Biotin interference in streptavidin/biotin-based immunoassays has been recently recognized as a confounding factor in clinical settings. Depending on the nature of the assay, the presence of excess biotin in patient samples can cause falsely high or low results. One of the platforms known to be affected, Roche Cobas, is widely used in anti-doping laboratories to test for intact chorionic gonadotropin (hCG) in urine. Read More

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Multicenter Evaluation of a Fully Automated High-Throughput SARS-CoV-2 Antigen Immunoassay.

Infect Dis Ther 2021 Aug 9. Epub 2021 Aug 9.

Center for Diagnostics, Institute of Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Germany.

Introduction: Molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to suffer from delays and shortages. Antigen tests have recently emerged as a viable alternative to detect patients with high viral loads, associated with elevated risk of transmission. While rapid lateral flow tests greatly improved accessibility of SARS-CoV-2 detection in critical areas, their manual nature limits scalability and suitability for large-scale testing schemes. Read More

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The performance of Cobas HPV test for cervical cancer screening in Chinese female migrant workers.

Epidemiol Infect 2021 08 9;149:e196. Epub 2021 Aug 9.

Gynecologic Outpatient Department, Guangzhou Women and Children's Medical Center, Guangzhou510621, P.R. China.

This study aimed to evaluate the performance of Cobas human papillomavirus (HPV) test in cervical cancer screening. A total of 3442 women aged ⩾20 years used Cobas HPV and hybrid capture 2 (HC2) tests were included in this study. Women with any positive result were examined by liquid-based cytology (LBC) test. Read More

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