An Automated Clinical Laboratory Decision Support System for Test Utilization, Medical Necessity Verification and Payment Processing.

Physicians could improve the efficiency of the healthcare system if a reliable resource were available to aid them in better understanding, selecting, and interpreting the diagnostic laboratory tests. It has been well established and widely recognized that (a) laboratory testing provides 70-85% of the objective data that physicians use in diagnosis and treatment of their patients, (b) orders for laboratory tests in the U.S.

EarlyTect BCD, a Streamlined PENK Methylation Test in Urine DNA, Effectively Detects Bladder Cancer in Patients with Hematuria.

The current noninvasive diagnostic approaches for detecting bladder cancer (BC) often exhibit limited clinical performance, especially for the initial diagnosis. This study aims to evaluate the validity of a streamlined urine-based PENK methylation test called EarlyTect BCD in detecting BC in patients with hematuria scheduled for cystoscopy in Korean and American populations. The test seamlessly integrates two steps, linear target enrichment and quantitative methylation-specific PCR within a single closed tube.

Functional status and quality of life in post-COVID-19 patients two to three weeks after hospitalization: A cross-sectional study.

Background And Aims: Extended hospitalization due to coronavirus disease 2019 (COVID-19) is associated with residual musculoskeletal and functional deficits lasting even 6 months after discharge; therefore, it is crucial that post-hospitalized patients are promptly assessed. The aim of this study was to identify post-COVID-19 patients' functional status and quality of life, as well as to investigate their inter-relatedness 2-3 weeks after hospital discharge.

Methods: The study included 39 post-COVID-19 patients previously hospitalized in the Clinic for Infectious Diseases at the University Clinical Center of Kosovo (UCCK) from August to December 2021.

Effects of Physiotherapy on Rehabilitation and Quality of Life in Patients Hospitalized for COVID-19: A Review of Findings from Key Studies Published 2020-2022.

The estimated percentage of individuals with COVID-19 due to infection with SARS-CoV-2 in need of hospitalization mostly increases proportionally with age, reaching almost 10% for those older than 60 years. Among hospitalized patients, one-fifth require treatment in the intensive care unit (ICU) due to acute respiratory distress syndrome, multiorgan failure, or hypoxemic respiratory insufficiency. Patients with moderate and severe COVID-19 who were hospitalized during the early stages of the pandemic and who continue to be hospitalized report fatigue, muscle weakness, joint stiffness, reduced mobility, increased risk of falls, and impaired quality of life.

Performance Evaluation of TaqMan SARS-CoV-2, Flu A/B, RSV RT-PCR Multiplex Assay for the Detection of Respiratory Viruses.

Purpose: To detect and differentiate co-infection with influenza and respiratory syncytial virus during the COVID pandemic, a rapid method that can detect multiple pathogens in a single test is a significant diagnostic advance to analyze the outcomes and clinical implications of co-infection. Therefore, we validated and evaluated the performance characteristics of TaqMan SARS-CoV-2, Flu A/B, RSV RT-PCR multiplex assay for the detection of SARS-CoV-2, Flu A/B, and RSV using nasopharyngeal and saliva samples.

Materials And Methods: The method validation was performed by using culture fluids of Influenza A virus (H3N2) (A/Wisconsin/67/2005), Influenza B virus (B/Virginia/ATCC4/2009), RSV A2 cpts-248, SARS-CoV-2 (USA-WA1/2020) and quantitative RNA controls of Influenza A virus (H1N1) strain A/PR/8/34 (VR-95DQ), RSV A2 (VR-1540DQ) and SARS-CoV-2 (MN908947.

SARS-CoV-2 Variants Detection Using TaqMan SARS-CoV-2 Mutation Panel Molecular Genotyping Assays.

Purpose: For rapid detection and tracking of SARS-CoV-2, a simple screening method alternative to laborious and expensive sequencing is highly desirable. Here, we evaluated performance characteristics of TaqMan SARS-CoV-2 mutation panel genotyping molecular assay for detection of most common reported SARS-CoV-2 variants using specific RT-PCR assays targeting single nucleotide polymorphisms (SNP).

Patients And Methods: A total of 150 SARS-CoV-2 positive samples from March to July were included for this study.

Evaluation of Analytical Performance of Seven Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus.

Background: Early diagnosis of the novel coronavirus disease of 2019 (COVID-19) in asymptomatic and symptomatic patients is crucial to identify infectious individuals and to help prevent the spread of the virus in the community. Several assays have been developed and are in use in today's clinical practice. These assays vary in their analytical and clinical performance.

Validation of an mRNA-based Urine Test for the Detection of Bladder Cancer in Patients with Haematuria.

Background: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer Detection (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC.

Objective: To validate the performance of Xpert in patients with haematuria.

Outcome of 24 Weeks of Combined Schroth and Pilates Exercises on Cobb Angle, Angle of Trunk Rotation, Chest Expansion, Flexibility and Quality of Life in Adolescents with Idiopathic Scoliosis.

BACKGROUND This study aimed to quantify the outcomes of combining Schroth and Pilates exercises on the Cobb angle, angle of trunk rotation (ATR), chest expansion, flexibility (trunk flexion), and quality of life (QoL) in adolescents with mild and moderate idiopathic scoliosis. MATERIAL AND METHODS Sixty-nine adolescents with idiopathic scoliosis aged 10-17 years, presenting with a Cobb angle of 10-45º were enrolled in this study. The treatment protocol, including selected exercises from Schroth and Pilates methods, was performed over 24 weeks and consisted of 2 periods of 2-week treatment regimens performed daily for 60 minutes.

Concordance of Fingerstick and Venipuncture Sampling for Fertility Hormones.

Background: Minimally invasive fingerstick sampling allows testing of reproductive hormone levels at home, providing women with increased access to tests that can screen for conditions such as polycystic ovarian syndrome, primary ovarian insufficiency, and pituitary and thyroid dysfunction.

Method: We present a measurement procedure comparison study of matched venipuncture and fingerstick samples from 130 women aged 18-40 years, tested on menstrual cycle day 3. Samples were measured for anti-müllerian hormone, estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), testosterone, thyroid-stimulating hormone (TSH), and free thyroxine (T4) levels.

Prospective Validation of an mRNA-based Urine Test for Surveillance of Patients with Bladder Cancer.

Background: A fast, noninvasive test with high sensitivity (SN) and a negative predictive value (NPV), which is able to detect recurrences in bladder cancer (BC) patients, is needed. A newly developed urine assay, Xpert Bladder Cancer Monitor (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC.

Objective: To validate Xpert characteristics in patients previously diagnosed with non-muscle-invasive BC.

Contribution of Physical and Motor Characteristics to Functional Performance in Children and Adolescents with Down Syndrome: A Preliminary Study.

BACKGROUND Down syndrome (DS) is the most frequent genetic mental disability. Individuals with DS experience a variety of physical, motor, and functional challenges throughout the lifespan. However, the inter-relatedness between these domains is relatively unexplored in children with DS.

Attainment of gross motor milestones in children with Down syndrome in Kosovo - developmental perspective.

Aim To investigate the age (in months) at which motor skills are developed in children with Down syndrome (DS), and compare it to the age of the development of the same skills in both, children with typical development (TD), and children with DS reported by four other studies. Methods Sixteen children (7 girls and 9 boys) were monthly assessed for the development of nineteen motor skills between 2008 and 2011. The mean ages when the skills were accomplished were presented using descriptive statistics.

Clinical Validation of a Test for the Diagnosis of Vaginitis.

Objective: Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians.

Antibody to Epstein-Barr virus deoxyuridine triphosphate nucleotidohydrolase and deoxyribonucleotide polymerase in a chronic fatigue syndrome subset.

Background: A defined diagnostic panel differentiated patients who had been diagnosed with chronic fatigue syndrome (CFS), based upon Fukuda/Carruthers criteria. This diagnostic panel identified an Epstein-Barr virus (EBV) subset of patients (6), excluding for the first time other similar "clinical" conditions such as cytomegalovirus (CMV), human herpesvirus 6 (HHV6), babesiosis, ehrlichiosis, borreliosis, Mycoplasma pneumoniae, Chlamydia pneumoniae, and adult rheumatic fever, which may be mistakenly called CFS. CFS patients were treated with valacyclovir (14.

Multicenter evaluation of the BD Max GBS assay for detection of group B streptococci in prenatal vaginal and rectal screening swab specimens from pregnant women.

A new integrated extraction and real-time PCR-based system for the detection of group B streptococci in antepartum screening samples enriched in Lim broth was compared to the CDC-recommended culture method. The BD Max GBS assay exhibited acceptable sensitivity (95%) and specificity (96.7%) compared to those of the culture method in this multisite evaluation.

Validation of the energy index point score to serially measure the degree of disability in patients with chronic fatigue syndrome.

Background: A simple quantitative accurate method for assessing the degree of fatigue in patients with chronic fatigue syndrome (CFS) is necessary for physicians and patients. Severity of the disease and recovery can, thus, be assayed.

Patient And Methods: From February 1-27, 2007, fifty-six consecutive CFS patients at a single treatment center were simultaneously evaluated by the patient with the fatigue severity score (FSS), and by consensus of both patient and physician by the energy index (EI) point score.

Immunoassay with cytomegalovirus early antigens from gene products p52 and CM2 (UL44 and UL57) detects active infection in patients with chronic fatigue syndrome.

Aims: To investigate whether the use of recombinant early antigens for detection of antibodies to human cytomegalovirus (HCMV) gene products CM(2) (UL44, UL57) and p52 (UL44) is specific in the diagnosis and differentiation of active HCMV infection in a subset of patients with chronic fatigue syndrome (CFS), a diagnosis which is often missed by the current ELISA assay that uses crude viral lysate antigen.

Methods: At a single clinic from 1999 to 2001, a total of 4774 serological tests were performed in 1135 patients with patients using two immunoassays, Copalis and ELISA. The Copalis immunoassay utilised HCMV early gene products of UL44 and UL57 recombinant antigens for detection of HCMV IgM antibody, and viral capsid antigen for detection of HCMV IgG antibody.

Valacyclovir treatment in Epstein-Barr virus subset chronic fatigue syndrome: thirty-six months follow-up.

We hypothesized that subset classification of Epstein-Barr virus (EBV) in chronic fatigue syndrome (CFS) is required. At first, a blinded-random placebo-controlled trial of valacyclovir in EBV CFS subset was performed (Group 1), and this EBV subset was followed for thirty-six months (Group 2). Patients were given valacyclovir at 14.

Use of the real-time PCR assay in conjunction with MagNA Pure for the detection of mycobacterial DNA from fixed specimens.

Tuberculosis in immunocompromised patients is often caused by Mycobacterial species other than Mycobacterium tuberculosis. Thus, detection of and differentiation between M. tuberculosis and nontuberculosis species is necessary for diagnosis of disease in these patients.

Evaluation of a Digene-recommended algorithm for human papillomavirus low-positive results present in a "retest zone".

The Digene Hybrid Capture 2 (hc2) high-risk human papillomavirus (HPV) DNA test (Digene, Gaithersburg, MD) is widely used for triage of women with atypical squamous cells of undetermined significance. Results in a "retest zone" (weakly positive tests) are repeated up to 2 times according to the Digene-recommended algorithm. We studied 56 cervical samples in the retest zone.

Role of basic fibroblast growth factor in the neuropathic bladder phenotype.

Purpose: The neuropathic bladder is characterized by increased muscle mass within the bladder wall and reduced functional capability. The exact cellular mechanisms that regulate these changes have yet to be elucidated. We determine the role of basic fibroblast growth factor (bFGF) in the increased smooth muscle cell (SMC) proliferation seen in the neuropathic bladder.

Prevalence of abnormal cardiac wall motion in the cardiomyopathy associated with incomplete multiplication of Epstein-barr Virus and/or cytomegalovirus in patients with chronic fatigue syndrome.

We reported unique incomplete herpesvirus (Epstein-Barr Virus (EBV) and/or nonstructural (HCMV) cytomegalovirus) multiplication in 2 distinct subsets of CFS patients. The CFS subsets were identified by: a) presence of IgM serum antibodies to HCMV nonstructural gene products p52 and CM2 (UL44 and UL57), and/or b) IgM serum antibodies to Epstein-Barr virus viral capsid antigen (EBV, VCA IgM). Diagnostic IgM serum antibodies were found in two independent blinded studies involving 49 CFS patients, but the same antibodies were absent in 170 control patients (p<0.