Objective: The aim of the present study was to evaluate the performance of the simultaneous detection of HIV-1 RNA, HIV-1 DNA, and HCV RNA using one dried blood spot (DBS) as an alternative sample to plasma. Method: A total of 571 paired DBS/plasma samples were collected from men who have sex with men (MSM) and injection drug users (IDUs), and serological and molecular assays were performed. Using plasma results as the reference standard, the performance of DBS tests for HIV-1 RNA, HIV-1 DNA, and HCV RNA was evaluated. Pearson's correlation coefficients and Bland-Altman analysis were performed to assess the correlation and concordance between DBS and plasma. Results: Among paired plasma/DBS samples with detectable HIV-1 RNA and HCV RNA, five samples (5/32) were not detectable in DBS, while measurable HIV-1 RNA levels were present in plasma (1.44 to 3.99 log Conclusion The performance of the simultaneous detection of HIV-1 RNA, HIV-1 DNA, and HCV RNA using one DBS was acceptable. DBS, as an alternative sample to plasma, may be a viable option for the simultaneous detection of HIV-1 RNA, HIV-1 DNA, and HCV RNA in resource-limited settings or for individuals living in areas that are difficult to access.
DNA, Viral/analysis* ; Diagnostic Tests, Routine/methods* ; Dried Blood Spot Testing/methods* ; HIV Infections/diagnosis* ; HIV-1/isolation & purification* ; Hepacivirus/isolation & purification* ; Hepatitis C/diagnosis* ; RNA, Viral/analysis* ; Sensitivity and Specificity ; Specimen Handling/methods* ; Syphilis/diagnosis* ; Treponema pallidum/isolation & purification*

Point-of-care testing (POCT) is a test method performed on the sampling site or patient bedside. Accurate results can be achieved rapidly by the application of portable analytical instruments and compatible reagents. It has been widely used in the field of in vitro diagnosis (IVD). Paper-based microfluidics technology has great potential in developing POCT due to its advantages in low cost, simple operation, rapid detection, portable equipment, and unrestricted application conditions. In recent years, the development of paper-based microfluidic technology and its integration with various new technologies and methods have promoted the substantial development of POCT technology and methods. The classification and characteristic of the paper are summarized in this review. Paper-based microfluidic sample pretreatment methods, the flow control in the process of reaction and the signal detecting and analyzing methods for the testing results are introduced. The research progress of various kinds of microfluidic paper-based analytical devices (μPADs) toward POCT in recent years is reviewed. Finally, remaining problems and the future prospects in POCT application of paper-based microfluidics are discussed.
Diagnostic Tests, Routine ; methods ; Humans ; Microfluidic Analytical Techniques ; instrumentation ; Paper ; Point-of-Care Testing

Real-time quaking-induced conversion (RT-QuIC) assay is a newly established PrP -detecting method. The development of RT-QuIC improves the diagnosis of sporadic Creutzfeldt-Jakob disease (sCJD), showing good sensitivity and specificity in many countries when the method was used in cerebrospinal fluid (CSF) samples. However, in China, the sensitivity and specificity of RT-QuIC has yet to be determined due to the lack of definitive diagnosis samples. Recently, 30 definitive sCJD and 30 non-CJD diagnoses were evaluated by RT-QuIC assay. In the 30 sCJD CSF samples, 29 showed positive results. By contrast, all the non-CJD samples were negative. The sensitivity and specificity of our RT-QuIC assay were 96.67% and 100%, respectively, and are comparable to other published data. Results can provide a fundamental basis for the usage of RT-QuIC assay in CJD surveillance in China.
China ; Creutzfeldt-Jakob Syndrome ; diagnosis ; Diagnostic Tests, Routine ; methods ; Humans ; PrPSc Proteins ; cerebrospinal fluid ; Sensitivity and Specificity

Diagnostic Tests, Routine ; methods ; Humans ; Mycobacterium tuberculosis ; isolation & purification ; Sensitivity and Specificity ; Tuberculosis, Pulmonary ; diagnosis ; microbiology

BACKGROUND: Rotavirus is a major pathogen causing enteritis worldwide in children under five years of age. In recent years, immunochromatographic assay (ICA) has been widely used as a diagnostic test for rotavirus detection. This study aimed to compare and evaluate the performance of ICA-based rotavirus rapid test kits from two manufacturers. METHODS: Residual stool samples from a total of 130 children with acute enterocolitis from November 2017 to January 2018 were used. We compared the results of the two immunochromatographic methods (SD BIOLINE Rotavirus kit and GENEDIA Rotavirus Ag Rapid Test) with those of the currently used enzyme immunoassay method. RESULTS: Positive agreement, negative agreement, and total agreement rates between the SD BIOLINE rotavirus kit and the enzyme immunoassay were 98.0%, 100%, and 99.2%, respectively. Positive agreement, negative agreement, and total agreement rates between the GENEDIA Rotavirus Ag Rapid Test and the enzyme immunoassay were 96.0%, 100%, and 98.4%, respectively. CONCLUSIONS: Both rotavirus rapid test kits showed very good agreement with the conventional enzyme immunoassay. Therefore, it could be a useful test to detect rotavirus directly from stool samples in a short time.
Child ; Diagnostic Tests, Routine ; Enteritis ; Enterocolitis ; Humans ; Immunochromatography ; Immunoenzyme Techniques ; Methods ; Rotavirus

OBJECTIVES: Ultrasound has an established role in the diagnostic pathway for children with suspected appendicitis. Relevant clinical information can influence the diagnostic probability and reporting of ultrasound findings. A Bayesian network (BN) is a directed acyclic graph (DAG) representing variables as nodes connected by directional arrows permitting visualisation of their relationships. This research developed a BN model with ultrasonographic and clinical variables to predict acute appendicitis in children. METHODS: A DAG was designed through a hybrid method based on expert opinion and a review of literature to define the model structure; and the discretisation and weighting of identified variables were calculated using principal components analysis, which also informed the conditional probability table of nodes. RESULTS: The acute appendicitis target node was designated as an outcome of interest influenced by four sub-models, including Ultrasound Index, Clinical History, Physical Assessment, and Diagnostic Tests. These sub-models included four sonographic, three blood-test, and six clinical variables. The BN was scenario tested and evaluated for face, predictive, and content validity. A lack of similar networks complicated concurrent and convergent validity evaluation. CONCLUSIONS: To our knowledge, this is the first BN model developed for the identification of acute appendicitis incorporating imaging variables. It has particular benefit for cases in which variables are missing because prior probabilities are built into corresponding nodes. It will be of use to clinicians involved in ultrasound examination of children with suspected appendicitis, as well as their treating clinicians. Prospective evaluation and development of an online tool will permit validation and refinement of the BN.
Appendicitis ; Bayes Theorem ; Child ; Diagnostic Tests, Routine ; Emergency Medicine ; Expert Testimony ; Humans ; Methods ; Pediatrics ; Prospective Studies ; Ultrasonography

Work-related asthma is the most common occupational lung disease encountered in clinical practice. In adult asthmatics, work-relatedness can account for 15%–33% of cases, but delays in diagnosis remain common and lead to worse outcomes. Accurate diagnosis of asthma is the first step to managing occupational asthma, which can be sensitizer-induced or irritant-induced asthma. While latency has traditionally been recognized as a hallmark of sensitizer-induced asthma and rapid-onset a defining feature of irritant-induced asthma (as in Reactive Airway Dysfunction Syndrome), there is epidemiological evidence for irritant-induced asthma with latency from chronic moderate exposure. Diagnostic testing while the patient is still in the workplace significantly improves sensitivity. While specific inhalational challenges remain the gold-standard for the diagnosis of occupational asthma, they are not available outside of specialized centers. Commonly available tests including bronchoprovocation challenges and peak flow monitoring are important tools for practicing clinicians. Management of sensitizer-induced occupational asthma is notable for the central importance of removal from the causative agent: ideally, removal of the culprit agent; but if not feasible, this may require changes in the work process or ultimately, removal of the worker from the workplace. While workers' compensation programs may reduce income loss, these are not universal and there can be significant socio-economic impact from work-related asthma. Primary prevention remains the preferred method of reducing the burden of occupational asthma, which may include modification to work processes, better worker education and substitution of sensitizing agents from the workplace with safer compounds.
Adult ; Asthma ; Asthma, Occupational ; Case Management ; Diagnosis ; Diagnostic Tests, Routine ; Education ; Humans ; Lung Diseases ; Methods ; Primary Prevention ; Workers' Compensation

Fine needle aspiration cytology is gold standard for diagnosis of thyroid nodule. However, it is not perfect and its results are cytologically indeterminate nodules (Bethesda classification III-V) in 15-30%, which remains diagnostic challenges. So, the method that provide information about cancer risk is necessary to establish management strategy. As results of studies about genetic changes in thyroid cancer, remarkable advances have been achieved in understanding thyroid carcinogenesis, which produced applications of molecular biomarkers and profiling panels for diagnosis of thyroid nodule. These tests help clinicians make decision regarding the need for surgery and the surgical extent. In this review, published researches related to molecular diagnosis of thyroid cancer are reviewed and performance of the diagnostic tests and its interpretation were discussed.
Biomarkers ; Biopsy, Fine-Needle ; Carcinogenesis ; Classification ; Diagnosis* ; Diagnostic Tests, Routine ; Genetic Testing ; Methods ; Molecular Diagnostic Techniques ; Thyroid Gland* ; Thyroid Neoplasms ; Thyroid Nodule*

We developed a Rapid Diagnostic Test (RDT) kit for detecting IgG/IgM antibodies against Zika virus (ZIKV) using monoclonal antibodies to the envelope (E) and non-structural protein 1 (NS1) of ZIKV. These proteins were produced using baculovirus expression vector with Sf9 cells. Monoclonal antibodies J2G7 to NS1 and J5E1 to E protein were selected and conjugated with colloidal gold to produce the Zika IgG/IgM RDT kit (Zika RDT). Comparisons with ELISA, plaque reduction neutralization test (PRNT), and PCR were done to investigate the analytical sensitivity of Zika RDT, which resulted in 100% identical results. Sensitivity and specificity of Zika RDT in a field test was determined using positive and negative samples from Brazil and Korea. The diagnostic accuracy of Zika RDT was fairly high; sensitivity and specificity for IgG was 99.0 and 99.3%, respectively, while for IgM it was 96.7 and 98.7%, respectively. Cross reaction with dengue virus was evaluated using anti-Dengue Mixed Titer Performance Panel (PVD201), in which the Zika RDT showed cross-reactions with DENV in 16.7% and 5.6% in IgG and IgM, respectively. Cross reactions were not observed with West Nile, yellow fever, and hepatitis C virus infected sera. Zika RDT kit is very simple to use, rapid to assay, and very sensitive, and highly specific. Therefore, it would serve as a choice of method for point-of-care diagnosis and large scale surveys of ZIKV infection under clinical or field conditions worldwide in endemic areas.
Antibodies ; Antibodies, Monoclonal ; Baculoviridae ; Brazil ; Cross Reactions ; Dengue Virus ; Diagnosis ; Diagnostic Tests, Routine ; Enzyme-Linked Immunosorbent Assay ; Flavivirus ; Gold Colloid ; Hepacivirus ; Immunoglobulin G ; Immunoglobulin M ; Korea ; Methods ; Neutralization Tests ; Point-of-Care Systems ; Polymerase Chain Reaction ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Sf9 Cells ; Yellow Fever ; Zika Virus

BACKGROUND AND OBJECTIVES: Specific IgE assays are important in the diagnosis and treatment of allergic rhinitis (AR). Among the diagnostic tests of AR, multiple allergen simultaneous test (MAST) and ImmunoCAP have been frequently used as simple, safe, and economical methods. In this study, we compared the diagnostic outcomes of MAST and ImmunoCAP in patients with AR. SUBJECTS AND METHOD: Seventy-eight patients (52 men, 26 women, mean age 34.5 years: range 6–80 years), who have nasal symptoms of allergy and no clinical factors to influence the test results, underwent routine skin prick test (SPT) and MAST, and ImmunoCAP for eight major allergens. The diagnosis of AR was based on the criteria of SPT. The class 1 responses or more were regarded as positive for both MAST and ImmunoCAP. The agreements, sensitivities, and specificities of MAST and ImmunoCAP were evaluated along with the correlation between the two tests. RESULTS: Total agreement rates of MAST and ImmunoCAP amounted to 91.5 and 92.1%, respectively. The overall sensitivity and specificity of MAST were 73.4 and 95.3%, respectively, and those of ImmunoCAP were 81.4 and 94.5%, respectively. The correlations between MAST and ImmunoCAP showed statistical significance for Dermatophagoides pteronyssinus/Dermatophagoides farinae. CONCLUSION: Our study demonstrated the diagnostic usefulness of both MAST and ImmunoCAP in AR, especially for the most prevalent allergens of house dust mites. Moreover, ImmunoCAP, which showed higher sensitivity than MAST, can be effectively used in rhinology clinics.
Allergens ; Diagnosis ; Diagnostic Tests, Routine ; Female ; Humans ; Hypersensitivity ; Immunoglobulin E ; Male ; Methods ; Pyroglyphidae ; Rhinitis, Allergic ; Sensitivity and Specificity ; Skin