scholarly journals Evaluation of Six Commercial Point-of-Care Tests for Diagnosis of Acute Dengue Infections: the Need for Combining NS1 Antigen and IgM/IgG Antibody Detection To Achieve Acceptable Levels of Accuracy

2011 ◽  
Vol 18 (12) ◽  
pp. 2095-2101 ◽  
Author(s):  
Stuart D. Blacksell ◽  
Richard G. Jarman ◽  
Mark S. Bailey ◽  
Ampai Tanganuchitcharnchai ◽  
Kemajittra Jenjaroen ◽  
...  

ABSTRACTSix assays were evaluated in this study to determine their suitability for the diagnosis of acute dengue infection using samples from 259 Sri Lankan patients with acute fevers (99 confirmed dengue cases and 160 patients with other confirmed acute febrile illnesses): (i) the Merlin dengue fever IgG & IgM combo device (Merlin), (ii) the Standard Diagnostics Dengue Duo nonstructural 1 (NS1) antigen and IgG/IgM combo device (Standard Diagnostics, South Korea), (iii) the Biosynex Immunoquick dengue fever IgG and IgM (Biosynex, France) assay, (iv) the Bio-Rad NS1 antigen strip (Bio-Rad, France), (v) the Panbio Dengue Duo IgG/IgM Cassette (Inverness, Australia), and (vi) the Panbio dengue NS1 antigen strip (Inverness, Australia). The median number of days of fever prior to admission sample collection was 5 days (interquartile range, 3 to 7 days). Sensitivity and specificity of the NS1 antigen tests ranged from 49 to 59% and from 93 to 99%, respectively, and sensitivity and sensitivity of the IgM antibody test ranged from 71 to 80% and from 46 to 90%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics Dengue Duo test gave the best compromise of sensitivity and specificity (93% and 89%, respectively) and provided the best sensitivity in patients presenting at different times after fever onset. The Merlin IgM/IgG antibody tests correctly classified 64% and 86% of the primary and secondary dengue infection cases, respectively, and the Standard Diagnostics IgM/IgG antibody tests correctly classified 71% and 83% of the primary and secondary dengue infection cases, respectively. This study provides strong evidence of the value of combining dengue antigen- and antibody-based test results in the rapid diagnostic test (RDT) format for the acute diagnosis of dengue.

Author(s):  
Dr. Tanajee Zade ◽  
Dr. K. Srinivas ◽  
Dr. Akshay Berad

Dengue fever is an acute febrile arboviral disease affecting tropical & subtropical regions of the world. Dengue infection produces a spectrum of clinical illness, ranging from an asymptomatic to its most severe form like dengue haemorrhagic fever and dengue shock syndrome. In view of high morbidity and mortality, it is imperative to have a rapid and sensitive laboratory assay for early detection of the dengue infection. The newer parameter NS1 antigen has gained a lot of interest for early diagnosis of the disease. Detection of non-structural antigen (NS1 Ag), IgM and IgG antibody may help in the early diagnosis. The present study was conducted in a RIMS Adilabad, tertiary care hospital & medical college in the Department of  General Medicine. A total of 100 serum samples were processed from suspected cases of dengue fever by using dengue test for detection of NS1 antigen and IgG antibodies. Platelet counts of all these cases were noted. . Of these 100 subjects 85 were serologically proved to have dengue illness, 57 patients were NS1 antigen positive, 28 patients were IgM antibody positive patients. As the NS1 antigen is detectable in blood from day one after onset of fever, its assay is an effective tool for early diagnosis of dengue infection so as to avoid complications. Key words:  Dengue, NS1 Antigen, IgM antibody, Platelet


Diagnostics ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1441
Author(s):  
Suelen Basgalupp ◽  
Giovana dos Santos ◽  
Marina Bessel ◽  
Lara Garcia ◽  
Ana Carolina de Moura ◽  
...  

Serological assays emerged as complementary tools to RT-PCR in the diagnosis of SARS-CoV-2 as well as being needed for epidemiological studies. This study aimed to assess the performance of a rapid test (RT) compared to that of serological tests using finger prick blood samples. A total of 183 samples were evaluated, 88 of which were collected from individuals with negative RT-PCR and 95 from positive RT-PCR individuals. The diagnostic performance of RT (WONDFO®) and LUMIT (PROMEGA®) were compared to that of ELISA (EUROIMMUN®) for detecting antibodies against SARS-CoV-2 according to time from symptoms onset. The IgG antibody tests were detected in 77.4% (LUMIT), 77.9% (RT), and 80.0% (ELISA) of individuals. The detection of antibodies against SARS-CoV-2 increases in accordance with increasing time from symptoms onset. Considering only time from symptoms onset >21 days, the positivity rate ranged from 81.8 to 97.0% between the three tests. The RT and LUMIT showed high agreement with ELISA (agreement = 91.5%, k = 0.83, and agreement = 96.3%, k = 0.9, respectively) in individuals who had symptoms 15 to 21 days before sample collection. Compared to that of the ELISA assay, our results show sensitivity ranged from 95% to 100% for IgG antibody detection in individuals with symptoms onset between 15 and 21 days before sample collection. The specificity was 100% in individuals with symptoms onset >15 days before serological tests. This study shows good performance and high level of agreement of three immunoassays for the detection of SARS-CoV-2 antibodies.


Author(s):  
F. Sneha Kukanur ◽  
G. Naveen ◽  
N. Ashwin Chitrabanu ◽  
B.M. Prashant ◽  
R. Meghana ◽  
...  

Dengue viral infection is the most widely spread arbo-viral disease in Indian subcontinent. High index of clinical suspicion especially during its peak season can be rewarding in diagnosing as well as early case management of anticipated DHF and DSS cases. To estimate the magnitude, seasonal-variation, serological as well as hematological aspects of dengue cases. This was a prospective observational study held in Microbiology and Hematology laboratories of our hospital for duration of one year from July-2019 to June-2020. All the suspected dengue cases were subjected to NS1-antigen, IgM and IgG antibody detection. The samples were also tested for platelet count, total count, haematocrit as well as hemoglobin estimation. All 1,550 dengue suspected cases were subjected to serological testing, among which 157 (10.1%) were positive. The most affected populations were the adult male. As the study was conducted for one year, we could observe the seasonal trend which peaked during post-monsoon. Out of 157 cases, 81.5%, 0.6% and 17.8% were determined as primary, secondary and old dengue cases respectively. There was a significant association between NS1 antigen and fever of </= 5 days duration with ‘p’ value< 0.00001. Thrombocytopenia, leucopenia and increased haematocrit were witnessed in 15.9%, 28.6% and 35% respectively. Our study shows that we had a high magnitude of primary cases that are prone to secondary dengue infection which might have a catastrophic effect giving rise to DHF, DSS or SD.


2012 ◽  
Vol 19 (5) ◽  
pp. 804-810 ◽  
Author(s):  
Stuart D. Blacksell ◽  
Richard G. Jarman ◽  
Robert V. Gibbons ◽  
Ampai Tanganuchitcharnchai ◽  
Mammen P. Mammen ◽  
...  

ABSTRACTSeven commercial assays were evaluated to determine their suitability for the diagnosis of acute dengue infection: (i) the Panbio dengue virus Pan-E NS1 early enzyme-linked immunosorbent assay (ELISA), second generation (Alere, Australia); (ii) the Panbio dengue virus IgM capture ELISA (Alere, Australia); (iii) the Panbio dengue virus IgG capture ELISA (Alere, Australia); (iv) the Standard Diagnostics dengue virus NS1 antigen ELISA (Standard Diagnostics, South Korea); (v) the Standard Diagnostics dengue virus IgM ELISA (Standard Diagnostics, South Korea); (vi) the Standard Diagnostics dengue virus IgG ELISA (Standard Diagnostics, South Korea); and (vii) the Platelia NS1 antigen ELISA (Bio-Rad, France). Samples from 239 Thai patients confirmed to be dengue virus positive and 98 Sri Lankan patients negative for dengue virus infection were tested. The sensitivities and specificities of the NS1 antigen ELISAs ranged from 45 to 57% and 93 to 100% and those of the IgM antibody ELISAs ranged from 85 to 89% and 88 to 100%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics ELISAs gave the best compromise between sensitivity and specificity (87 and 96%, respectively), as well as providing the best sensitivity for patients presenting at different times after fever onset. The Panbio IgG capture ELISA correctly classified 67% of secondary dengue infection cases. This study provides strong evidence of the value of combining dengue virus antigen- and antibody-based test results in the ELISA format for the diagnosis of acute dengue infection.


Author(s):  
Yafang Wan ◽  
Zhijie Li ◽  
Kun Wang ◽  
Tian Li ◽  
Pu Liao

Objectives The purpose of the current study was to evaluate the analytical performance of seven kits for detecting IgM/IgG antibodies against coronavirus (SARS-CoV-2) by using four chemiluminescence immunoassay systems. Methods Fifty patients diagnosed with SARS-CoV-2 infection and 130 controls without coronavirus infection from the General Hospital of Chongqing were enrolled in the current retrospective study. Four chemiluminescence immunoassay systems, including seven IgM/IgG antibody detection kits for SARS-CoV-2 (A_IgM, A_IgG, B_IgM, B_IgG, C_IgM, C_IgG and D_Ab), were employed to detect antibody concentrations. The chi-square test, the receiver operating characteristic (ROC) curve and Youden’s index were determined to verify the cut-off value of each detection system. Results The repeatability verification results of the A, B, C and D systems are all qualified. D_Ab performed best (92% sensitivity and 99.23% specificity), and B_IgM performed worse than the other systems. Except for the A_IgM and C_IgG systems, the optimal diagnostic thresholds and cut-off values of the other kits and their recommendations are inconsistent with each other. B_IgM had the worst AUC, and C_IgG had the best diagnostic accuracy. More importantly, the B_IgG system had the highest false-positive rate for testing patients with AIDS, tumours and pregnancies. The A_IgM system test showed the highest false-positive rates among elderly individuals over 90 years old. COVID-2019 IgM/IgG antibody test systems exhibit performance differences. Conclusions The Innodx Biotech Total Antibody serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used together with nucleic acid tests as an alternative method for SARS-CoV-2 detecting.


2020 ◽  
Author(s):  
Qihong Yu ◽  
Jingdong He ◽  
Bin Xing ◽  
Xin Li ◽  
Hongyu Qian ◽  
...  

Abstract Background: At present, serum Aspergillus IgG and IgM antibody detection is mainly used in the diagnosis of chronic pulmonary aspergillosis (CPA), but its value in the diagnosis of invasive pulmonary aspergillosis (IPA) in non-agranulocytic patients is still unclear. IgG is a marker of long-term infection and is used to assist in the diagnosis of pre-existing or chronic infection-related diseases. The aim of this study was to investigate and compare the value of serum Aspergillus IgG and IgM antibody detection in the diagnosis of IPA and CPA in non-agranulocytic patients. Methods: Fifty-eight cases of pulmonary aspergillosis (37 IPA and 21 CPA cases), 15 cases of community-acquired bacterial pneumonia and 50 cases in the healthy control group were collected. The serum (1,3)-β-D-glucan test (G test) was performed with a chromogenic method, and the galactomannan test (GM test) and Aspergillus IgG and IgM antibody detection were performed by commercial enzyme-linked immunosorbent assay (ELISA) in all patients. The sensitivity and specificity, cut-off value and area under the curve (AUC) of Aspergillus IgG and IgM antibodies were further obtained by receiver operating characteristic (ROC) curves. Results: The positive rate of the G test, Aspergillus IgG antibody detection and the GM test also showed notable differences among the IPA, CPA, community-acquired bacterial pneumonia and healthy groups ( P = 0.006, P < 0.001 and P = 0.217, respectively). Only the positive rate of the GM test showed a significant difference between the IPA and CPA groups ( P = 0.04). ROC curves indicated that Aspergillus IgG antibody detection had a higher specificity in the IPA group than in the CPA group (0.952). The detection of Aspergillus IgG antibody can preferably distinguish IPA from community-acquired bacterial pneumonia and healthy controls (sensitivity = 0.923, specificity = 0.459, cut-off value = 134.46, AUC = 0.727). It can also distinguish CPA from community-acquired bacterial pneumonia and healthy controls (sensitivity = 0.952, specificity = 0.692, cut-off value = 75.46, AUC = 0.873). Conclusions: Serum Aspergillus IgG antibody detection may have certain clinical value in the diagnosis of IPA and CPA in non-agranulocytic patients.


2013 ◽  
Vol 3 (1) ◽  
Author(s):  
Mayer F. Wowor

Abstract: Efficient and accurate diagnosis of dengue is of primary importance for clinical care, surveillance activities, outbreak control, pathogenesis, academic research, vaccine development, and clinical trials. Laboratory diagnostic methods for confirming dengue virus infection may involve detection of the viruses, viral nucleic acids, antigens and antibodies, or a combination of these techniques. After the onset of illness, the virus can be detected in serum, plasma, circulating blood cells, and other tissues for 4–5 days. During the early stage of the disease, virus isolation and the detection of viral nucleic acids or antigens, can be used to confirm the diagnosis of dengue infection. NS1 antigen appears as early as day 1 after the onset of fever, and declines to undetectable levels after day 5–6. At the end of the acute phase of infection, a serological test is the method of choice for diagnosis. A range of laboratory diagnostic methods has been developed to support patient management and disease control. The choice of diagnostic method depends on the purpose for which the test is done, available  laboratory facilities and technical expertise, costs, and the time of sample collection. Keywords: laboratory diagnostic methods, acute phase, NS1 antigen     Abstrak: Diagnosis dengue yang efisien dan akurat adalah hal yang paling penting  untuk proses perawatan di klinik, aktivitas surveilens, kontrol penularan penyakit, patogenesis, penelitian akademik, pengembangan vaksin dan percobaan-percobaan klinis. Metode diagnosis laboratorium untuk mengonfirmasi adanya infeksi virus dengue dapat meliputi deteksi virus dengue, asam nukleat virus, antigen dan antibodi, atau kombinasi dari teknik-teknik tersebut. Setelah serangan penyakit, virus dapat dideteksi dalam serum, plasma, sel-sel darah yang bersirkulasi, dan di jaringan lain dalam waktu 4-5 hari. Selama tahap awal dari penyakit, isolasi virus, asam nukleat virus, atau deteksi antigen dapat digunakan untuk diagnosis infeksi. Antigen NS1 muncul pada hari pertama setelah serangan demam dan menurun ke tingkat tidak terdeteksi setelah 5-6 hari. Pada akhir fase akut infeksi, serologi adalah metode pilihan untuk diagnosis. Metode diagnosis laboratorium telah berkembang untuk menunjang penanganan pasien dan kontrol penyakit. Pilihan untuk metode diagnosis bergantung pada tujuan tes dilakukan, fasilitas laboratorium dan tenaga ahli yang tersedia, biaya, dan saat sampel dikumpulkan. Kata kunci: metode diagnosis laboratorium, fase akut, antigen NS1


2021 ◽  
Vol 15 ◽  
Author(s):  
Xiaoqian Guo ◽  
Lisha Tang ◽  
Qianyi Huang ◽  
Xiangqi Tang

Objectives: To review the available evidence on sensitivity and specificity of anti-NF155 antibody detection in diagnosing a specific subset of patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and to calculate the frequencies of different autoantibodies to paranodal proteins.Background: Diagnosis of CIDP relies on clinical and neurophysiologic criteria and lacks useful diagnostic biomarkers. A subset of CIDP patients exhibit atypical clinical phenotypes and impaired response to conventional treatments. These patients were reported as having autoantibodies targeting paranodal protein neurofascin isoform 155 (NF155), contactin-1 (CNTN1), and contactin-associated protein-1 (CASPR1). Here, we conducted a meta-analysis to summarize evidence on the diagnostic and prognostic value of these autoantibodies, especially for anti-NF155 antibody.Methods: We searched the following electronic bibliographic databases: PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science. Eligible studies provided information to calculate the frequencies of anti-NF155 antibody and anti-CNTN1 antibody, the sensitivity and specificity of anti-NF155 antibody, and the incidence of improvement and deterioration among anti-NF155 antibody seropositive CIDP patients. Heterogeneity was assessed using Q and I2 statistics.Results: The pooled frequency of anti-NF155 autoantibody across 14 studies was 7% [95% confidence interval (CI): 0.05–0.10] with high heterogeneity; the overall pooled sensitivity and specificity of anti-NF155 antibody for the diagnosis of a specific subgroup of CIDP patients were 0.45 (95% CI: 0.29–0.63) and 0.93 (95% CI: 0.86–0.97), respectively.Conclusions: For diagnosing of a specific subset of CIDP characterized by poor response to intravenous immunoglobulin (IVIg), we found a moderate sensitivity and a high specificity. The anti-NF155 antibody test should be used as a confirmatory test rather than a screening test.Systematic Review Registration: PROSPERO, identifier: CRD42020203385 and CRD42020190789.


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