Evaluating the Performance of Four SARS-CoV-2 Commercial Chemiluminescence Immunoassays

2021 ◽  
Vol 30 (1) ◽  
pp. 71-77
Author(s):  
Sahar M. Khairat ◽  
Nancy ELGuindy ◽  
Amany E. Sheta ◽  
Usama A. Bahaa Eldin ◽  
Yasmin Adel El-Mahdy ◽  
...  

Background: COVID-19 is a pandemic of serious global threat that forced test developers to flood the market with various diagnostic assays that have been independently validated. Objectives: This study aims at assessing the performance of four SARS-CoV-2 chemiluminescence immunoassays. Methodology: The present study included sera from 96 Polymerase Chain Reaction (PCR)–confirmed COVID-19 cases collected at 2 time periods (5-9 days and 9-14 days post symptom onset) during patient follow-up, and 30 control sera from COVID-19 PCR–negative individuals. All sera were tested for SARS-CoV-2 antibodies using four high-throughput commercially available chemiluminescence immunoassays: YHLO Biotech Co, Ltd China (IgM and IgG); Abbott, Abbott USA (IgG); Roche, Roche US (total: IgM, IgG, and IgA), and Ortho, Ortho Clinical Diagnostics, USA (total and individual IgG). Results: For the detection of total antibodies (IgM, IgG, and IgA), the highest sensitivities were for Ortho followed by Roche assays (91.6% and 84.3% in 5-9 days period, respectively) raised to 96.8% and 92.7% in 9-14 days respectively with significant difference P-value <0.00001. Ortho, Roche, and YHLO iFlash (IgM) assays had specificities of 100%, 100%, and 90.3% respectively. Roche (Total) and Ortho (Total) assays showed perfect categorical agreement (94.4% in 5-9 days, and 96.4% in 9-14 days). As for the detection of individual IgG antibodies, the Abbott assay had the highest sensitivity (91.6% in 5-9 days, and 93.7% in 9-14 days), followed by Ortho and YHLO iFlash assays (84.3%, and 83.3% in 5-9 days respectively) that increased to 89.5% and 88.5% in 9-14 days respectively. Ortho assay was the best in specificity (100%), followed by Abbott (98.8%) and YHLO iFlash (96.3%). YHLO iflash (IgG) and Ortho (IgG) showed perfect agreement (96.8%) in the 2 time frames. Conclusion: Ortho assay showed the best performance in detecting total antibodies with perfect match to Roche assay, while Abott assay was the best performing in detecting individual IgG with perfect match to Ortho assay rendering them to be efficient diagnostic tools

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Amal A Abu El Maati ◽  
Samar R Ragheb ◽  
Esraa E Moustafa

Abstract Aim of the Work to compare between HHUS and 3D ABUS, according to their benefits and limitations as a complementary scan for mammography in detection of breast lesions. Patients and Methods The study was conducted on 30 female patients with breast masses diagnosed by clinical examination or by sonomammography in Radiology Department at Al Sheikh Zayed Aal Nahian hospital and Ain Shams University Hospitals during the period from October 2018 and August 2019. Findings were confirmed by histopathological biopsy or at least 6 months follow up. Results Statistically significant difference between ABUS and HHUS time of examination in favor of ABUS with P-value &gt;0.0001 and 95%CI-5.7:-4.4, as ABUS time of examination was (mean+/- SD: 4.1 +/-0.9) and HHUS was (mean +/- SD: 9.2 +/-2.0). In this study; 8 out of 30 were malignant lesions and 22 were benign findings. HHUS showed higher sensitivity than ABUS (100% versus 88%); specificity (86%, 91%), positive predictive value (73%, 78%) and negative predictive value (100%, 95%) respectively. HHUS and ABUS shows nearly perfect agreement regarding lesion classification(benign &malignant).with Cohen’s kappa (κ) 0.85, and also regarding BIRADS classification With Weighted kappa 0.824. Conclusion There is a near perfect agreement between ABUS and HHUS diagnostic performance (κ) 0.85,and statistically significant difference in time of examination in favor of ABUS as it is operator independent and provide large scanned area in every single sweep and also aided with computer software, but HHUS still have higher sensitivity than ABUS and that may be attributed to ABUS limitations to evaluate axillary lymph nodes and lack of Doppler, so ABUS may serve as an effective, adjunct, screening tool to mammography and hand held Sonography.


Author(s):  
Shruti Baruah ◽  
Pratibha Vyas ◽  
Arpit Srivastava

<p class="abstract"><strong>Background:</strong> Diagnostic nasal endoscopy and CT imaging are both widely used essential diagnostic tools for chronic rhinosinusitis (CRS). This study analyses their individual roles in the management of CRS as well as the degree of correlation between the two.</p><p class="abstract"><strong>Methods:</strong> A prospective observational comparative study was conducted in the Department of Otorhinolaryngology, Mahatma Gandhi Hospital, Jaipur from January, 2017 to June, 2018 on a sample size of 201 patients diagnosed with chronic rhinosinusitis, as per AAOHNS guidelines. DNE and CT PNS were done for all patients enrolled in the study, the findings of each were correlated and their individual sensitivity and specificity for each variable was calculated.  </p><p class="abstract"><strong>Results:</strong> On Comparing CT findings with diagnostic nasal endoscopic findings, Polyps were seen in 91 patients’ CT scans as opposed to 124 on DNE. B/L Polyps on CT imaging vs bilateral ethmoidal polyps visualized during DNE revealed a highly significant “P” value; whereas for antrochoanal polyps or unilateral polyps there was no significant difference. Maxillary sinus involvement is the most commonly observed finding in CT scan of PNS in CRS while deviated nasal septum is the most common finding on a diagnostic nasal endoscopy, seen in 60.7%. For anatomical variants like concha bullosa and paradoxical middle turbinate, no significant difference was seen.</p><p class="abstract"><strong>Conclusions:</strong> CT scans and DNE are both key pre-operative diagnostic tools for patients of CRS and both are complementary to each other in detecting type and extent of pathology.</p>


Author(s):  
Jau-Tsuen Kao ◽  
I-Li Wong ◽  
Jeen-Yih Lee ◽  
Ruey-Chean Chen

Myocardial infarction is a common cause of morbidity and mortality in patients with chest pain. The presence of human cardiac troponin I (cTnI) in serum is considered to be a highly specific biochemical marker of acute myocardial infarction. In this study we compare the performances of the Abbott AxSYM, Behring Opus Plus, DPC Immulite and Ortho-Clinical Diagnostics Vitros ECi for the measurement of cTnI. The first two methods use a fluorogenic enzyme-linked immunoassay, whereas the last two use chemiluminescent immunometric assays. All procedures are completely automated. Total percentage coefficients of variation using pooled sera ranged from 5·9 to 6·5% for the AxSYM, 14·4 to 25·6% for the Opus, 6·9 to 9·8% for the Immulite and 4·5 to 5·2% for the Vitros ECi method. The closest correlation between methods, obtained from 120 fresh serum samples, was observed between the Vitros ECi and the Immulite methods, with r=0·99, and the regression line was Immulite cTnI=1·505 (95% confidence interval 1·474-1·536) x Vitros cTnI-0·154 (-0·702 to 0·394). Receiver operating characteristic curves were nearly identical for all assays, and the areas under the curves were 0·972, 0·927, 0·967 and 0·969 for the AxSYM, Opus, Immulite and Vitros ECi methods, respectively. There was a significant difference between the AxSYM and Opus methods ( P=0·036).


2020 ◽  
Author(s):  
Shiwani Mahajan ◽  
Carrie A Redlich ◽  
Adam V Wisnewski ◽  
Louis E Fazen ◽  
Lokinendi V Rao ◽  
...  

Background: Several serological assays have been developed to detect anti-SARS-CoV-2 IgG antibodies, but evidence about their comparative performance is limited. We sought to assess the sensitivity of four anti-SARS-CoV-2 IgG enzyme-linked immunosorbent assays (ELISA) in individuals with evidence of prior SARS-CoV-2 infection. Methods: We obtained sera from 36 individuals with PCR-confirmed SARS-CoV-2 infection between March and May 2020. We evaluated samples collected at around 21 days (±14 days) after their initial PCR test using 3 commercially available ELISA assays, two anti-spike (Ortho-Clinical Diagnostics Vitros, and Euroimmun) and one anti-nucleocapsid (Abbott Architect), and a Yale-developed anti-spike ELISA test. We determined the sensitivity of the tests and compared their results. The Euroimmun and Yale ELISA had an equivocal and indeterminate category, which were considered as both negative and positive. Results: Among the 36 individuals with SARS-CoV-2 infection, mean age was 43 (±13) years and 19 (53%) were female. The sensitivities of the tests were not significantly different (Abbott Architect, Ortho Vitros, Euroimmmun, and Yale assays: 86% (95% confidence interval [CI], 71-95), 94% (95% CI, 81-99), 86% (95% CI, 71-95), and 94% (95% CI, 81-99), respectively; p-value=0.464). The sensitivities of the Euroimmun and Yale ELISA tests increased when the equivocal/indeterminate results were considered positive (97% [95% CI, 85-100] and 100% [95% CI, 90-100], respectively), but were not significantly different from other tests (p=0.082). The cross-correlation coefficient ranged from 0.85-0.98 between three anti-spike protein assays (Ortho Vitros, Euroimmun, Yale) and was 0.58-0.71 between the three anti-spike protein assays and the anti-nucleocapsid assay (Abbott). Conclusion: The sensitivities of four anti-SARS-CoV-2 protein assays did not significantly differ, although the sample size was small. Sensitivity also depended on the interpretation of equivocal and indeterminate results. The strongest correlations were present for the three anti-spike proteins assays. These findings suggest that individual test characteristics and the correlation between different tests should be considered when comparing or aggregating data across different populations studies for serologic surveillance of past SARS-CoV-2 infection.


2019 ◽  
Vol 4 (1) ◽  
pp. 1
Author(s):  
Dini Kesuma

Synthesis of the 4-chlorobenzoylthiourea compound was carried out by acylating thiourea with 4-chlorobenzoyl chloride. The 4-chlorobenzoylthiourea compound  will increase the lipophilic and the electronic properties other than the lead compounds of benzoylthiourea in order to, by expectation, raise the central nervous system depressant as well. The lipophilic would affect the ability of the compounds in penetrating biological membranes, which is highly dependent on the solubility of the drug within lipid/water. Log P is the most common method used in determining the parameter value. This experiment was to mix two dissolvents (octanol and water) which are immissible. The both levels of the compounds were carefully observed by a spectrophotometer UV-Vis. From the test, the result of log P value of the 4-chlorobenzoylthiourea compound was 2.32, while the theoretical log P value of the compounds, by using the π Hansch-Fujita method is 1.62 and the f Rekker-Mannhold method is 2.225. Consequently, the result of the test shows that there is a significant difference between the progress experiment and both theoretical log P methods. Moreover, in the test of the central nervous system depressant through the potentiation test to thiopental using mice indicates that the 4-chlorobenzoylthiourea compound have potentiation effects to thiopental compared to the lead compounds of benzoylthiourea.


Author(s):  
Eliyas Sulaiman Mohandas ◽  
Nik Mastura Nik Ismail Azlan ◽  
Salwa Othman ◽  
Muhammad Aizat Azhari

This study aims to investigate whether the use of six selected short stories throughout the duration of a 14-week course could enhance students’ reading comprehension achievement at the end of the semester. Out of the six short stories read, three were chosen as in-class assignments known as ‘Personal Reading Logs’ (hereafter, PRLs). One group of semester two Diploma students taking a reading skills course was selected through a convenience sampling method. A pre-test was conducted by having the students answer a past semester reading quiz of which the results would then be compared to their post-test (final reading exam) results. A paired samples t-test revealed no significant difference in the reading scores of the pre-test and the post-test, t (17) = -.265, p > .05. Since the p-value was bigger than 0.05, this indicated that the mean reading score of the post-test (M = 50.556) was not significantly higher than the mean reading score of the pre-test (M = 49.722). Therefore, the null hypothesis which stated that there was no difference in the mean score of the pre-test and post-test was retained. Overall, the result refuted the findings of other studies promoting the effectiveness of using short stories to enhance L2 reading comprehension achievement.


Author(s):  
Hilman Syarif

Introduction: Student Centered Learning (SCL) is an effective method to develop student's soft skills and hard skills which are very important to support their successful carrier later. This research was conducted to identify the differences of developed soft skills between students who learn with PBL method and lecturing method. Methods: Descriptive comparative method was used in this study. The samples consisted of 15 students who learned with PBL method and 15 students who learned with lecturing method. The sample for this research was selected by random sampling method. Results: The result showed that the average of student's soft skills score in PBL method was 122.63, while student's soft skills score in lecturing method was 116.27. Discussion & Conclusion: There was significant difference of student's soft skills in PBL method and lecturing method (p value = 0.038; α = 0.05). This study recommends nursing program management, faculty of medicine at the University of Syiah Kuala keeps PBL method running and develops other methods which facilitate hard skills and soft skills are development. Keywords: nursing students, soft skill, PBL


2018 ◽  
Vol 1 (2) ◽  
pp. 114
Author(s):  
Wahdaniah Wahdaniah ◽  
Sri Tumpuk

Abstract: Routine blood examination is the earliest blood test or screening test to determine the diagnosis of an abnormality. Blood easily froze if it is outside the body and can be prevented by the addition of anticoagulants, one of which Ethylene Diamine Tetra Acetate (EDTA). Currently available vacuum tubes containing EDTA anticoagulants in the form of K2EDTA and K3EDTA. K3EDTA is usually a salt that has better stability than other EDTA salts because it shows a pH approaching a blood pH of about 6.4. The purpose of this research is to know the difference of erythrocyte index results include MCH, MCV and MCHC using K3EDTA anticoagulant with K2EDTA. This research is a cross sectional design. This study used venous blood samples mixed with K2EDTA anticoagulant and venous blood mixed with K3EDTA anticoagulants, each of 30 samples. Data were collected and analyzed using paired different test. Based on data analysis that has been done on MCH examination, p value <0,05 then there is a significant difference between samples with K3EDTA anticoagulant with K2EDTA to erythrocyte index value. Then on the examination of MCV and MCHC obtained p value <0.05 then there is no significant difference between samples with K3EDTA anticoagulant with K2EDTA to erythrocyte index value.Abstrak: Pemeriksaan darah rutin merupakan pemeriksaan darah yang paling awal atau screening test untuk mengetahui diagnosis suatu kelainan. Darah mudah membeku jika berada diluar tubuh dan bisa dicegah dengan penambahan antikoagulan, salah satunya Ethylene Diamine Tetra Acetate (EDTA). Dewasa ini telah tersedia tabung vakum yang sudah berisi antikoagulan EDTA dalam bentuk  K2EDTA dan  K3EDTA. K3EDTA  biasanya berupa garam yang mempunyai stabilitas yang lebih baik dari garam EDTA yang lain karena menunjukkan pH yang mendekati pH darah yaitu sekitar 6,4. Tujuan dari penelitian ini adalah untuk mengetahui perbedaan hasil indeks eritrosit meliputi MCH, MCV dan MCHC menggunakan antikoagulan K3EDTA dengan K2EDTA. Penelitian ini merupakan penelitian dengan desain cross sectional. Penelitian ini menggunakan sampel darah vena yang dicampur dengan antikoagulan K2EDTA dan darah vena yang dicampur dengan antikoagulan K3EDTA, masing-masing sebanyak 30 sampel. Data dikumpulkan dan dianalisis menggunakan uji beda berpasangan. Berdasarkan analisis data yang telah dilakukan pada pemeriksaan MCH didapatkan nilai p < 0,05 maka ada perbedaan yang signifikan antara sampel dengan antikoagulan K3EDTA dengan K2EDTA terhadap nilai indeks eritrosit. Kemudian pada pemeriksaan MCV dan MCHC didapatkan nilai p < 0,05 maka tidak ada perbedaan yang signifikan antara sampel dengan antikoagulan K3EDTA dengan K2EDTA terhadap nilai indeks eritrosit.


2019 ◽  
Vol 43 (1) ◽  
pp. 50
Author(s):  
Aquirina Caesari Putri ◽  
Rozalina Loebis

Background: Pediatric cataracts are major causes of children’s blindness. Surgery has proven to be beneficial in terms of visual function prognosis. Contrast sensitivity evaluation after surgery is as important as visual acuity considering that natural world consists of various objects in low-to-medium contrasts. The purpose of this study is to analyze the difference of contrast sensitivity outcomes based on ages at surgery. Method: Retrospective data of children with pediatric developmental cataract from July 2013 to November 2015 were collected. All children who underwent cataract surgery at 60-months-old or less were randomized into two groups, ≤24 months and >24-to-60 months. Contrast sensitivity was then examined with preferential-looking method using Hiding Heidi low-contrast test face chart. The main outcome measures were contrast sensitivity of both groups. Age-at-evaluation, cataract onset, duration of follow-up, duration of deprivation and visual acuity were also noted. Result: Of 14 children (23 eyes), 11 eyes (47,8%) were in ≤24 months group, 12eyes (52,2%) were in >24-to-60 months group. All eyes underwent cataract extraction and similar type of intraocular lens implantation. Mean age-at-surgery was 28,2 months±16,8 (SD). Mean contrast sensitivity for each group was 47,50 %±42,29 and 18,33%±27,38, respectively, with p-value 0,031. Further analysis of Spearman’s correlation test demonstrated significant negative correlation (rs = -0,559; p = 0,006) between the two groups. Conclusion: There was statistically significant difference in contrast sensitivity between those who underwent surgery at ≤24 months and >24-to-60 months. Children who underwent surgery at older ages tend to have better contrast sensitivity afterwards.


2017 ◽  
Vol 3 (1) ◽  
Author(s):  
Tri Nurhudi Sasono

Abstract : Indicator of the health welfare through Sustanable Development Goals (SDGs) is to reduce the incidence of HIV-AIDS, decrease the rate of the epidemic and maintain the quality of life of people living with HIV-AIDS (PLWHA). Trend cases of HIV-AIDS is the most recent spread among people, especially housewives. In Malang until 2015 found 278 Housewife of 409 cases of AIDS. The prevalence of HIV-AIDS in Malang Regency is ranked second after Surabaya city in East Java. For the importance of public participation and citizen care AIDS Cahaya Care Turen take responsibility for the condition. Determination Rule Goverment number 2 2015 year on the Participation of the community response to HIV-AIDS in Malang as a legal rule. Concerned Citizens activities AIDS (WPA). WPA Cahaya Care Turen is increases HIV risk and quality of life PLWHA. The purpose of this study was to determine the role of Citizens AIDS Cahaya Care Quality of Care Turen against people living with HIV in Puskesmas Turen Malang. The study design using a quasi-experimental, with purposive sampling using a sampling technique. Total number of research subjects 23. Based on test results obtained with the Wilcoxon p value <0.005, which means that there is a significant difference before and after PLWHA joining participated in the WPA Cahaya Care Turen. The conclusion of this study is WPA activities involving people living with HIV and at risk groups can optimize compliance with antiretroviral drugs that have an impact on improving the quality of life of PLHIV. Suggestions in this research is done WPA Program activities are structured and ongoing cross-sector in order to improve the quality of life and empower PLWHA.Keywords : WPA Cahaya Care Turen, Quality of life, PLWHA Abstrak : Salah satu indikator kesejahteraan kesehatan melalui Sustanable Development Goals (SDGs) adalah menekan angka kejadian HIV-AIDS, menurunkan laju epidemik dan mempertahankan kualitas hidup Orang dengan HIV-AIDS (ODHA). Trend kasus HIV-AIDS terkini terbanyak adalah menjangkit dikalangan masyarakat khususnya pada ibu rumah tangga. Kabupaten Malang sampai dengan tahun 2015 ditemukan 278 Ibu Rumah Tangga dari 409 kasus AIDS. Prevalensi HIV-AIDS di Kabupaten Malang ini merupakan peringkat kedua di Jawa Timur setelah Kota Surabaya. Untuk itu pentingnya peran serta masyarakat dan warga peduli AIDS Cahaya Care Turen ikut bertanggung jawab terhadap kondisi tersebut. Penetapan Peraturan Bupati Malang no.2 th.2015 tentang Peran serta masyarakat penanggulangan HIV-AIDS di Kabupaten Malang diharapkan dapat mengurangi risiko penularan HIV dan meningkatkan kualitas hidup ODHA. Tujuan dari penelitian ini adalah untuk mengetahui Peran Warga Peduli AIDS Cahaya Care Turen terhadap Kualitas ODHA Di Wilayah Kerja Puskesmas Turen Kabupaten Malang. Desain penelitian menggunakan quasi eksperimen, dengan teknik sampling menggunakan purposive sampling. Jumlah subyek penelitian sejumlah 23. Berdasarkan hasil uji dengan Wilcoxon didapatkan nilai p value < 0.005 yang berarti bahwa terdapat perbedaan bermakna sebelum dan sesudah ODHA bergabung mengikuti kegiatan WPA Cahaya Care Turen. Kesimpulan dalam penelitian ini adalah kegiatan WPA dengan melibatkan ODHA dan kelompok beresiko dapat mengoptimalkan kepatuhan obat ART sehingga berdampak terhadap peningkatan kualitas hidup ODHA. Saran dalam penelitian ini adalah dilakukannya Program kegiatan WPA yang terstruktur dan berkesinambungan lintas sektor guna meningkatkan kualitas hidup dan memberdayakan ODHA.     Kata kunci : WPA Cahaya Care Turen, kualitas hidup, ODHA


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