This new Advisory Document replaces the 1995 consensus document on the Application of the Principles of GLP to Computerised Systems. It retains all of the key text from the original 1995 document, but includes new text to reflect the current state-of-the art in this field.

GLP issues raised by testing labs are covered in this comprehensive list of questions and answers, recently updated with questions related to: sponsors, Contract Research Organisations (CROs), sub-contractors, archives, Information Technology (IT), Biotechnology/GMOs and other miscellaneous issues

The purpose of this document is to give guidance to Receiving Authorities on the evaluation of the GLP compliance status of nonclinical safety studies submitted for regulatory purposes. This guidance does not address the scientific evaluation and interpretation of the submitted data or the risk assessment based on these data.

Archives, Room Use Only - TK411.S53 1905

Beamline 8A (BL 8A) is an undulator-based soft X-ray beamline at Pohang Accelerator Laboratory. This beamline is aimed at high-resolution ambient-pressure X-ray photoelectron spectroscopy (AP-XPS), soft X-ray absorption spectroscopy (soft-XAS) and scanning photoemission microscopy (SPEM) experiments. BL 8A has two branches, 8A1 SPEM and 8A2 AP-XPS, that share a plane undulator, the first mirror (M1) and the monochromator. The photon beam is switched between the two branches by changing the refocusing mirrors after the monochromator. The acceptance angle of M1 is kept glancing at 1.2°, and Pt is coated onto the mirrors to achieve high reflectance, which ensures a wide photon energy range (100–2000 eV) with high resolution at a photon flux of ∼1013 photons s−1. In this article, the main properties and performance of the beamline are reported, together with selected experiments performed on the new beamline and experimental system.

MAX IV is a fourth-generation, or diffraction-limited, synchrotron light source with a number of state-of-the-art beamlines. The performance of a beamline is, to a high degree, set by the energy resolution it can achieve, which in turn is governed to a large extent by the monochromator. During the design phase of a monochromator, the mechanical requirements must be fully understood and met with margin. During commissioning, the performance must be verified and optimized. In this paper, six soft X-ray monochromators at MAX IV beamlines (Bloch, Veritas, HIPPIE, SPECIES, FinEstBeAMS and SoftiMAX) are examined with a focus on their resolving power, energy range and the time required to change measurement range, as those parameters are dependent on each other. The monochromators have a modern commercial design, planned and developed in close collaboration with the vendors. This paper aims to present the current status of the commissioning at MAX IV with emphasis on elucidating the mechanical limitations on the performance of the monochromators. It contains analysis of the outcome and our approach to achieve fast and high-resolution monochromators.

A method for reconstructing the three-dimensional grain structure from data collected with a recently introduced laboratory-based X-ray diffraction contrast tomography system is presented. Diffraction contrast patterns are recorded in Laue-focusing geometry. The diffraction geometry exposes shape information within recorded diffraction spots. In order to yield the three-dimensional crystallographic microstructure, diffraction spots are extracted and fed into a reconstruction scheme. The scheme successively traverses and refines solution space until a reasonable reconstruction is reached. This unique reconstruction approach produces results efficiently and fast for well suited samples.

Birds do it. Bees do it. And in a laboratory in northern California, scientists using bumblebees recently figured out the best way to measure it--vertical lift!

The post Laboratory tests reveal precise way to measure vertical lift in bumblebees and other small insects and birds appeared first on Smithsonian Insider.

During a press conference Friday, July 22 at the Smithsonian's National Air and Space Museum, NASA announced that Gale Crater will be the landing site for the Mars Science Laboratory. Scheduled to launch in late 2011 and arrive at Mars in August 2012, the Mars Science Laboratory is a rover that will assess the planet’s “habitability”—if it ever was, or is today, an environment able to support microbial life.

The post Gale Crater to be landing site for NASA’s Mars Science Laboratory appeared first on Smithsonian Insider.

Researchers at the Smithsonian's National Zoo's new genetics lab use animal DNA to diagnose new diseases, discover new species help in conservation efforts and solve mysteries.

The post Scientists at a new National Zoo laboratory use DNA to diagnose illnesses and discover new species of animals appeared first on Smithsonian Insider.

A new rapid expert consultation from a standing committee of the National Academies of Sciences, Engineering, and Medicine.

Constructed wetlands can effectively remove veterinary drugs from wastewater, preventing contamination of the environment, research suggests. A recent study has demonstrated that laboratory-scale constructed wetlands were able to remove between 94 and 98% of two commonly used antibiotics from pig farm wastewater.

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NTU Singapore, the Singapore National Eye Centre (SNEC), and the Singapore Eye Research Institute (SERI) have launched a joint laboratory that will develop advanced eye imaging technologies and drug delivery systems....

These robotic labs, called ESPs, collect water samples in the open water and can determine if a beach is safe for swimming or water is clean enough to drink

The tenth SpaceX cargo resupply launch to the International Space Station, targeted for launch Feb. 18, will deliver investigations that study human health, Earth science and weather patterns.

How a dental laboratory is stepping up in the fight against COVID-19

Genomes - an organism's complete set of DNA, including all of its genes - of any two people are more than 99 per cent the same. Reference laboratory to be created by Pure Health in Middle East.

As part of its mission to support treatment of currently incurable diseases in communities, the Bedford Research Foundation clinical laboratory, located in Massachusetts, will begin offering a highly sensitive highly specific test for SARS-2.

Pure Health Proves the Value of Public Private Partnership.

Labcon Advances Industry Leading Commitment to Environmental Responsibility with Addition of ACT Environmental Impact Factor Label on More Than 100 Products.

Daubert Cromwell, a leading manufacturer of corrosion inhibitor (VCI) products for metalworking industries, announces that its Testing Laboratory has attained ISO/IEC 17025:2017 accreditation.

This PCB maker is capable of printing/manufacturing any circuit board fed through a computer software.

The present invention relates to an apparatus for mixing and controlling the temperature of laboratory vessel contents with an accommodating device in detachable connection with an exchangeable block for accommodating and controlling the temperature of laboratory vessels and with a drive by which the accommodating device can be set in a mixing motion, and with a temperature control device with a heat source or sink in heat-conducting connection with the exchangeable block at least through in each case at least one adjoining contact face firstly on the accommodating device and secondly on the exchangeable block, which is characterized in that the detachable connection is maintained by a spring element which, by virtue of its spring force, horizontally clamps together a first undercut between the accommodating device and the exchangeable block in at least one first direction.

Compositions and methods useful for point of care testing for hemophilia by measuring coagulation factor levels are provided.

Sometimes you need to experiment to grow as an artist. What better place to try out new design ideas than the Drawing Vector Graphics Laboratory? Every Wednesday, Von Glitschka introduces a new method, tool, or resource to stretch your creative muscle and explore a new artistic style. Each lesson pulls back the curtain on Von's design process—the good, the bad, and the ugly—to give beginners the self-confidence they need to start drawing and provide experts an inside look at a fellow professional's workflow.

Note: Because this is an ongoing series, viewers will not receive a certificate of completion.

Crucial cattle herd genetics have been lost in a fire that destroyed 100 cryogenic cylinders of cattle semen in south-east Victoria overnight.

(United States Second Circuit) - Judgment dismissing this qui tam action alleging that defendants engaged in a scheme of kickbacks, bribes, or rebates designed to induce referrals of Medicare and Medicaid business, is affirmed, where: 1) defendant's former general counsel, through his conduct in this qui tam action, violated his ethical obligations under New York Rules of Professional Conduct 1.9(c) which, in relevant part, prohibits lawyers from using confidential information of a former client protected by Rule 1.6 to the disadvantage of the former client, except to the extent that the lawyer reasonably believes necessary to prevent the client from committing a crime; and 2) the district court did not err by dismissing the complaint as to all defendants, and disqualifying plaintiff, its general partners, and its outside counsel on the basis that such measures were necessary to avoid prejudicing defendants in any subsequent litigation on these facts.

(California Court of Appeal) - Judgment for plaintiff finding that defendant had misappropriated plaintiff's trade secrets regarding its digital stamping technology (DST), which was disclosed to defendant during negotiations pursuant to Non-Disclosure Agreement, is affirmed, where: 1) plaintiff did not fail to adequately identify its trade secrets; 2) the trial court did not err in its identification of the misappropriated trade secrets; 3) ideas are protectable as trade secrets; 4) design concepts underlying plaintiff's DST constitute protectable "information"; 5) substantial evidence supports the trial court's finding that plaintiff's DST design concepts had independent economic value and the finding that defendant misappropriated plaintiff's trade secrets; 6) the trial court properly based its damages award on the reasonable royalty measure of damages, and did not err in awarding prejudgment interest; and 7) defendant has not demonstrated the trial court abused its discretion in basing its fee award on local hourly rates or shown the hourly rates employed by the trial court were unreasonable.

(University of Bath) For the first time, labs around the world can 3D print their own precision microscopes, thanks to an open-source design created at Bath.

With their state’s caucuses the first official marker in the 2020 presidential contest, Iowa teenagers are in a unique position to observe and participate.

Agency: HSS Closing Date: 6/12/2020

The Philippines’ Department of Health (DOH), with support from ADB, has set up a new laboratory in Pampanga province, north of the capital Manila. It will significantly increase the government’s testing capacity for COVID-19...

The Philippines’ Department of Health (DOH), with support from ADB, has set up a new laboratory in Pampanga province, north of the capital Manila. It will significantly increase the government’s testing capacity for COVID-19...

The presence of antinuclear antibodies (ANAs) is a hallmark of a number of systemic autoimmune rheumatic diseases, and testing is usually performed as part of the initial diagnostic workup when suspicion of an underlying autoimmune disorder is high. The indirect immunofluorescence antibody (IFA) technique is the preferred method for detecting ANAs, as it demonstrates binding to specific intracellular structures within the cells, resulting in a number of staining patterns that are usually categorized based on the cellular components recognized and the degree of binding, as reflected by the fluorescence intensity or titer. As a screening tool, the ANA patterns can guide confirmatory testing useful in elucidating a specific clinical diagnosis or prognosis. However, routine use of ANA IFA testing as a global screening test is hampered by its labor-intensiveness, subjectivity, and limited diagnostic specificity, among other factors. This review focuses on current efforts to standardize the nomenclature of ANA patterns and on alternative methods for ANA determination, as well as on recent advances in image-based computer algorithms to automate IFA testing in clinical laboratories.

Current pneumococcal vaccines cover the 10 to 23 most common serotypes of the 92 presently described. However, with the increased usage of pneumococcal-serotype-based vaccines, the risk of serotype replacement and an increase in disease caused by nonvaccine serotypes remains. Serotype surveillance of pneumococcal infections relies heavily on culture techniques, which are known to be insensitive, particularly in cases of noninvasive disease. Pneumococcal-serotype-specific urine assays offer an alternative method of serotyping for both invasive and noninvasive disease. However, the assays described previously cover mainly conjugate vaccine serotypes, give little information about circulating nonvaccine serotypes, and are currently available only in one or two specialist laboratories. Our laboratory has developed a Luminex-based extended-range antigen capture assay to detect pneumococcal-serotype-specific antigens in urine samples. The assay targets 24 distinct serotypes/serogroups plus the cell wall polysaccharide (CWP) and some cross-reactive serotypes. We report that the assay is capable of detecting all the targeted serotypes and the CWP at 0.1 ng/ml, while some serotypes are detected at concentrations as low as 0.3 pg/ml. The analytical serotype specificity was determined to be 98.4% using a panel of polysaccharide-negative urine specimens spiked with nonpneumococcal bacterial antigens. We also report clinical sensitivities of 96.2% and specificities of 89.9% established using a panel of urine specimens from patients diagnosed with community-acquired pneumonia or pneumococcal disease. This assay can be extended for testing other clinical samples and has the potential to greatly improve serotype-specific surveillance in the many cases of pneumococcal disease in which a culture is never obtained.

Bovine tuberculosis (TB), caused by Mycobacterium bovis, remains an important zoonotic disease posing a serious threat to livestock and wildlife. The current TB tests relying on cell-mediated and humoral immune responses in cattle have performance limitations. To identify new serodiagnostic markers of bovine TB, we screened a panel of 101 recombinant proteins, including 10 polyepitope fusions, by a multiantigen print immunoassay (MAPIA) with well-characterized serum samples serially collected from cattle with experimental or naturally acquired M. bovis infection. A novel set of 12 seroreactive antigens was established. Evaluation of selected proteins in the dual-path platform (DPP) assay showed that the highest diagnostic accuracy (~95%) was achieved with a cocktail of five best-performing antigens, thus demonstrating the potential for development of an improved and more practical serodiagnostic test for bovine TB.

Neutralizing antibodies specific for respiratory syncytial virus (RSV) represent a major protective mechanism against RSV infection, as demonstrated by the efficacy of the immune-prophylactic monoclonal antibody palivizumab in preventing RSV-associated lower respiratory tract infections in premature infants. Accordingly, the RSV neutralization assay has become a key functional method to assess the neutralizing activity of serum antibodies in preclinical animal models, epidemiology studies, and clinical trials. In this study, we qualified a 24-h, fluorescent focus-based microneutralization (RSVA FFA-MN) method that requires no medium exchange or pre- or postinfection processing to detect green fluorescent protein-expressing RSV strain A2 (RSVA-GFP)-infected cells, using a high-content imaging system for automated image acquisition and focus enumeration. The RSVA FFA-MN method was shown to be sensitive, with a limit of detection (LOD) and limit of quantitation (LOQ) of 1:10, or 3.32 log₂; linear over a range of 4.27 to 9.65 log₂ 50% inhibitory concentration (IC₅₀); and precise, with intra- and interassay coefficients of variation of <21%. This precision allowed the choice of a statistically justified 3-fold-rise seroresponse cutoff criterion. The repeatability and robustness of this method were demonstrated by including a pooled human serum sample in every assay as a positive control (PC). Over 3 years of testing between two laboratories, this PC generated data falling within 2.5 standard deviations of the mean 98.7% of the time (n = 1,720). This high-throughput and reliable RSV microneutralization assay has proven useful for testing sera from preclinical vaccine candidate evaluation studies, epidemiology studies, and both pediatric and adult vaccine clinical trials.

The number of onsite clinical microbiology laboratories in hospitals is decreasing, likely related to the business model for laboratory consolidation and labor shortages, and this impacts a variety of clinical practices, including that of banking isolates for clinical or epidemiologic purposes. To determine the impact of these trends, infectious disease (ID) physicians were surveyed regarding their perceptions of offsite services. Clinical microbiology practices for retention of clinical isolates for future use were also determined. Surveys were sent to members of the Infectious Diseases Society of America’s (IDSA) Emerging Infections Network (EIN). The EIN is a sentinel network of ID physicians who care for adult and/or pediatric patients in North America and who are members of IDSA. The response rate was 763 (45%) of 1,680 potential respondents. Five hundred forty (81%) respondents reported interacting with the clinical microbiology laboratory. Eighty-six percent of respondents thought an onsite laboratory very important for timely diagnostic reporting and ongoing communication with the clinical microbiologist. Thirty-five percent practiced in institutions where the core microbiology laboratory has been moved offsite, and an additional 7% (n = 38) reported that movement of core laboratory functions offsite was being considered. The respondents reported that only 24% of laboratories banked all isolates, with the majority saving isolates for less than 30 days. Based on these results, the trend toward centralized core laboratories negatively impacts the practice of ID physicians, potentially delays effective implementation of prompt and targeted care for patients with serious infections, and similarly adversely impacts infection control epidemiologic investigations.

This minireview focuses on the microbiologic evaluation of patients with asymptomatic bacteriuria, as well as indications for antibiotic treatment. Asymptomatic bacteriuria is defined as two consecutive voided specimens (preferably within 2 weeks) with the same bacterial species, isolated in quantitative counts of ≥10⁵ CFU/ml in women, including pregnant women; a single voided urine specimen with one bacterial species isolated in a quantitative count ≥10⁵ CFU/ml in men; and a single catheterized urine specimen with one or more bacterial species isolated in a quantitative count of ≥10⁵ CFU/ml in either women or men (or ≥10² CFU/ml of a single bacterial species from a single catheterized urine specimen). Any urine specimen with ≥10⁴ CFU/ml group B Streptococcus is significant for asymptomatic bacteriuria in a pregnant woman. Asymptomatic bacteriuria occurs, irrespective of pyuria, in the absence of signs or symptoms of a urinary tract infection. The two groups with the best evidence of adverse outcomes in the setting of untreated asymptomatic bacteriuria include pregnant women and patients who undergo urologic procedures with risk of mucosal injury. Screening and treatment of asymptomatic bacteriuria is not recommended in the following patient populations: pediatric patients, healthy nonpregnant women, older patients in the inpatient or outpatient setting, diabetic patients, patients with an indwelling urethral catheter, patients with impaired voiding following spinal cord injury, patients undergoing nonurologic surgeries, and nonrenal solid-organ transplant recipients. Renal transplant recipients beyond 1 month posttransplant should not undergo screening and treatment for asymptomatic bacteriuria. There is insufficient evidence to recommend for or against screening of renal transplant recipients within 1 month, patients with high-risk neutropenia, or patients with indwelling catheters at the time of catheter removal. Unwarranted antibiotics place patients at increased risk of adverse effects (including Clostridioides difficile diarrhea) and contribute to antibiotic resistance. Methods to reduce unnecessary screening for and treatment of asymptomatic bacteriuria aid in antibiotic stewardship.

BACKGROUND:

Prescribing of levothyroxine and rates of thyroid function testing may be sensitive to minor changes in the upper limit of the reference range for thyroid-stimulating hormone (TSH) that increase the proportion of abnormal results. We evaluated the population-level change in levothyroxine prescribing and TSH testing after a minor planned decrease in the upper limit of the reference range for TSH in a large urban centre with a single medical laboratory.

Secretary of State Mike Pompeo has claimed that the US has "a significant amount of evidence" that the new coronavirus emerged from a Chinese laboratory.

There are "questions to be asked" about where coronavirus came from, Boris Johnson's spokesperson has said.

The United States filed a complaint against BestCare Laboratories, Inc. and its founder and principal, Karim A. Maghareh, in the U.S. District Court for the Southern District of Texas.