Diagnostic Test
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Shirli Israeli ◽  
Allison Golden ◽  
Melissa Atalig ◽  
Najla Mekki ◽  
Afef Rais ◽  

Abstract Purpose No rapid diagnostic test exists to screen individuals for primary antibody deficiencies (PAD) at or near the point of care. In settings at risk for polio where live oral polio vaccine is utilized, undiagnosed PAD patients and cases with delayed diagnosis constitute a potential reservoir for neurovirulent polioviruses, undermining polio eradication. This research aimed to develop a rapid screening test suited for use in resource-limited settings to identify individuals with low immunoglobulin G (IgG) levels, enabling early diagnosis and appropriate treatment. Methods Three prototype tests distinguishing low and normal IgG levels were evaluated with a blinded panel of serum/plasma specimens from 32 healthy controls and 86 primary immunodeficiency-confirmed patients with agammaglobulinemia, common variable immunodeficiency, and hyper-IgM syndrome, including 57 not receiving IgG therapy. Prototype tests were compared to laboratory reference and clinical case definition. Results The leading prototype correctly identified 32 of 32 healthy controls. Among primary antibody deficiency patients not receiving IgG treatment, 17 of 19 agammaglobulinemia, 7 of 24 common variable immunodeficiency, and 5 of 14 hyper-IgM were correctly identified by the prototype, with 67% agreement with the reference assay. Conclusion The Rapid IgG Screen (RIgGS) test can differentiate between low IgG levels associated with agammaglobulinemia and normal IgG antibody levels. Differentiating CVID and hyper IgM was challenging due to the wide range in IgG levels and influence of high IgM. This test can facilitate the identification of patients with primary antibody deficiencies and support polio surveillance initiatives.

2021 ◽  
Vol 67 (3) ◽  
pp. 129-132
Huiping Zhu ◽  
Jianjun Dong ◽  
Xufeng Xie ◽  
Lei Wang

Lobar pneumonia is an inflammatory condition of the lung that mainly affects the lobes of the lungs and the alveoli, and it is usually caused by a bacterial infection. There are many ways to diagnosis this disease. But an early and accurate method for lobar pneumonia diagnosis has an important role in its treatment. Therefore, in this study, a comparison between the molecular diagnostic test and chest x-ray combined with multi-slice spiral CT was done to find out better diagnosis of lobar pneumonia. For this purpose, 122 individuals suspected of lobar pneumonia were studied by clinical examination, chest X-ray, and multi-slice spiral CT. For the molecular diagnosis test, the multiplex PCR was used for two main causes of the disease, Streptococcus pneumoniae and Klebsiella pneumoniae. Results showed that the specificity for Chest X-ray + Multi-slice Spiral CT had the highest amount (82.8%), but high sensitivity (100%) belonged to a molecular diagnostic test for both bacteria. On the other hand, the sensitivity and specificity of Streptococcus pneumoniae were better than Klebsiella pneumoniae and the possibility of error in Streptococcus pneumoniae was lower than Klebsiella pneumoniae. In general, although the Chest X-ray + Multi-slice Spiral CT method was better than the molecular diagnosis test, it could not identify the causative agent and did not show a difference between pathogens for better antibiotic treatment, and also the possibility of diagnosis is low at the beginning of the disease. Therefore, according to the results of the current study, the best way to diagnose lobar pneumonia is to use both methods, simultaneously.

2021 ◽  
Martin Skarzynski ◽  
Erin M McAuley ◽  
Ezekiel J Maier ◽  
Anthony C Fries ◽  
Jameson D Voss ◽  

The 2019 coronavirus disease (COVID-19) pandemic has demonstrated the importance of predicting, identifying, and tracking mutations throughout a pandemic event. As the COVID-19 global pandemic surpassed one year, several variants had emerged resulting in increased severity and transmissibility. In order to reduce the impact on human life, it is critical to rapidly identify which genetic variants result in increased virulence or transmission. To address the former, we evaluated if a genome-based predictive algorithm designed to predict clinical severity could predict polymerase chain reaction (PCR) results, as a surrogate for viral load and severity. Using a previously published algorithm, we compared the viral genome-based severity predictions to clinically-derived PCR-based viral load of 716 viral genomes. For those samples predicted to be severe (predicted severity score > 0.5), we observed an average cycle threshold (Ct) of 18.3, whereas those in in the mild category (severity prediction < 0.5) had an average Ct of 20.4 (P = 0.0017). We found a non-trivial correlation between predicted severity probability and cycle threshold (r = -0.199). Additionally, when divided into quartiles by prediction severity probability, the most probable quartile (≥75% probability) had a Ct of 16.6 (n=10) as compared to those least probable to be severe (<25%) of 21.4 (n=350) (P = 0.0045). Taken together, our results suggest that the severity predicted by a genome-based algorithm can be related to the metrics from the clinical diagnostic test, and that relative severity may be inferred from diagnostic values.

2021 ◽  
Vol 16 (4) ◽  
Adel Zeinalpour ◽  
Maryam Abbasi ◽  
Faezeh Shams ◽  
Barmak Gholizadeh

Introduction: A newly appeared challenge for the healthcare system is the variety of clinical symptoms of COVID-19. In this research, we report 2 cases admitted to Modarres Hospital with unusual postoperative anastomotic failure. Case Presentation: In a 72-year-old man with a perforated peptic ulcer in D2 and signs of leakage after the first operation and during the second operation due to massive unexpected hemorrhage, we found fully disrupted anastomosis on the second part of the duodenum. Accordingly, the suture ligature of the bleeding ulcer with the closure of the duodenal stump and loop gastrojejunostomy and tube duodenostomy were performed. During the postoperative period, he developed dyspnea, and the diagnostic test of SARS-CoV-2 confirmed him as a case of COVID-19. Unfortunately, 1 week after the second surgery, evidence of anastomotic leakage appeared again by bile discharge from drains; although it was managed conservatively, he died because of respiratory failure. In another case, a 65-year-old woman was admitted to the emergency ward with closed-loop small bowel obstruction. After emergency laparotomy, resection of ischemic bowel with primary anastomosis was performed. The same as the previous case, she developed dyspnea, and the diagnostic test resulted positive for COVID-19. After 2 weeks, she was admitted to the hospital with signs of anastomotic leakage that was subsequently confirmed by abdominal computed tomography (CT); although it was managed conservatively, she died because of respiratory failure due to COVID-19. Conclusions: These cases were unique in that intestinal microangiopathies can cause very severe problems, weaken the body, and eventually death, as we have seen in these 2 cases.

2021 ◽  
pp. 1353
Hamzah Haikal Riziq Alwi Alatas ◽  
Ferdinand Nicholas ◽  
Maria Cecilia Nugroho ◽  
Imelda Imelda Martinelli

The significant increase in the number of Covid-19 cases from December 2020 to June 2021 has forced Indonesia to implement PPKM to date. Therefore, people are increasingly worried about leaving the house, especially for those who have to go to work, meet important people, return to their hometowns, and various other important activities. PCR is the answer and requirement for people who want to do important activities outside the home. However, the PCR test itself makes the public even more hesitant in carrying out the PCR test because the price is too high for the Indonesian people. The purpose of this study itself is to find out how the pricing policy of medical devices is seen from the perspective of the community and understand what are the factors that make medical devices and medicines expensive. Therefore, we conducted studies and research on government policies regarding medical devices that are still controversial as well as the pros and cons of pricing medical devices for Covid-19 detection. This type of research is normative legal research whose implementation is focused on collecting secondary data. This study concludes that the policies made by the government in determining the price of PCR are still not accessible to most Indonesians. The government should make new policies that are relevant for all Indonesian citizens in determining the price of PCR, medicines, and other medical devices. Factors that decrease the price of medical equipment itself are caused by the pressure and pressure experienced by the community. The community requested that the lowered price be affordable for all people without discriminating because all of them have the same rights in this regard, especially health. The quality of medical devices provided and provided is the best for the Indonesian people because the better the quality, the more people believe in the Covid-19 diagnostic test so that tracking, checking and treatment can reach all people quickly and responsively. The rights of Indonesian citizens in health must be fulfilled during this pandemic, as is the obligation of the state to protect its citizens without exception.Meningkatnya angka kasus Covid – 19 secara signifikan sejak bulan Desember 2020 sampai juni 2021 membuat Indonesia harus melaksanakan PPKM sampai saat ini.  Oleh karena itu masyarakat semakin khawatir untuk keluar rumah terutama bagi mereka yang harus pergi bekerja, bertemu orang penting, pulang kampung, dan berbagai kegiatan penting lainnya. PCR adalah jawaban dan syarat bagi masyarakat yang mau melakukan aktivitas diluar rumah yang penting. Namun tes PCR sendiri yang membuat masyarakat semakin bimbang dalam melakukan tes PCR disebabkan harga yang terlalu bagi masyarakat Indonesia. Tujuan penelitian ini sendiri adalah mengetahui bagaimana kebijakan penetapan harga alat kesehatan dilihat dari perspektif masyarakat dan memahami apa yang menjadi faktor-faktor mahalnya alat kesehatan maupun obat-obatan. Maka dari itu, kami melakukan studi dan penelitian tentang kebijakan pemerintah mengenai alat kesehatan yang masih kontroversi maupun pro dan kontra dalam masalah penetapan harga alat kesehatan deteksi Covid - 19. Jenis penelitian ini adalah penelitian hukum normatif yang pelaksanaanya difokuskan pada pengumpulan data sekunder. Penelitian ini menyimpulkan kebijakan yang dibuat pemerintah dalam penetapan harga PCR masih belum bisa dijangkau oleh sebagian besar masyarakat Indonesia. Pemerintah seharusnya membuat kebijakan baru yang relevan untuk semua warga Indonesia dalam penetapan harga PCR, obat-obatan, maupun alat kesehatan lainnya. Faktor-faktor menurunnya harga alat kesehatan sendiri itu disebabkan oleh desakan dan tekanan yang dialami masyarakat. Masyarakat meminta agar harga yang diturunkan bisa dijangkau oleh semua masyarakat tanpa membeda-bedakan karena semuanya mempunyai hak yang sama didalam hal ini khususnya kesehatan. Kualitas alat kesehatan yang diberikan dan disediakan adalah yang terbaik untuk masyarakat Indonesia karena semakin baik kualitasnya maka banyak masyarakat yang percaya akan tes diagnosa Covid – 19 sehingga pelacakan, pengecekan dan perawatan bisa merangkul semua masyarakat dengan cepat dan tanggap. Hak warga negara Indonesia dalam kesehatan harus dipenuhi dalam masa pandemi ini sebagaimana kewajiban negara dalam melindungi warga negaranya tanpa terkecuali.

Biosensors ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 469
Hsiao-Yu Yang ◽  
Wan-Chin Chen ◽  
Rodger-Chen Tsai

(1) Background: An electronic nose applies a sensor array to detect volatile biomarkers in exhaled breath to diagnose diseases. The overall diagnostic accuracy remains unknown. The objective of this review was to provide an estimate of the diagnostic accuracy of sensor-based breath tests for the diagnosis of diseases. (2) Methods: We searched the PubMed and Web of Science databases for studies published between 1 January 2010 and 14 October 2021. The search was limited to human studies published in the English language. Clinical trials were not included in this review. (3) Results: Of the 2418 records identified, 44 publications were eligible, and 5728 patients were included in the final analyses. The pooled sensitivity was 90.0% (95% CI, 86.3–92.8%, I2 = 47.7%), the specificity was 88.4% (95% CI, 87.1–89.5%, I2 = 81.4%), and the pooled area under the curve was 0.93 (95% CI 0.91–0.95). (4) Conclusion: The findings of our review suggest that a standardized report of diagnostic accuracy and a report of the accuracy in a test set are needed. Sensor array systems of electronic noses have the potential for noninvasiveness at the point-of-care in hospitals. Nevertheless, the procedure for reporting the accuracy of a diagnostic test must be standardized.

Neonatology ◽  
2021 ◽  
pp. 1-9
Aisling A. Garvey ◽  
Andreea M. Pavel ◽  
Deirdre M. Murray ◽  
Geraldine B. Boylan ◽  
Eugene M. Dempsey

<b><i>Introduction:</i></b> Hypoxic ischaemic encephalopathy (HIE) remains one of the top 10 contributors to the global burden of disease. Early objective biomarkers are required. Near-infrared spectroscopy (NIRS) may provide a valuable insight into cerebral perfusion and metabolism. We aimed to determine whether early NIRS monitoring (&#x3c;6 h of age) can predict outcome as defined by grade of encephalopathy, brain MRI findings, and/or neurodevelopmental outcome at 1–2 years in infants with HIE. <b><i>Methods:</i></b> We searched PubMed, Scopus, Web of Science, Embase, and The Cochrane Library databases (July 2019). Studies of infants born ≥36<sup>+0</sup> weeks gestation with HIE who had NIRS recording commenced before 6 h of life were included. We planned to provide a narrative of all the studies included, and if similar clinically and methodologically, the results would be pooled in a meta-analysis to determine test accuracy. <b><i>Results:</i></b> Seven studies were included with a combined total of 161 infants. Only 1 study included infants with mild HIE. A range of different oximeters and probes were utilized with varying outcome measures making comparison difficult. Although some studies showed a trend towards higher cSO<sub>2</sub> values before 6 h in infants with adverse neurodevelopmental outcomes, in the majority, this was not significant until beyond 24 h of life. <b><i>Conclusion:</i></b> Very little data currently exists to assess the use of early NIRS to predict outcome in infants with HIE. Further studies using a standardized approach are required before NIRS can be evaluated as a potential objective assessment tool for early identification of at-risk infants.

Pathogens ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1515
Matthew F. Flynn ◽  
Martin Kelly ◽  
James S. G. Dooley

Nasal pathogen detection sensitivities can be as low as 70% despite advances in molecular diagnostics. This may be linked to the choice of sampling method. A diagnostic test accuracy review for sensitivity was undertaken to compare sensitivity of swabbing to the nasopharynx and extracting nasal aspirates, using the PRISMA protocol, Cochrane rapid review methodology, and QUADAS-2 risk of bias tools, with meta-analysis of included studies. Sensitivities were calculated by a consensus standard of positivity by either method as the ‘gold standard.’ Insufficient sampling methodology, cross sectional study designs, and studies pooling samples across anatomical sites were excluded. Of 13 subsequently eligible studies, 8 had ‘high’ risk of bias, and 5 had ‘high’ applicability concerns. There were no statistical differences in overall sensitivities between collection methods for eight different viruses, and this did not differ with use of PCR, immunofluorescence, or culture. In one study alone, Influenza H1N1(2009) favored nasopharyngeal swabs, with aspirates having 93.3% of the sensitivity of swabs (p > 0.001). Similarly equivocal sensitivities were noted in reports detecting bacteria. The chain of sampling, from anatomical site to laboratory results, features different potential foci along which sensitivity may be lost. A fair body of evidence exists that use of a different sampling method will not yield more respiratory pathogens.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Jean-Bertin Bukasa Kabuya ◽  
Matthew M. Ippolito ◽  
Jay Sikalima ◽  
Clifford Tende ◽  
Davies Champo ◽  

Abstract Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by the World Health Organization for the prevention of malaria in pregnancy (MIP)-associated adverse outcomes in high burden areas. However, the efficacy of IPTp-SP has decreased in step with increasing parasite drug resistance. Suitable alternative strategies are needed. Methods This is a protocol for a phase IIIb open-label, two-armed randomized controlled superiority trial to assess the safety and efficacy of a hybrid approach to IPTp combining screening and treatment with dihydroartemisinin-piperaquine (DP) to the current IPTp-SP regimen at the first antenatal care clinic visit. Pregnant women without HIV infection and without signs or symptoms of malaria will be randomized to either standard IPTp-SP or hybrid IPTp-SP plus screening and treatment (IPTp-SP+). In the IPTp-SP+ arm, participants who screen positive by rapid diagnostic test for P. falciparum will be treated with DP at the first antenatal visit while those who screen negative will receive SP per current guidelines. All participants will be administered SP on days 35 and 63 and will be actively followed biweekly up to day 63 and then monthly until delivery. Infants will be followed until 1 year after delivery. The primary endpoint is incident PCR-confirmed MIP at day 42. Secondary endpoints include incident MIP at other time points, placental malaria, congenital malaria, hemoglobin trends, birth outcomes, and incidence of adverse events in infants up to the first birthday. Discussion A hybrid approach to IPTp that combines screening and treatment with an artemisinin-based combination therapy at the first visit with standard IPTp-SP is hypothesized to confer added benefit over IPTp-SP alone in a high malaria transmission area with prevalent SP resistant parasites. Trial registration Pan African Clinical Trials Registry 201905721140808. Registered retrospectively on 11 May 2019

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