OBJECTIVE: To early differentiate between coronavirus disease 2019 (COVID-19) and adult mycoplasma pneumonia with chest CT scan. METHODS: Twenty-six patients with COVID-19 and 21 patients with adult mycoplasma pneumonia confirmed with RT-PCR test were enrolled from Zibo First Hospital and Lanshan People's Hospital during December 1st 2019 and March 14th 2020. The early chest CT manifestations were analyzed and compared between the two groups. RESULTS: The interstitial changes with ground glass density shadow (GGO) were similar in two groups during first chest CT examination (>0.05). There were more lung lobes involved on the first chest CT in COVID-19 patients, which were mostly distributed in the dorsal outer zone (23/26, 88.5%), and nearly half of them (12/26, 46.2%) were accompanied by crazy-paving sign; while the lesions in adult mycoplasma pneumonia patients were mostly distributed along the bronchi, and the bronchial wall was thickened (19/21, 90.5%), accompanied with tree buds / fog signs (19/21, 90.5%). The above CT signs were significantly different between the two kinds of pneumonia (all <0.01). COVID-19 had a longer course compared with mycoplasma pneumonia, the disease peaks of COVID-19 patients was on day (10.5±3.8), while the disease on CT was almost absorbed on day (7.9±2.2) in adult mycoplasma pneumonia. The length of hospital stay in COVID-19 patients was significantly longer than that of mycoplasma pneumonia patients [(19.5±4.3) d vs (7.9±2.2) d, <0.01]. CONCLUSIONS The lesions of adult mycoplasma pneumonia are mostly distributed along the bronchi with tree buds/fog signs, while the lesions of COVID-19 are mainly distributed in the dorsal outer zone accompanied by crazy-paving sign, which can early distinguish two diseases.
Adult ; Betacoronavirus ; Clinical Laboratory Techniques ; standards ; Coronavirus Infections ; diagnosis ; diagnostic imaging ; Diagnosis, Differential ; Humans ; Lung ; diagnostic imaging ; Pandemics ; Pneumonia, Mycoplasma ; diagnostic imaging ; Pneumonia, Viral ; diagnostic imaging ; Tomography, X-Ray Computed

OBJECTIVE: To investigate the clinical outcome of patients with moderate type of corona virus disease 2019 (COVID-19) after discharge by retesting viral nucleic acid. METHODS: Seven patients with moderate COVID-19 met the discharge criteria enacted by National Health Commission were quarantine in hospital for 7 days, then continuously quarantined at home for 4 weeks after discharged. During the three weeks of quarantined period, the symptoms and signs were documented; and sputum or nasal swab and feces samples were collected to test SARS-COV-2 nucleic acid by RT-PCR method. RESULTS: There were no symptoms and signs during the quarantine period in all 7 patients. However, respiratory swabs from 3 patients were confirmed positive of SARS-COV-2 nucleic acid at 5 to 7 days after they met the discharge criteria. CONCLUSIONS The study indicates that there is a relatively high incidence of positive viral nucleic acid in patients met the discharge criteria, and it is suggested that patients met the current discharge criteria should be quarantined in hospital for another 7 days and the follow-up viral testing is necessary.
Asymptomatic Diseases ; Betacoronavirus ; genetics ; China ; Clinical Laboratory Techniques ; Coronavirus Infections ; diagnosis ; virology ; Follow-Up Studies ; Humans ; Pandemics ; Patient Discharge ; standards ; Pneumonia, Viral ; diagnosis ; virology ; Quarantine ; Reverse Transcriptase Polymerase Chain Reaction ; Time Factors

BACKGROUND: It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. METHODS: We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. RESULTS: A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). CONCLUSIONS: Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections.
Clinical Laboratory Services/*standards ; Clinical Laboratory Techniques/instrumentation/methods ; Coronavirus Infections/*diagnosis/epidemiology/virology ; Disease Outbreaks ; Humans ; Middle East Respiratory Syndrome Coronavirus/genetics/isolation & purification ; RNA, Viral/analysis ; Real-Time Polymerase Chain Reaction ; Republic of Korea/epidemiology ; Sputum/virology ; Surveys and Questionnaires

No abstract available.
*Algorithms ; Automation ; Clinical Laboratory Information Systems/*standards ; Humans ; Immunoassay/*methods ; Indicator Dilution Techniques ; alpha-Fetoproteins/*analysis

BACKGROUND: We investigated the influence of pre-analytical factors on the results of clinical tests and thereby analyzed approaches to improve quality management in clinical laboratories. METHODS: Unqualified clinical samples were selected from all the samples received at our clinical laboratory. The data were collected for 2009 and 2010, i.e., the years before and after the establishment of the laboratory quality management system. The rate and causes of generation of unqualified samples were analyzed, and measures to improve the laboratory practices were studied and implemented. RESULTS: A total of 1,051 unqualified samples were identified from among the 553,158 samples (the overall incidence rate of unqualified samples was 0.19%). The number of unqualified samples substantially varied according to the nature of the sample, and clinical samples collected for routine blood tests or coagulation tests were the predominant unqualified samples. The main causes of generation of unqualified samples were insufficient sample volumes and improper methods of mixing the samples. The rate of generation of unqualified samples decreased significantly after the implementation of improvement measures (0.26% in 2009 vs. 0.13% in 2010, P<0.001). CONCLUSIONS: The number of unqualified samples decreased significantly after the establishment of the laboratory quality management system, which promoted active communication among and training of the clinical staff to reduce the occurrence of pre-analytical errors. Comprehensive control of pre-analytical factors is an important approach in improving the clinical laboratory practices.
Clinical Laboratory Techniques/standards ; Diagnostic Errors/statistics & numerical data ; Humans ; Laboratories, Hospital/*standards ; Specimen Handling/standards

For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation of the prevalence of errors in the pre- and post-analytical phases and their potential for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory.
Clinical Laboratory Techniques/standards ; Diagnostic Errors ; Humans ; Laboratories/*standards ; Quality Assurance, Health Care/standards ; Specimen Handling

Better biomarkers are urgently needed to cancer detection, diagnosis, and prognosis. While the genomics community is making significant advances in understanding the molecular basis of disease, proteomics will delineate the functional units of a cell, proteins and their intricate interaction network and signaling pathways for the underlying disease. Great progress has been made to characterize thousands of proteins qualitatively and quantitatively in complex biological systems by utilizing multi-dimensional sample fractionation strategies, mass spectrometry and protein microarrays. Comparative/quantitative analysis of high-quality clinical biospecimen (e.g., tissue and biofluids) of human cancer proteome landscape has the potential to reveal protein/peptide biomarkers responsible for this disease by means of their altered levels of expression, post-translational modifications as well as different forms of protein variants. Despite technological advances in proteomics, major hurdles still exist in every step of the biomarker development pipeline. The National Cancer Institute's Clinical Proteomic Technologies for Cancer initiative (NCI-CPTC) has taken a critical step to close the gap between biomarker discovery and qualification by introducing a pre-clinical "verification" stage in the pipeline, partnering with clinical laboratory organizations to develop and implement common standards, and developing regulatory science documents with the US Food and Drug Administration to educate the proteomics community on analytical evaluation requirements for multiplex assays in order to ensure the safety and effectiveness of these tests for their intended use.
Biological Markers/analysis ; Clinical Laboratory Techniques/standards ; *Genomics ; Humans ; Mass Spectrometry/methods/standards ; Neoplasms/*diagnosis/genetics ; *Proteomics ; Quality Control ; United States ; United States Food and Drug Administration

Biological Products ; standards ; China ; Clinical Laboratory Techniques ; instrumentation ; standards ; Laboratories ; standards ; Safety Management ; legislation & jurisprudence ; standards

A new non-destructive and rapid method was developed to discriminate the coating process of Rukuaixiao tablets mainly based the support vector machine (SVM) with the near-infrared spectroscopy (NIRs). After the samples that differ in the sugar-coat were acquired, the sample set partitioning based on joint x-y distance (SPXY) method was used to select the training sets and internal principal component analysis (internal PCA) was to select the optimal wavelength. The discrimination model was developed based on support vector machine (SVM), and varieties of pre-processing methods were compared. The results showed that the accuracy of the prediction set was 98.81%. It is concluded that the accuracy of the method is high to use for the quality evaluation of tablet's coating process.
Algorithms ; Clinical Laboratory Techniques ; standards ; Clinical Protocols ; standards ; Drugs, Chinese Herbal ; analysis ; Medicine, Chinese Traditional ; standards ; Medicine, East Asian Traditional ; methods ; Principal Component Analysis ; Spectrophotometry, Infrared ; methods ; Spectroscopy, Near-Infrared ; methods ; Tablets ; analysis

Traditional Chinese medicine (TCM) and Western medicine have the common purpose and can complement each other, though they belong to different medical systems. Laboratory medicine can provide the scientific bases for modernization and standardization of TCM by offering elaborate and objective laboratory data. Fully playing the role of laboratory medicine in TCM diagnosis and treatment will not only be beneficial to the rush of TCM out of China toward the world, and also be favorable to the innovating and developing of laboratory medicine in integrative medicine.
Biomarkers ; blood ; Clinical Laboratory Techniques ; Diagnosis, Differential ; Humans ; Medicine, Chinese Traditional ; methods ; standards