scholarly journals COVID-19 Testing and Diagnostics: A Review of Commercialized Technologies for Cost, Convenience and Quality of Tests

Sensors ◽  
2021 ◽  
Vol 21 (19) ◽  
pp. 6581
Author(s):  
Ashler Benda ◽  
Lukas Zerajic ◽  
Ankita Ankita ◽  
Erin Cleary ◽  
Yunsoo Park ◽  
...  
Keyword(s):  
Universal Access ◽  
Screening Programs ◽  
Pooled Testing ◽  
Supply Chain Logistics ◽  
Molecular Tests ◽  
Specimen Collection ◽  
Near Term ◽  
Antigen Tests ◽  
The Masses

Population-scale and rapid testing for SARS-CoV-2 continues to be a priority for several parts of the world. We revisit the in vitro technology platforms for COVID-19 testing and diagnostics—molecular tests and rapid antigen tests, serology or antibody tests, and tests for the management of COVID-19 patients. Within each category of tests, we review the commercialized testing platforms, their analyzing systems, specimen collection protocols, testing methodologies, supply chain logistics, and related attributes. Our discussion is essentially focused on test products that have been granted emergency use authorization by the FDA to detect and diagnose COVID-19 infections. Different strategies for scaled-up and faster screening are covered here, such as pooled testing, screening programs, and surveillance testing. The near-term challenges lie in detecting subtle infectivity profiles, mapping the transmission dynamics of new variants, lowering the cost for testing, training a large healthcare workforce, and providing test kits for the masses. Through this review, we try to understand the feasibility of universal access to COVID-19 testing and diagnostics in the near future while being cognizant of the implicit tradeoffs during the development and distribution cycles of new testing platforms.

scholarly journals Lessons learned from implementation of SARS-CoV-2 screening in K-12 public schools in Massachusetts

2021 ◽  
Author(s):  
Andrea Ciaranello ◽  
Cathryn Goehringer ◽  
Sandra B Nelson ◽  
Liz J Ruark ◽  
Nira R Pollock
Keyword(s):  
Public Schools ◽  
Screening Program ◽  
Lessons Learned ◽  
Mitigation Measures ◽  
School Students ◽  
Screening Programs ◽  
Pooled Testing ◽  
Specimen Collection ◽  
Household Members ◽  
K 12

Abstract In-person learning provides substantial benefits for K-12 school students. Risk of SARS-CoV-2 infection among educators, staff, students, and household members can be markedly reduced by mitigation measures including masking, ventilation, and hygiene. In addition to these measures, regular SARS-CoV-2 screening testing is recommended by recent CDC guidance and supported financially by ongoing CDC and HHS initiatives for K-12 schools. Screening provides an added layer of risk reduction, as well as data and reassurance about in-school transmission. Financial and logistical constraints have challenged implementation of screening in public schools. We report lessons learned from a collaborative of public K-12 schools implementing and evaluating screening programs, including details of population screened, site of specimen collection, assay selection, pooled testing, and resources needed. This work supported the development of a state-wide screening program and led to dissemination of online technical resources that may support other public schools in implementing CDC guidance.

scholarly journals Performance of Unobserved Self-Collected Nasal Swabs for Detection of SARS-CoV-2 by RT-PCR Utilizing a Remote Specimen Collection Strategy

2021 ◽  
Author(s):  
Ron M Kagan ◽  
Amy A Rogers ◽  
Gwynngelle A Borillo ◽  
Nigel J Clarke ◽  
Elizabeth M Marlowe
Keyword(s):  
Return To Work ◽  
Screening Program ◽  
False Negative ◽  
N Gene ◽  
Rt Pcr ◽  
Pooled Testing ◽  
Specimen Collection ◽  
Asymptomatic Patients ◽  
Nasal Swabs ◽  
The Impact

Abstract Background The use of a remote specimen collection strategy employing a kit designed for unobserved self-collection for SARS-CoV-2 RT-PCR can decrease the use of PPE and exposure risk. To assess the impact of unobserved specimen self-collection on test performance, we examined results from a SARS-CoV-2 qualitative RT-PCR test for self-collected specimens from participants in a return-to-work screening program and assessed the impact of a pooled testing strategy in this cohort. Methods Self-collected anterior nasal swabs from employee return to work programs were tested using the Quest Diagnostics SARS-CoV-2 RT-PCR EUA. The Ct values for the N1 and N3 N-gene targets and a human RNase P (RP) gene control target were tabulated. For comparison, we utilized Ct values from a cohort of HCP-collected specimens from patients with and without COVID-19 symptoms. Results Among 47,923 participants, 1.8% were positive. RP failed to amplify for 13/115,435 (0.011%) specimens. The median (IQR) Cts were 32.7 (25.0-35.7) for N1 and 31.3 (23.8-34.2) for N3. Median Ct values in the self-collected cohort were significantly higher than those of symptomatic, but not asymptomatic patients. Based on Ct values, pooled testing with 4 specimens would have yielded inconclusive results in 67/1,268 (5.2%) specimens but only a single false-negative result. Conclusions Unobserved self-collection of nasal swabs provides adequate sampling for SARS-CoV-2 RT-PCR testing. These findings alleviate concerns of increased false negatives in this context. Specimen pooling could be used for this population as the likelihood of false negative results is very low due when using a sensitive, dual-target methodology.

High Rate of Negative Results of Tuberculin and QuantiFERON Tests Among Individuals With a History of Positive Skin Test Results

2006 ◽  
Vol 27 (5) ◽  
pp. 436-441 ◽  
Author(s):  
Lloyd N. Friedman ◽  
Esther R. Nash ◽  
June Bryant ◽  
Susan Henry ◽  
Julia Shi ◽  
...  
Keyword(s):  
Skin Test ◽  
Significant Proportion ◽  
High Rate ◽  
Negative Group ◽  
Tuberculosis Screening ◽  
Positive Skin ◽  
Screening Programs ◽  
History Of ◽  
Positive Results

Objectives.To evaluate individuals at high risk for tuberculosis exposure who had a history of a positive tuberculin skin test (TST) result in order to determine the prevalence of unsuspected negative TST results. To confirm these findings with the QuantiFERON-TB test (QFT), an in vitro whole-blood assay that measures tuberculin-induced secretion of interferon-γ.Methods.This survey was conducted from November 2001 through December 2003 at 3 sites where TST screening is regularly done. Detailed histories and reviews of medical records were performed. TSTs were placed and read by 2 experienced healthcare workers, and blood was drawn for QFT. Any subject with a negative result of an initial TST during the study (induration diameter, <10 mm) underwent a second TST and a second QFT. The TST-negative group comprised individuals for whom both TSTs had an induration diameter of <10 mm. The confirmed-negative group comprised individuals for whom both TSTs yielded no detectable induration and results of both QFTs were negative.Results.A total of 67 immunocompetent subjects with positive results of a previous TST were enrolled in the study. Of 56 subjects who completed the TST protocol, 25 (44.6%; 95% confidence interval [CI], 31.6%-57.6%) were TST negative (P<.001). Of 31 subjects who completed the TST protocol and the QFT protocol, 8 (25.8%; 95% CI, 10.4%-41.2%) were confirmed negative (P<.005).Conclusions.A significant proportion of subjects with positive results of a previous TST were TST negative in this study, and a subset of these were confirmed negative. These individuals' TST status may have reverted or may never have been positive. It will be important in future studies to determine whether such individuals lack immunity to tuberculosis and whether they should be considered for reentry into tuberculosis screening programs.

scholarly journals Future of Personalized Medicine in Oncology: A Systems Biology Approach

2010 ◽  
Vol 28 (16) ◽  
pp. 2777-2783 ◽  
Author(s):  
Ana Maria Gonzalez-Angulo ◽  
Bryan T.J. Hennessy ◽  
Gordon B. Mills
Keyword(s):  
Systems Biology ◽  
Patient Outcomes ◽  
Cost Effective ◽  
Molecular Medicine ◽  
Multidimensional Data ◽  
Data Sets ◽  
Therapeutic Modalities ◽  
Molecular Tests ◽  
Therapeutic Decision Making ◽  
The Masses

The development of cost-effective technologies able to comprehensively assess DNA, RNA, protein, and metabolites in patient tumors has fueled efforts to tailor medical care. Indeed validated molecular tests assessing tumor tissue or patient germline DNA already drive therapeutic decision making. However, many theoretical and regulatory challenges must still be overcome before fully realizing the promise of personalized molecular medicine. The masses of data generated by high-throughput technologies are challenging to manage, visualize, and convert to the knowledge required to improve patient outcomes. Systems biology integrates engineering, physics, and mathematical approaches with biologic and medical insights in an iterative process to visualize the interconnected events within a cell that determine how inputs from the environment and the network rewiring that occurs due to the genomic aberrations acquired by patient tumors determines cellular behavior and patient outcomes. A cross-disciplinary systems biology effort will be necessary to convert the information contained in multidimensional data sets into useful biomarkers that can classify patient tumors by prognosis and response to therapeutic modalities and to identify the drivers of tumor behavior that are optimal targets for therapy. An understanding of the effects of targeted therapeutics on signaling networks and homeostatic regulatory loops will be necessary to prevent inadvertent effects as well as to develop rational combinatorial therapies. Systems biology approaches identifying molecular drivers and biomarkers will lead to the implementation of smaller, shorter, cheaper, and individualized clinical trials that will increase the success rate and hasten the implementation of effective therapies into the clinical armamentarium.

scholarly journals 1582. In Vitro Activity of Ceftolozane/Tazobactam against Enterobacterales and Pseudomonas aeruginosa Isolates from Geriatric Patients in the Asia/Pacific region – SMART 2016-2018

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S788-S789
Author(s):  
Sibylle Lob ◽  
Meredith Hackel ◽  
Wei-Ting Chen ◽  
Yivonne Khoo ◽  
Kanchan Balwani ◽  
...  
Keyword(s):  
Hong Kong ◽  
Urinary Tract ◽  
Length Of Hospital Stay ◽  
Asia Pacific ◽  
Surveillance Program ◽  
Independent Contractor ◽  
In Vitro Susceptibility ◽  
Specimen Collection ◽  
Genes Encoding

Abstract Background Ceftolozane/tazobactam (C/T) is an antipseudomonal cephalosporin combined with a β-lactamase inhibitor approved by FDA and EMA for complicated urinary tract and intraabdominal infections, and hospital-acquired and ventilator-associated bacterial pneumonia. We evaluated the activity of C/T against isolates collected from patients ≥65 years old as part of the SMART surveillance program in Asia/Pacific. Methods In 2016-2018, 49 clinical laboratories in Australia, Hong Kong, Malaysia, New Zealand, Philippines, Singapore, Korea, Taiwan, Thailand, and Vietnam each collected up to 250 consecutive gram-negative pathogens per year. Susceptibility was determined using CLSI broth microdilution and breakpoints. C/T-nonsusceptible (NS) Enterobacterales (ENT) and P. aeruginosa (PA) isolates were screened by PCR and sequenced for genes encoding β-lactamases (except ENT from 1 site in Taiwan). Results 2082 PA (68.3% lower respiratory tract, 12.7% intraabdominal, 15.1% urinary tract, and 3.0% bloodstream infection isolates) and 8181 ENT isolates (29.8%, 27.8%, 32.5%, and 9.2%, respectively) were collected from patients ≥65 years old. In vitro susceptibility of PA and ENT stratified by length of hospital stay at time of specimen collection (LOS) is shown (Table). C/T maintained activity against 75.5% of 518 P/T-NS, 67.9% of 395 cefepime-NS, and 71.6% of 377 meropenem-NS PA isolates. Among 136 C/T-NS PA isolates, 44.9% carried metallo-β-lactamases (MBL), 0.7% KPC, 1.5% GES carbapenemases, 5.9% only ESBL, and in 47.1% no acquired β-lactamases were detected. Among 878 characterized C/T-NS ENT, 14.1% carried MBL, 5.2% KPC, 3.3% OXA-48-like carbapenemases, and 53.5% AmpC and/or ESBL; no acquired β-lactamases were detected in 23.8% of isolates, of which 89.5% were species with intrinsic AmpC. Table Conclusion Susceptibility of PA and ENT to all studied agents was lower for isolates collected ≥48 than &lt; 48 hours post-admission. C/T was active against &gt;92% of PA in both strata, 7-29 percentage points higher than the studied comparators except amikacin, and against &gt;84% of ENT, 4-30% higher than the comparators except meropenem and amikacin. C/T is a potential new treatment option for older patients with infections caused by ENT and PA in Asia/Pacific. Disclosures Sibylle Lob, PhD, IHMA (Employee)Pfizer, Inc. (Consultant) Wei-Ting Chen, MD, Merck, Sharp & Dohme, Taiwan (Employee) Yivonne Khoo, PhD, Merck, Sharp & Dohme, Malaysia (Employee) Kanchan Balwani, MBBS, MS, Merck, Sharp & Dohme, Hong Kong (Employee) Katherine Young, MS, Merck & Co., Inc. (Employee, Shareholder)Merck & Co., Inc. (Employee, Shareholder) Mary Motyl, PhD, Merck & Co, Inc (Employee, Shareholder) Daniel F. Sahm, PhD, IHMA (Employee)Pfizer, Inc. (Consultant)Shionogi & Co., Ltd. (Independent Contractor)

Effect of chronic hypoxia on myometrial responsiveness in the pregnant rat

1996 ◽  
Vol 270 (3) ◽  
pp. E477-E482 ◽  
Author(s):  
J. W. Rhee ◽  
L. D. Longo ◽  
W. J. Pearce ◽  
N. H. Bae ◽  
G. J. Valenzuela ◽  
...  
Keyword(s):  
Binding Sites ◽  
Chronic Hypoxia ◽  
Contractile Response ◽  
Plasma Concentrations ◽  
Hypoxic Exposure ◽  
Normal System ◽  
Pregnant Rat ◽  
Near Term ◽  
Air Control

Mechanisms involving the timing of normal parturition are not well understood in most animal species. To gain a greater understanding of the mechanisms, we employed hypoxia to perturb the normal system of parturition. The present study was designed to investigate the effects of chronic hypoxia on myometrial contractility in the near-term pregnant rat. Rats were exposed to room air (control) or to continuous hypoxia (10.5% O2) either from experimental days 19 through 21 (2-day exposure) or from experimental days 15 through 21 (6-day exposure). On day 21, blood was collected for hormone assays, and the uterine horns were collected from each dam. One horn was snap-frozen in liquid nitrogen for oxytocin (OT) receptor analysis, and the other was used for in vitro assessment of myometrial contractile responses to cumulative doses of OT or arginine vasopressin (AVP). Hypoxic exposure resulted in approximately 60% reduction of the maximal myometrial contractile response to OT and a significant reduction in OT binding sites from 256.9 +/- 34.9 to 84.9 +/- 21.3 fmol/mg protein (P<0.01). In contrast, the contractile response to AVP was unaffected after exposure to chronic hypoxia (P> 0.05). Additionally, we observed no difference in the plasma concentrations of estrogen, progesterone, and corticosterone. We conclude that chronic hypoxia decreased the effectiveness of OT-specific contractile mechanisms, at least partially through a decrease in OT binding sites.

scholarly journals The Prevalence and Incidence of Congenital Phenylketonuria in 59 Countries: A Systematic Review

2021 ◽  
Vol 9 (2) ◽  
pp. 83-96
Author(s):  
Nastaran Mojibi ◽  
◽  
Shabnam Ghazanfari-Sarabi ◽  
Seyed Mohammad Bagher Hashemi-Soteh ◽  
◽  
...  
Keyword(s):  
Systematic Review ◽  
Financial Burden ◽  
Incidence Rates ◽  
Management Program ◽  
Screening Programs ◽  
Related Data ◽  
Current Systematic Review ◽  
High Prevalence ◽  
Shed Light

Context: Phenylketonuria (PKU) is the most frequent inborn error of metabolism, in which newborns cannot metabolize phenylalanine to tyrosine. Increased phenylalanine in untreated patients with PKU can cause serious intellectual disability; its onerous financial burden also falls on societies. This review study aimed to systematically indicate the frequency of PKU worldwide. We also intended to highlight the global prevalence of PKU, which might shed light on better clinical management and screening programs. Methods: In this systematic review, two electronic databases, including PubMed and ScienceDirect were searched for the related literature using relevant keywords: “Phenylketonuria” or “PKU” and “Prevalence” or “Incidence” and “Iran” or “Middle East” or “Europe” or “America” or “Asia.” Accordingly, 4306 reports conducted on PKU from January 2007 to December 2018 were retrieved. With the removal of 44 duplicated publications, 44 reports were included in the current systematic review. Prevalence and incidence rates were categorized based on different continents in which nations used various NBS programs to report the incidence and prevalence of PKU. Non-English, non-eligible, duplicated, animal, and in vitro studies are excluded. Results: Based on the reported quantitative data, the prevalence of PKU diagnosed worldwide ranged from 0.00044% to 0.02736% in which Italy possessed the highest prevalence; however, Thailand manifested the lowest prevalence rate. However, for some countries, such as India or Finland, either the related data to the frequency of PKU was outdated or overlooked applying any newborn screening programs respecting PKU. Conclusions: The current study revealed an elevated prevalence of PKU in Iran, compared with other Asian countries; thus, it demands a more serious management program. Moreover, the high prevalence of PKU in European countries should not be underestimated.

Mycobacterium avium Abortion in a Sow

1979 ◽  
Vol 16 (3) ◽  
pp. 310-317 ◽  
Author(s):  
S. R. Ellsworth ◽  
C. A. Kirkbride ◽  
D. D. Johnson ◽  
M. W. Vorhies
Keyword(s):  
Lymph Nodes ◽  
Mycobacterium Avium ◽  
Fetal Tissue ◽  
Reproductive Organs ◽  
Histologic Examination ◽  
Skin Tests ◽  
Tuberculous Infection ◽  
Serotype 1 ◽  
Near Term

A 2-year-old sow aborted her entire near-term litter of 11. Gross and histologic examination of a fetus suggested a tuberculous infection, and a yellow-pigmented Mycobacterium avium serotype 1 was subsequently isolated from the fetal tissue. Efforts to rebreed the sow were unsuccessful. She was anergic to skin tests with purified protein derivative of M. avium on two occasions but had M. avium specific in vitro lymphocyte immunostimulation. Gross granulomatous lesions were found in the liver, kidneys, and endometrium when the sow was necropsied 5 months after the abortion. Histologic examination showed diffuse and focal non-encapsulated granulomas in lymph nodes, tonsils, kidney, liver, spleen, lung, and uterine and vaginal walls. There were a few encapsulated calcified foci in the endometrium. The centers of some granulomas in the tonsils, liver, kidneys, and some lymph nodes were caseated. The yellow-pigmented M. avium was isolated from the reproductive organs and from 11 of 12 other tissues cultured.

scholarly journals Multicenter evaluation of TB-SPRINT 59-Plex Beamedex®: accuracy and cost analysis

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Regina Bones Barcellos ◽  
Isabela Neves de Almeida ◽  
Elisangela Costa da Silva ◽  
Harrison Magdinier Gomes ◽  
Lida Jouca de Assis Figueredo ◽  
...  
Keyword(s):  
Multidrug Resistant ◽  
Cost Evaluation ◽  
Laboratory Research ◽  
Activity Based Costing ◽  
In Vitro Diagnostics ◽  
Isoniazid Resistance ◽  
Molecular Tests ◽  
Mdr Tb ◽  
Mean Cost

Abstract Background Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDR-TB). TB-SPRINT 59-Plex Beamedex® is a microbead-based assay developed for the simultaneous spoligotyping and detection of MDR-TB. The accuracy and cost evaluation of new assays and technologies are of great importance for their routine use in clinics and in research laboratories. The aim of this study was to evaluate the performance of TB-SPRINT at three laboratory research centers in Brazil and calculate its mean cost (MC) and activity-based costing (ABC). Methods TB-SPRINT data were compared with the phenotypic and genotypic profiles obtained using Bactec™ MGIT™ 960 system and Genotype® MTBDRplus, respectively. Results Compared with MGIT, the accuracies of TB-SPRINT for the detection of rifampicin and isoniazid resistance ranged from 81 to 92% and 91.3 to 93.9%, respectively. Compared with MTBDRplus, the accuracies of TB-SPRINT for rifampicin and isoniazid were 99 and 94.2%, respectively. Moreover, the MC and ABC of TB-SPRINT were USD 127.78 and USD 109.94, respectively. Conclusion TB-SPRINT showed good results for isoniazid and rifampicin resistance detection, but still needs improvement to achieve In Vitro Diagnostics standards.

Recommendations for detection and management of unsuitable samples in clinical laboratories

2007 ◽  
Vol 45 (6) ◽  
Author(s):  
Giuseppe Lippi ◽  
Giuseppe Banfi ◽  
Mauro Buttarello ◽  
Ferruccio Ceriotti ◽  
Massimo Daves ◽  
...  
Keyword(s):  
Clinical Biochemistry ◽  
Large Body ◽  
Laboratory Methods ◽  
Clinical Laboratories ◽  
Specimen Collection ◽  
Quality Programs ◽  
Unsuitable Samples ◽  
Analytical Phase ◽  
Total Testing Process

AbstractA large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in clinical laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in clinical laboratories, providing consensus recommendations for detection and management.Clin Chem Lab Med 2007;45:728–36.

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