Quality assurance of malaria rapid diagnostic tests: An aid in malaria elimination

Background & objectives: India targets malaria elimination by 2030 in a phased manner, so malaria’s assured diagnosis is crucial. Introduction of rapid diagnostic kits in India in 2010 has revolutionized malaria surveillance. The storage temperature of rapid diagnostic tests (RDTs), kit components and handling in transportations impact the results of RDTs. Therefore, quality assurance (QA) is required before it reaches end-users. The Indian Council of Medical Research-National Institute of Malaria Research (ICMR-NIMR) has a World Health Organization (WHO) recognized lot-testing laboratory facility to assure the quality of RDTs. Methods: The ICMR-NIMR receives RDTs from different manufacturing companies as well as various agencies such as National and State Programmes and Central Medical Services Society. The WHO standard protocol is followed to conduct all the tests, including long-term and post-dispatch testing. Results: A total of 323 lots tested during January 2014-March 2021 were received from different agencies. Amongst them, 299 lots passed the quality of test and 24 failed. In long-term testing, 179 lots were tested and only nine failed. A total of 7741 RDTs were received from end-users for post-dispatch testing of which 7540 qualified the QA test with a score of 97.4 per cent. Interpretation & conclusions: RDTs received for quality testing showed compliance with QA evaluation of malaria RDTs based on the protocol recommended by the WHO. However, continuous monitoring of the quality of RDTs is required under QA programme. Quality-assured RDTs have a major role, especially in areas where low parasitaemia of parasites persists.

Experience of quantity and quality of DNA and RNA extraction from limited pediatric blood samples: A comparative analysis of automated and manual kit-based method

Introduction: Optimal DNA and RNA quantity and purity is essential for downstream molecular biology experimentation and to avoid re-processing of sample. Despite availability of different kits and automated systems for nucleic acid isolation there is limited data on their performance evaluation, more so with pediatric blood samples, that are usually compromised in quantity. Hence, we evaluated the performance of automated QIAcube platform using pediatric blood samples in parallel with manual Qiagen extraction kits. Materials and Methods: A total of 500 samples were analyzed based on groups of PBMC and direct blood input. The isolated DNA and RNA were surveyed for quantity and quality tests by spectrophotometric and downstream analysis. Results: There was no significant difference in the DNA quantity (ng/ul) between manual and automated method based on similar sample input but quality (260/280) was significantly better with the QIAcube platform when direct blood and or PBMCs were used for extraction respectively (1.82 ± 004 Vs. 1.84.002; P-0.000008 and 1.859 ± 005 Vs. 1.843 ± 0.003; P-0.02). Moreover, the standard error mean was low for both quantity and quality in the QIAcube method suggesting uniformity. Comparison of quality assessment by spectrophotometer and qubit fluorimeter showed that QIAcube sheared DNA less (P- 0.038) as compared to manual method (P-0.013). Also, time taken to process the samples in QIAcube was 23% less than the kit-based method. Conclusion: Overall analysis of QIAcube platform suggests that it yields more better, uniform, and less-sheared quality of nucleic acid in a relatively less time as compared to manual extraction kits.

Detection of recombinant dengue virus 2 NS1 protein in Aedes aegypti mosquitoes using commercial Dengue NS1 ELISA kit

Dengue, a vector-borne disease remains as one of the most serious public health problems globally. Incidence of this disease is on an increasing trend and currently over a billion people in tropical and subtropical regions are at risk. In the absence of an operational vaccine, prevention of dengue virus (DENV) is primarily focused upon controlling mosquito vectors. Mosquito vector surveillance programmes require simple and rapid tools to detect mosquitoes infected with DENV. Here, we tested the commercially available DENV Detect™ NS1 ELISA kit (InBios International, Inc.) for detection of recombinant DENV-NS1 protein in Aedes mosquito samples. The kit was evaluated to find out the minimum detection limit of recombinant DENV-2 NS1 protein following the manufacturer’s instructions. Initially, the NS1 protein detection threshold of the kit was determined and later the assay was standardized for detection of NS1 protein in Aedes aegypti mosquito pools containing 5, 10 and 25 mosquitoes. The ELISA kit displayed high sensitivity towards detection of recombinant dengue virus-2 NS1 protein in mosquito pools (up to 25 mosquitoes per pool) at 25 pico gram concentration. Since the commercial NS1 ELISA is highly sensitive and follows a very simple procedure, it could be employed for DENV surveillance in Aedes aegypti mosquitoes, after carrying out laboratory and field bioassays with DENV infected specimens.

La trazabilidad en las mediciones del laboratorio clínico: impacto en la calidad y seguridad del paciente / Traceability in clinical laboratory measurements: impact on quality and patient safety

Las mediciones confiables, trazables metrológicamente y comparables proporcionan la base racional para la evaluación de la calidad de un resultado y el fortalecimiento de las redes de laboratorios clínicos, lo cual permite mejorar la calidad de atención y la seguridad del paciente. En este documento se revisan los principios básicos que deben seguirse para garantizar la trazabilidad de las mediciones del laboratorio clínico, las ventajas de utilizar métodos trazables, el impacto de no hacerlo, y se discuten las principales limitaciones para relacionar las mediciones con los estándares de medición de referencia apropiados

Reliable, metrologically traceable, and comparable measurements provide the rationale for evaluating the quality of a result and strengthening clinical laboratory networks, thereby improving quality of care and patient safety. This document reviews the basic principles that must be followed to ensure the traceability of clinical laboratory results, the advantages of using traceable methods, the impact of not doing so, and the main limitations in relating measurements to appropriate reference standards

Performance evaluation of some domestically produced biochemical reagents / 中华检验医学杂志

Objective:To evaluation the performance of a total of 40 clinical biochemical reagents from three domestic manufacturers and two foreign manufacturers, and evaluate their clinical application value.Methods:The Beckman AU5400 automatic biochemical analyzer was used to verify the performance of 40 kinds of commonly used clinical biochemical reagents from three domestic manufacturers of Sichuan Maccura, Ningbo Medical System, and Shanghai Fosun Long March, and two foreign imported manufacturers of Roche and Japan′s Hitachi. The analysis samples were selected from the serum of patients who underwent clinical testing in Nanjing Drum Tower Hospital hospital from December 2021 to June 2022. Refer to China′s national health industry standards, China′s national pharmaceutical industry standards, the US Clinical Laboratory Standards Institute (CLSI) for the performance evaluation standards of in vitro diagnostic reagents, and the methods recommended in the relevant regulations of China′s State Food and Drug Administration on the management of in vitro diagnostic reagents. The precision, linear range, open bottle stability, interchangeability of calibrators and accuracy from different batches of 40 reagents were evaluated and validated. Simple linear regression analysis was used for linear regression, and P<0.05 indicated that the regression was statistically significant. Results:The overall precisions of 40 reagents were fine, except for one domestic reagent with low-level intra-batch coefficient of variation ( CV) exceeding the range declared in the specification. The intra-and inter-batch CVs of the remaining reagents were all smaller than those declared in their respective specifications. The linear ranges of domestic reagents and imported ones have achieved the linear ranges declared by each manufacturer. There were no statistical differences on the measurements between the reagents from open bottle of 30 days and the corresponding new ones for 40 reagents( P>0.05). The test values of domestic reagents and imported reagents after exchange of different batches of calibrators were within the ranges declared by each manufacturer. Both domestic reagents and imported reagents have passed the accuracy verification. Conclusions:The performance index of 27 biochemical detection indicators of the three domestic manufacturers are basically consistent with those of imported reagents, meeting the requirements of clinical biochemical laboratories. However, the bottle opening stability and anti-interference performance of some detection reagents needs to be improved.

Effects of different polishing procedures on the surface roughness and hardness of polyether ether ketone (PEEK) / Efecto de diferentes procedimientos de pulido en la rugosidad y dureza de superficie de un material a base de poliéter éter acetona (PEEK)

ABSTRACT: There is insufficient information about the chairside polishing methods of polyether ether ketone material. Therefore, it is aimed in this study to investigate the effects of different polishing processes on polyether ether ketone surface roughness and hardness. A total of 66 disc-shaped specimens made of polyether ether ketone were used in this study. The specimens were polished conventionally and randomly divided into three groups (n=22). One group was designated as the control group, and no further treatment was applied. In the other two groups, the specimens' surfaces were abraded with diamond burs and polished using two different polishing kits. Their surface roughness and Vickers hardness were measured, and environmental scanning electron microscopy and atomic force microscopy examinations were performed. The data were statistically analysed using analysis of variance and Tukey's honest significant difference test (α=0.05). There were no statistically significant differences between the control and polishing kit groups in terms of either surface roughness or Vickers hardness (p>0.05). The polishing kits can be used reliably and effectively for polishing polyether ether ketone materials.

RESUMEN: No existe información suficiente sobre los métodos de pulido del material poliéter éter cetona. Por tanto, este estudio tiene como objetivo evaluar el efecto de diferentes procedimientos de pulido sobre la rugosidad y dureza de superficie de un material a base de poliéter éter acetona. Un total de 66 muestras en forma de disco fueron realizadas. Los especímenes fueron divididos en tres grupos (n=22). Un grupo fue designado como grupo de control, siendo que no se aplicó ningún tratamiento. En los otros dos grupos, las superficies de las muestras se lijaron con fresas de diamante y se pulieron con dos kits de pulido diferentes. Se investigó la rugosidad de superficie y la dureza Vickers en los diferentes grupos. También fueron evaluadas muestras representativas en microscopía electrónica de barrido y microscopía de fuerza atómica. Los datos se analizaron estadísticamente mediante el análisis de varianza (ANOVA) y el método de Tukey (α=0.05). No hubo diferencias estadísticamente significativas entre los grupos en términos de rugosidad de superficie o Dureza Vickers (p>0,05). Los kits de pulido se pueden utilizar de forma eficaz para el pulido de materiales a base de poliéter éter acetona.

Comprehensive performance evaluation of immunocolloidal gold qualitative rapid detection kits based on AHP-FCE method / 上海预防医学

Objective To establish a scientific and objective evaluation model of the comprehensive performance of immunocolloidal gold qualitative rapid detection kits, and to provide a reference for the overall evaluation of similar products. Methods Based on the various factors affecting the performance of qualitative rapid detection kits, a comprehensive performance evaluation index system consisting of 4 first-level indicators and 18 second-level indicators was constructed.The analytic hierarchy process (AHP) and the fuzzy comprehensive evaluation (FCE) method were combined to determine the weights for the evaluation indicators and graded thresholds.The model was then used to evaluate the performance level of 6 brands of furazolidone metabolite rapid test kits. Results According to maximum membership degree principle, the evaluation of brand A, B, C, D, E and F were graded as good, excellent, middle, excellent, middle and excellent, respectively.Then the scores of 6 brands were calculated according to the hundred-mark system, and brand B had the highest score.This was consistent with the actual use experience. Conclusion The application of this model can make the evaluation results more comprehensive and accurate, providing reference for rational evaluation and selection of qualitative rapid detection kits.

Comparison and analysis of the detection performance of six new coronavirus nucleic acid detection reagents / 重庆医学

Objective To compare and analyse the detection performance of different 2019-new coronavirus (2019-nCoV) nucleic acid detection kits, in order to provide references for laboratory. Methods Six kinds of domestic reagents (A—F reagent) were selected for parallel detection of a series of samples from one patient in this hospital whose 2019-nCoV nucleic acid result was confirmed weakly positive. The samples were taken at three different times, the RNAs were extracted and amplified, and two parallel tests were performed each time by use of these six kits. The detection performance was compared according to the results of each kit. Results The three parallel test results (ORF1ab and N gene) of C and F reagents were positive, the results of D reagent showed the N gene was not detected, and the results of A, B, E reagents showed the ORF1ab gene was not detected sometimes. The reproducibility of in-batch detections by C reagent was the best, and the CT values of F reagents (N and ORF1ab), E reagents (ORF1ab) and A reagents (ORF1ab) showed changes in trend. Conclusion There are differences in the detection ability of six 2019-nCoV nucleic acid detection reagents for weakly positive samples, and the accuracy, sensitivity and reproducibility of some reagents are not good. There is an urgent need to further optimize and improve their performance in order to better meet the needs of large-scale screening.

Isolation and properties of lactate dehydrogenase isoenzyme from buffalo liver: Application in AST and ALT assay diagnostic kits

Lactate dehydrogenase (LDH) enzyme is a major component of aspartate aminotransferase (AST) and alanineaminotransferase (ALT) diagnosis kits. In this work, the LDH enzyme was purified and characterized from buffalo liverfor direct application in the preparation of AST and ALT diagnosis kits. One major LDH (BLLDH) isoform and twoother secondary LDH peaks were analyzed for buffalo liver by diethylaminoethyl (DEAE) cellulose chromatography.BLLDH was obtained by ammonium sulfate sedimentation and chromatographically separated on ion exchange andsize-exclusion matrices. The isolated BLLDH has a specific activity of 17.6 units/mg proteins represented 16 foldsand 32% recovery. BLLDH was manifested homogeneous on native and SDS gels with 35 kDa native mass. OptimumpH of BLLDH was displayed at pH 7.6. BLLDH activity was diminished by FeCl2 and SDS. The produced BLLDH isutilized in constructing of AST and ALT diagnosis kits that were sensible and analogous to trade ready kits.

Utility of rapid diagnostic kit tests for diagnosis of suspected dengue fever

Background: Dengue fever often presents as an undifferentiated febrile illness requiring a laboratory test for identification. Serological tests particularly on rapid kits for the detection of NS1Antigen, IgG and IgM antibodies are the most commonly performed test across the country.Methods: The serum samples of suspected dengue cases were tested by Rapid test kits for assessing all the three parameters as well as by ELISA for NS1 antigen test. The platelet count of the patients was obtained from automated coulter counter. The results thus obtained were analyzed in Excel format.Results: The serum samples from 304 suspected Dengue fever cases were received in the lab, of which 190 samples were positive either by rapid or ELISA and 176 when rapid card test was considered alone Highest seropositivity of dengue cases were observed in the age group of ≥60 years (79.2%) followed by 45-59 years (70.7%). On rapid test, 78 cases were NS1 antigen positive of which 60 cases were positive only for NS1 antigen. When NS1 rapid and ELISA tests when compared, 16 kit negative tests were positive on ELISA while 34 kit positive tests were ELISA negative.  Sensitivity, specificity, PPV and NPV when only NS1 was considered on rapid test kits when compared with ELISA were 78.9%, 87.8%, 63.8% and 93.8%. 33.5% of serologically positive cases of Dengue had low platelet count on admission while only among negative cases 17.2% had a low platelet.Conclusions: Rapid kits often show variable results thus needing a validation of them from end user. As a positive dengue test result is an essential prerequisite for diagnosis thus it is essential that for serological tests ELISA technique should be used for reporting. Thus, it also mandates more efforts at decentralization of NVBDCP to include both government and non government institutions.

Availability of AFP Specimen Collection Kits and Data Tools in Health Facilities in Selected States in Nigeria

Background: Acute flaccid paralysis (AFP) surveillance was adopted globally as a key strategy for monitoring the progress of the polio eradication initiative. The main objective of AFP surveillance is to detect the presence of circulating wild-type poliovirus and other subtypes of polioviruses. Stool specimen collection kits for AFP surveillance and data tools, regrettably are not always available in health facilities, and thus cause gaps in specimen collection and proper documentation which could ultimately lead to under-reporting of cases. Methods: This survey was undertaken to determine the availability of stool collection kits and data capturing tools in health facilities in some randomly selected states in Nigeria. The main aim was to relate the findings with the quality of the surveillance system in the areas visited and an overall indication of the functionality of the process in the country. Results: The outcome of the study found only 32,598 (74.7%) health facilities out of the 43,644 health facilities who visited and had stool specimen collection kits, while of the 43,582 health facilities visited, only 38,029 (87.3%) health facilities had data tools. Conclusions: Gaps were noticed in the supply of key AFP surveillance components to the health facilities visited, which by extension could apply to those not visited. Countries that are still polio-endemic will have to regularly survey their facilities for the availability of these very important materials. The methodology can be adapted to other diseases to evaluate the strength of the surveillance system.

Usefulness of Carbohydrate Antigen 19-9 Test in Healthy People and Necessity of Medical Follow-up in Individuals with Elevated Carbohydrate Antigen 19-9 Level / 가정의학회지

BACKGROUND: Carbohydrate antigen 19-9 (CA 19-9) is a tumor marker whose level is elevated in many types of cancers and other benign conditions. CA 19-9 levels are frequently found to be elevated in individuals during general health examinations. This study aimed to investigate the clinical characteristics of such individuals and to determine the need for medical follow-up. METHODS: We investigated individuals who underwent a health inspection, including a serum CA 19-9 test, at our center. Their CA 19-9 levels, age, sex, body mass index (BMI), and personal and past histories were investigated. Additionally, subgroup analyses were performed for those who underwent follow-up study for the elevated CA 19-9 levels. RESULTS: Of 58,498 subjects, 581 (1.0%) had elevated CA 19-9 levels. Multivariate analyses revealed that older age, female sex, lower BMI, and diabetes were independent predisposing factors for elevated CA 19-9 level. A subgroup analysis revealed that the causative conditions were identified in 129 of 351 subjects (36.8%). Among them, the causative conditions in 31 subjects (8.8%, including four cases of cancer and 15 of benign tumors) were not detected at the initial check-up and were found during the follow-up period. CONCLUSION: The use of CA 19-9 as a marker for cancer in healthy individuals is inappropriate. However, medical follow-up in individuals with elevated CA 19-9 levels may be useful because some causative diseases may be detected during follow-up.

Application of miniSTR Loci and Its Detection System for Degraded Materials in Forensic Medicine / 法医学杂志

OBJECTIVES@#To establish multiplex system of 16 miniSTR loci, and explore its application value for the degraded materials in forensic medicine.@*METHODS@#The multiplex system of 16 miniSTR loci was established using a six-dye fluorescence labeling technology and its application value in forensic medicine was assessed.@*RESULTS@#A six-dye fluorescence labeling miniSTR amplification kit was developed, which enabled 15 autosomal STR loci, Amelogenin locus and DYS391 to be typed simultaneously. This method showed good specificity and could provide stable and accurate typing results with a sensitivity of 50 pg. This system also provided a good test result for the normal biological sample of actual cases.@*CONCLUSIONS@#The multiplex system of 16 miniSTR loci has application value for degraded and trace materials with the advantages of high sensitivity and database compatibility, which can be used for forensic casework.

Evaluation of three commercially-available chikungunya virus immunoglobulin G immunoassays / Evaluación de tres inmunoensayos comercializados de inmunoglobulina G para el diagnóstico del virus del chikungunya

ABSTRACT The emergence of chikungunya virus in the Americas means the affected population is at risk of developing severe, chronic, rheumatologic disease, even months after acute infection. Accurate diagnostic methods for past infections are essential for differential diagnosis and consequence management. This study evaluated three commercially-available chikungunya Immunoglobulin G immunoassays by comparing them to an in-house Enzyme-Linked ImmunoSorbent Assay conducted by the Centers for Disease Control and Prevention (Atlanta, Georgia, United States). Results showed sensitivity and specificity values ranging from 92.8% - 100% and 81.8% - 90.9%, respectively, with a significant number of false-positives ranging from 12.5% - 22%. These findings demonstrate the importance of evaluating commercial kits, especially regarding emerging infectious diseases whose medium and long-term impact on the population is unclear.(AU)

RESUMEN Como consecuencia de la aparición del virus del chikungunya en las Américas, la población afectada corre el riesgo de padecer reumatismos crónicos graves, aun meses después de la infección aguda. Es fundamental contar con métodos precisos para diagnosticar los antecedentes de la infección a fin de elaborar un diagnóstico diferencial y abordar las manifestaciones de la fase crónica. Se han estudiado tres inmunoensayos comercializados de detección de inmunoglobulinas G para el diagnóstico del chikungunya, comparándolos con el enzimoinmunoanálisis de adsorción (ELISA) propio. Los resultados señalan valores de sensibilidad del 92,8% al 100% y de especificidad del 81,8% al 90,9%, así como un número significativo de falsos positivos, de entre el 12,5% y el 22%.(AU)

Serum small dense low-density lipoprotein cholesterol and performance evaluation of commercial detection kits and its relationship with the severity of coronary heart disease / 中华检验医学杂志

Objective To evaluate the performance of serum small dense low-density lipoprotein cholesterol(sdLDL-C)kit using enzymic method and evaluate the relationship with the severity of coronary heart disease.Methods Performance verification methodology. The analytical performance consisted of accuracy, precision and linearity of serum sdLDL-C kit using enzymic method was assessed. One hundred and twenty healthy persons were recruited to establish serum sdLDL-C reference interval. Two hundred and twelve patients underwent coronary angiography were enrolled in the study.Among them 110 cases were positive for coronary angiography, where as 102 cases were negative. We examined serum levels of sdLDL-C in 110 patients with positive angiography, 102 patients with negative angiography and 120 healthy volunteers. Positive group was classfied into severe group(Gensini score>30) and mild group (Gensini score≤30).Results The accuracy and precision of sdLDL-C examination were in compliance with manufacturer′s statement and there was a good linear correlation(Y=0.9937X-0.1063,R2=0.99) in range of 0.06-2.45 mmol/L. The reference interval of sdLDL-C was 0.15-0.97 mmol/L and without gender and age specificity. The level of sdLDL-C was higher in positive angiography group than in negative angiography group and healthy control group(P<0.01). The level of sdLDL-C was higher in severe group than in mild group(P<0.05). Binary stepwise regression analysis demonstrated that sdLDL-C was independently associated with the severity of coronary heart disease(OR=3.101,P<0.05).ConclusionsExperiment data demonstrated that serum sdLDL-C kit using enzymic method has good performance in the accuracy, precision and linearity. SdLDL-C that plays an important role in the occurrence and progression of coronary heart disease, is an independent important risk of the severity of coronary heart disease.

Evaluation of a novel small dense low-density lipoprotein cholesterol kit and investigate the clinical value in the population of coronary heart disease / 中华检验医学杂志

Objective To evaluate the performance of serum small dense low-density lipoprotein cholesterol(sdLDL-C) kit using enzymic method and investigate the clinical value in coronary heart disease (CHD).Methods According to the standard of Clinical and Laboratory Standards Institute (CLSI),evaluae the precision,linearity ranges,reportable range and accuracy of sdLDL-C kit.The 683 patients with coronary heart disease (CHD,423 men and 260 women,age 35-79 years) who were diagnosed at the people's hospital of Peking university from October 2015 to October 2016 were divided into two groups.The treated group include 571 patients(CHD1,342 men and 229 women,age 40-79 years) which taking lipidlowering drugs and the other include 112 cases (CHD2,81 men and 31 women,age 35-70 years)without Lipid-lowing treatment.Besides,the Control group contains 472 healthy persons (274 men and 198 women,age 41-75 years),were collected from the people's hospital of Peking university between April and August 2016.The liver function,renal function,blood glucose and blood lipid in CHD group(CHD1,CHD2) and healthy control group were detected.The new enzyme assay kit was used for the determination of sdLDL-C.The data of normal distribution were compared by independent t test between the two groups.The Mann-Whitney U nonparametric test was used for comparison between two groups.Results The precision of sdLDL-C kit examination was in compliance with manufacturer'statement.The linearity was good in 0.11-2.42 mmol/L(Y =1.008 9X + 0.024 8,R2 =0.998 2),the scope of the report is 0.11-4.84 mmol/L.The level of sdLDL-C in CHD group was significantly higher than that in healthy control group,it has a statistical significance[0.824 (0.443) mmol/L,0.609 (0.361) mmol/L;Z =-5.603,P ＜ 0.001].The level of sdLDL-C in (CHD 1) was lower than (CHD 2) [0.761 (0.479) mmol/L,0.888(0.426) mmol/L;Z=-2.304,P＜ 0.021].After additional adjustment for various tradition cardiovascular risk factor,including ages,sex,CHO,TG,Hs-CRP,Lp(a),and GLU,the highest quartile of sdLDL-C comparison to the bottom quartile,the OR was 3.02,(95％ CI,1.15-9.05) for CHD.Conclusions Experiment data demonstrated that sdLDL-C kit using enzymic method has good performance in the precision,linearity ranges,reportable range and accuracy,sdLDL-C serum level was significantly higher in CHD group.

Definitive tests for dengue fever: when and which should I use?

Dengue is a mosquito-borne viral disease that has established itself globally in both endemic and epidemic transmission cycles. While diagnostic decision-making for dengue is often guided by clinical judgement, definitive laboratory tests, including rapid point-of-care tests, have many advantages in the primary care setting. These include providing epidemiological data and diagnostic clarity for atypical cases, as well as contributing to patient education and compliance. This article discussed the types of diagnostic methods for dengue, when to use them and the appropriateness of each test. Viral detection diagnostic methods such as NS1 antigen assays are generally used within the first week of illness onset, whereas dengue serology testing is most appropriate after that time frame. Locally available rapid point-of-care tests, which include both assays in one convenient test kit, can enhance dengue diagnosis in an endemic setting.

Development of surgical first aid kits of for combat readiness / 局解手术学杂志

Objective To develop new surgical first aid kits for combat readiness ,and increase the ability of field first aid .Methods On the basis of disposable surgical kits ,the surgical towels were improved .The water absorbing layer was made of SPA materials which inte-grated optimization for surgical use .Results The new surgical first aid kits for combat readiness have the surgical towels with strong water absorption,complete sterile materials,and short time for ready of supplies.Conclusion The new surgical first aid kits for combat readiness have the advantages of small volume ,practicability,available for surgery ,at the same time,which could keep the surgical incision dry and the temperature of patients stability and be helpful to decrease the risk of pressure ulcer and infection ,simplify work procedure .

Analytical and Clinical Validation of Six Commercial Middle East Respiratory Syndrome Coronavirus RNA Detection Kits Based on Real-Time Reverse-Transcription PCR

BACKGROUND: During the 2015 outbreak of Middle East Respiratory Syndrome coronavirus (MERS-CoV), six different commercial MERS-CoV RNA detection kits based on real-time reverse-transcription polymerase chain reaction (rRT-PCR) were available in Korea. We performed analytical and clinical validations of these kits. METHODS: PowerChek (Kogene Biotech, Korea), DiaPlexQ (SolGent, Korea), Anyplex (Seegene, Korea), AccuPower (Bioneer, Korea), LightMix (Roche Molecular Diagnostics, Switzerland), and UltraFast kits (Nanobiosys, Korea) were evaluated. Limits of detection (LOD) with 95% probability values were estimated by testing 16 replicates of upstream of the envelope gene (upE) and open reading frame 1a (ORF1a) RNA transcripts. Specificity was estimated by using 28 nasopharyngeal swabs that were positive for other respiratory viruses. Clinical sensitivity was evaluated by using 18 lower respiratory specimens. The sensitivity test panel and the high inhibition panel were composed of nine specimens each, including eight and six specimens that were positive for MERS-CoV, respectively. RESULTS: The LODs for upE ranged from 21.88 to 263.03 copies/reaction, and those for ORF1a ranged from 6.92 to 128.82 copies/reaction. No cross-reactivity with other respiratory viruses was found. All six kits correctly identified 8 of 8 (100%) positive clinical specimens. Based on results from the high inhibition panel, PowerChek and AccuPower were the least sensitive to the presence of PCR inhibition. CONCLUSIONS: The overall sensitivity and specificity of all six assay systems were sufficient for diagnosing MERS-CoV infection. However, the analytical sensitivity and detection ability in specimens with PCR inhibition could be improved with the use of appropriate internal controls.

Efficacy comparative of different laboratory test reagents for hepatitis C virus antibody / 临床肝胆病杂志

ObjectiveTo investigate the effects of different laboratory test reagents for hepatitis C virus (HCV) antibody through a comparative analysis. MethodsA total of 207 samples which tested positive by four anti-HCV screening reagents commonly used in the laboratories in China (Kehua, Xinchuang, Wantai, and Abbott) were included. HCV RNA nucleic acid amplification (NAT) was performed, and if NAT results were negative, recombinant immunoblot assay (RIBA) was performed for further confirmation. The test results of these four screening reagents were compared, and their S/CO values and true positive rates were analyzed. ResultsOf all the 205 samples testing positive by any one reagent, 191 (93.2%) tested positive by the four reagents, and 14 (6.8%) were tested inconsistently by the four reagents. The positive predictive values of Xinchuang, Kehua, Wantai, and Abbott reagents were 88.2% (180/204), 93.8% (180/192), 91.4% (180/197), and 90.0% (180/200), respectively. The S/CO thresholds with a positive predictive value of ≥95% for Xinchuang, Kehua, Wantai, and Abbott reagents were 9.0, 4.0, 5.0, and 7.0, respectively. ConclusionXinchuang, Kehua, Wantai, and Abbott reagents have significantly different S/CO thresholds with a positive predictive value of ≥95%, which are significantly different from those in other domestic laboratories. Each laboratory should establish an applicable S/CO threshold with a positive predictive value of ≥95%, in order to reduce the sample size for confirmatory test.