scholarly journals VALIDATION OF ANTIBODY RAPID TEST FOR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 INFECTION IN BETHESDA HOSPITAL YOGYAKARTA

2021 ◽  
Vol 18 (2) ◽  
pp. 78-83
Author(s):  
Fenty Fenty ◽  
Ivan Lim ◽  
Frida E.W. ◽  
Kristiani D. ◽  
Rizaldi Pinzon

Since March 2020, Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection has been around in Indonesia with a case fatality rate was 4.7% on August, 1th 2020. So far, the Real-Time Polymerase Chain Reaction (RT-PCR) method is the gold standard for the SARS-CoV-2 infection diagnosis. This method, however, has some limitations where it has a long turnaround time, complicated operations, and high prices. Hence, the rapid test kits are now readily available to identify the SARS-CoV-2 patients. The purpose of this study is to measure the diagnostic performance, including sensitivity, specificity, positive and negative predictive value, likelihood ratio or LR of antibody rapid test if compared with RT-PCR for the SARS-CoV-2 suspected patients in Bethesda Hospital Yogyakarta. This research was analytical observational research with a cross-sectional design approach, in which data were collected retrospectively. The instruments used in this study included e-medical record (ERM), Laboratory Information System (LIS) data from patients with suspected SARS-CoV-2 infection in Bethesda Hospital Yogyakarta. We collected demographic data of patients, RT-PCR results, antibody rapid test results using Standard Q COVID-19 IgM/IgG Combo. The data were obtained from 50 patients. The results showed that the Rapid test kit has a 100% sensitivity value, 74.4% specificity value, 38.9% positive and 100% negative predictive value, 3906 positive likelihood ratio compared with the RT-PCR results.

Author(s):  
Jesha Mundodan ◽  
Samina Hasnain ◽  
Hayat Khogali ◽  
Soha Shawqi Al Bayat ◽  
Dina Ali ◽  
...  

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar.  Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.


Author(s):  
Muhamad Ramdani Ibnu Taufik ◽  
Dian Ariningrum ◽  
Yusuf Ari Mashuri

The diagnosis of Urinary Tract Infection (UTI) in infants and children is often missed. There have been no studies ondiagnostic tests using automated urine analyzer in pediatric patients. This study aimed to determine the cut-off values ofbacteriuria and leukocyturia using the automated urine analyzer Sysmex UX-2000 to diagnose UTI with the gold standard ofautomated urine culture using VITEK 2 in pediatric patients at Dr. Moewardi Hospital, Surakarta. An observational analyticalstudy with the cross-sectional design was during August-October 2019 at the Clinical Pathology Laboratory and ClinicalMicrobiology Laboratory of Moewardi Hospital, Surakarta. Eighty-four patients sample were collected. This study'sdependent variable was the diagnosis of urinary tract infections in pediatric patients established with positive culture results(bacterial count of ≥ 105 CFU/mL urine). This study's independent variables were the number of urine bacteria (BACT) andthe number of urine leukocytes (WBC) from urinalysis using the Sysmex UX-2000 automated urine analyzer. A diagnostictest was used for data analysis. The best cut-off value for leukocyturia was 37 cells/μL with a 61.1% sensitivity, 63.6%specificity, a positive predictive value of 31.4%; a negative predictive value of 85.7; positive likelihood ratio of 1.64; negativelikelihood ratio of 0.595, and accuracy of 63%. The best cut-off for the number of bacteria was 143 cells/μL with a sensitivityof 66.7%; specificity of 71.2%, the positive predictive value of 38.7%, the negative predictive value of 88.7%; positivelikelihood ratio of 2.14; negative likelihood ratio of 0.432 and an accuracy of 70.2%. A cut-off of 37 cells/μL for leukocyturiaand 143 cells/μL for bacteriuria using an automated urine analyzer can be used for UTI screening in pediatric patients.


2018 ◽  
Vol 17 (3) ◽  
pp. 455-461
Author(s):  
Md Nurullah ◽  
Md Shah Alam ◽  
Mahmud Hossen ◽  
Marufa Shahnawaz

Background: Management of airway is central to the Practice of anaesthesia. One of the anaesthesiologist fundamental roles is to maintain a patent airway at a all times.Maintaining a patent airway is essential for adequate oxygenation and ventilation and failure to do so, even for a brief period of time, can be life threatening. Recently, thyromental height test (TMHT) has been proposed as one of the highly sensitive and specific bedside tests to predict difficult airway.Objective: To assess the predictivity of thyromental height test in comparison to modified Mallampati test.Methods: This cross sectional study was carried out in Anesthesiology department of ISMCH during the period of January, 2015 to December, 2016. A total number of 139 consecutive patients scheduled for elective surgical procedure under general anaesthesia requiring intubation having American Society of Anesthesiologists grading I-II. Statistical analyses of the results were obtained by SPSS-20. Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Thyromental height test and Modified mallampati scoring in diagnosis of difficult airway were calculated.Results: Most (74.4) of the patients belonged to age ≤50 years. Male to female ratio was 1.01:1. Majority 91(65.5%) patients had thyromental height of ≥50 mm. In the diagnosis of difficult airway, Thyromental height test was 92.7% sensitivity, 93.5% specificity, 93.5% accuracy and 85.4% positive predictive values, 97.8% negative predictive value, 13.1% positive likelihood ratio, 0.05 negative likelihood ratio. On the other hand Modified mallampati scoring was 48.8% sensitivity, 92.7% specificity, 79.1% accuracy, 75.0% positive predictive values, 80.2% negative predictive value, 6.7% positive likelihood ratio, 0.55 negative likelihood ratio for prediction of difficult airway.Conclusions: It can be concluded that the thyromental height is useful diagnostic modality for predicting difficult airway.Bangladesh Journal of Medical Science Vol.17(3) 2018 p.455-461


CJEM ◽  
2009 ◽  
Vol 11 (02) ◽  
pp. 156-160 ◽  
Author(s):  
Daniel McDermott ◽  
James V. Quinn ◽  
Charles E. Murphy

ABSTRACT Objective: We sought to determine the incidence of acute myocardial infarction (AMI) in emergency department (ED) patients with syncope, the characteristics of these AMIs and how helpful the initial electrocardiogram (ECG) was in identifying these cases. Methods: In a prospective cohort of consecutive patients with syncope, the initial ECG was found to be abnormal using a prespecified definition (any nonsinus rhythm or any new or age-indeterminate abnormalities). Patients were then followed up to identify an AMI diagnosed within 30 days of presentation. Results: There were 1474 consecutive patient visits for syncope or near-syncope over a 45-month period spanning from Jul. 1, 2000, to Feb. 28, 2002, and Jul. 15, 2002, to Aug. 31, 2004, of which 46 (3.1%) were diagnosed with AMI. The majority of the AMI patients (42) had no ST segment elevation. The initial ECG was abnormal in 37 out of 46 cases. The diagnostic performance of the initial ECG was sensitivity 80% (95% confidence interval [CI] 67%–89%), specificity 64% (95% CI 61%–67%), negative predictive value 99% (95% CI 98%–100%), positive predictive value 7% (95% CI 6%–8%), positive likelihood ratio 2.2 (95% CI 1.6–2.5) and negative likelihood ratio 0.3 (95% CI 0.2–0.5). Conclusion: The incidence of AMI in patients presenting with syncope is low. A normal ECG has a high negative predictive value, although its sensitivity is limited.


2017 ◽  
Vol 45 (5) ◽  
Author(s):  
Noppadol Chaiyasit ◽  
Roberto Romero ◽  
Piya Chaemsaithong ◽  
Nikolina Docheva ◽  
Gaurav Bhatti ◽  
...  

AbstractObjective:Clinical chorioamnionitis is the most common infection/inflammatory process diagnosed in labor and delivery units worldwide. The condition is a syndrome that can be caused by (1) intra-amniotic infection, (2) intra-amniotic inflammation without demonstrable microorganisms (i.e. sterile intra-amniotic inflammation), and (3) maternal systemic inflammation that is not associated with intra-amniotic inflammation. The presence of intra-amniotic inflammation is a risk factor for adverse maternal and neonatal outcomes in a broad range of obstetrical syndromes that includes clinical chorioamnionitis at term. Although the diagnosis of intra-amniotic infection has relied on culture results, such information is not immediately available for patient management. Therefore, the diagnosis of intra-amniotic inflammation could be helpful as a proxy for intra-amniotic infection, while results of microbiologic studies are pending. A rapid test is now available for the diagnosis of intra-amniotic inflammation, based on the determination of neutrophil collagenase or matrix metalloproteinase-8 (MMP-8). The objectives of this study were (1) to evaluate the diagnostic indices of a rapid MMP-8 test for the identification of intra-amniotic inflammation/infection in patients with the diagnosis of clinical chorioamnionitis at term, and (2) to compare the diagnostic performance of a rapid MMP-8 test to that of a conventional enzyme-linked immunosorbent assay (ELISA) interleukin (IL)-6 test for patients with clinical chorioamnionitis at term.Materials and methods:A retrospective cohort study was conducted. A transabdominal amniocentesis was performed in patients with clinical chorioamnionitis at term (n=44). Amniotic fluid was analyzed using cultivation techniques (for aerobic and anaerobic bacteria as well as genital Mycoplasmas) and broad-range polymerase chain reaction (PCR) coupled with electrospray ionization mass spectrometry (PCR/ESI-MS). Amniotic fluid IL-6 concentrations were determined by ELISA, and rapid MMP-8 results were determined by Yoon’s MMP-8 CheckResults:(1) A positive rapid MMP-8 test had a sensitivity of 82.4% (28/34), specificity of 90% (9/10), positive predictive value of 96.6% (28/29), negative predictive value of 60% (9/15), positive likelihood ratio 8.2 (95% CI 1.3–53.2), and negative likelihood ratio 0.2 (95% CI 0.1–0.4) for the identification of intra-amniotic inflammation (prevalence 77.3%); (2) a positive rapid MMP-8 test had a sensitivity of 91.7% (22/24), specificity of 65% (13/20), positive predictive value of 75.9% (22/29), negative predictive value of 86.7% (13/15), positive likelihood ratio of 2.6 (95% CI 1.4–4.8), and negative likelihood ratio of 0.1 (95% CI 0.03–0.5) for the identification of intra-amniotic infection; (3) the rapid MMP-8 test had a significantly higher specificity than the ELISA IL-6 test in the identification of intra-amniotic inflammation as determined by an amniotic fluid WBC count ≥50 cells/mmConclusion:The rapid diagnosis of intra-amniotic inflammation is possible by analysis of amniotic fluid using a point-of-care test for MMP-8. Patients with a positive test are at risk of delivering a neonate affected with systemic inflammation, a risk factor for adverse neonatal outcome.


2021 ◽  
Vol 55 (2) ◽  
Author(s):  
RYNER JOSE CARRILLO ◽  
Abigail D. Sarmiento ◽  
Mark Anthony C. Ang ◽  
Michelle H. Diwa ◽  
Cecille C. Dungog ◽  
...  

Objective. To determine the diagnostic accuracy of self-collected snorted and spit saliva in detecting COVID-19 using RT-PCR (ssRT-PCR) and lateral flow antigen test (ssLFA) versus nasopharyngeal swab RT-PCR (npRT-PCR). Methods. One hundred ninety-seven symptomatic subjects for COVID-19 testing in a tertiary hospital underwent snort-spit saliva self-collection for RT-PCR and antigen testing and nasopharyngeal swab for RT-PCR as reference. Positivity rates, agreement, sensitivity, specificity, and likelihood ratios were estimated. Results. Estimated prevalence of COVID-19 using npRT-PCR was 9% (exact 95% CI of 5.5% - 14.1%). A higher positivity rate of 13% in the ssRT-PCR assay suggested possible higher viral RNA in the snort-spit samples. There was 92.9% agreement between ssRT-PCR and npRT-PCR (exact 95% CI of 88.4% to 96.1%; Cohen’s Kappa of 0.6435). If npRT-PCR will be assumed as reference standard, the estimated Sensitivity was 83.3% (exact 95% CI of 60.8% to 94.2%), Specificity 93.9% (exact 95% CI of 89.3% to 96.5%), Positive predictive value of 57.7% (exact 95% CI of 38.9% to 74.5%), Negative predictive value of 98.2% (exact 95% CI of 95% to 99.4%), positive likelihood ratio of 3.65 (95% CI of 7.37 to 24.9), negative likelihood ratio of 0.178 (95% CI of 0.063 to 0.499). There was 84.84% agreement (95% exact CI of 79.1% to 89.5%; Cohen’s Kappa of 0.2356) between ssLFAvs npRT-PCR, sensitivity of 38.9% (exact 95% CI of 20.3% to 61.4%), specificity of 89.4% (exact 95% CI of 84.1% to 93.1%), PPV of 26.9% (95% CI of 13.7% to 46.1%), NPV of 93.6% (exact 95% CI of 88.8% to 96.4%), LR+ of 3.67 (95% CI of 1.79 - 7.51), LR – of 0.68 (95% CI of 0.47 - 0.99). Conclusion. Our data showed that snort-spit saliva RT-PCR testing had acceptable diagnostic performance characteristics and can potentially be used as an alternative to the standard nasopharyngeal/oropharyngeal swab RT-PCR test for COVID-19 in certain situations. However, our data also showed that snort-spit saliva antigen testing using lateral flow assay did not offer acceptable performance.


2021 ◽  
Author(s):  
IRERI THIRION-ROMERO ◽  
SELENE GUERRERO-ZUNIGA ◽  
ALEXANDRA ARIAS-MENDOZA ◽  
DORA PATRICIA CORNEJO-JUAREZ ◽  
PATRICIA MEZA-MENESES ◽  
...  

BACKGROUND Point-of-care rapid tests to identify SARS-CoV-2 can be of great help because, in principle, they allow decisions to be made at the site of care for treatment, or for the separation of cohorts avoiding cross-infection, especially in emergency situations. METHODS A cross sectional study in adults requesting care in Emergency Rooms (ER), or the outpatient clinics of referral hospitals for COVID-19, to define the diagnostic characteristics of a rapid antigen test for SARS-CoV-2 (the Abbott PanbioTM) having as a gold standard the RT-PCR for SARS-CoV-2. Health personnel in a routine situation within an active pandemic in several cities of Mexico performed the tests. RESULTS A total of 1,069 participants with a mean age of 47 years (SD 16 years), 47% with a self-reported comorbidity, and an overall prevalence of a positive RT-PCR test of 45%, were recruited from eight hospitals in Mexico. Overall sensitivity of the Panbio test was 54.4% (95%CI 51-57) with a positive likelihood ratio of 35.7, a negative likelihood ratio of 0.46 and a Receiver-Operating Characteristics curve area of 0.77. Positivity for the rapid test depended strongly on an estimate of the viral load (Cycle threshold of RT-PCR, Ct), and the days of symptoms. With a Ct 25, sensitivity of the rapid test was 0.82 (95%CI, 0.76-0.87). For patients during the first week of symptoms sensitivity was 69.6% (95%CI 66-73). On the other hand, specificity of the rapid test was above 97.8% in all groups. CONCLUSIONS The PanbioTM rapid antigen test for SARS-CoV-2 has a good specificity, but due to low and heterogeneous sensitivity in real life, a negative test in a person with suggestive symptoms at a time of community transmission of SARS-CoV-2 requires confirmation with RT-PCR, and after the first week of symptoms, sensitivity decreases considerably.


2020 ◽  
Vol 7 (6) ◽  
pp. 1225
Author(s):  
Gokul Krishnan R. ◽  
Mangalabharathi S. ◽  
Mohammed Sajjid ◽  
Ramya S.

Background: Endtidalcarbonmonoxide (ETCOc) and Carboxyhemoglobin (COHB) levels correlate well to bilirubin production and an availability of non-invasive point of care (POC) device in predicting significant hyperbilirubinemia is of great advantage when compared to measurement of serum bilirubin. Objective of the study is to measure a value of ETCOc and COHB in the early neonatal period for the prediction of significant hyperbilirubinemia.Methods: This was the descriptive Cross Sectional Study. ETCOc and COHB were measured 12th hourly for 72 hours followed by TSB in whom the TCB was >14mg/dl. Neonates were classified as jaundiced whose TSB values were in phototherapy range as per AAP Recommendations. Receiver Operative Curves (ROC) were created by appropriate statistical software for ETCOc and COHb to predict significant hyperbilirubinemia. The Sensitivity, Specificity, Positive predictive value, Negative predictive value and likelihood ratios of each was determined and the correlation between ETCOc and COHb levels, ETCOc and TCB, COHB and TCB at different hours of age was evaluated.Results: Among the total 320 infants, 156 of them developed significant hyperbilirubinemia. The ETCOc and COHB level at 60 hours of age was the most predictive of significant hyperbilirubinemia by ROC analysis. ETCOc cut-off of 1.65 ppm at 60 hours of age has a sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio of 84.6%, 80.5%, 80.5% and 84.6%, 4.33 and 0.19. COHB cut-off of 1.32 ppm at 60 hours of age has a sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio of 84.6%, 81%, 80% and 84.2%, 4.34 and 0.19.ETCOc had a maximum correlation with COHB at 48 hours of age.Conclusions: An increased level of Endtidalcarbonmonoxide and Carboxyhemoglobin in the early neonatal period is useful as a screening test for prediction of significant hyperbilirubinemia.


2021 ◽  
Vol 8 (03) ◽  
pp. 146-150
Author(s):  
Rishav Prasad ◽  
Guddakesh Kumar ◽  
Prashant Sinha ◽  
Dipu Singh

BACKGROUND In clinical practice, breast lump is a very common presentation of numerous breast diseases which ranges from benign cysts to malignant lesions. The difference between benign and malignant is very important for patient care and proper management. The diagnosis of breast lump includes clinical examination supplemented by imaging. Various literature has concluded that ultrasound evaluation with fine needle aspiration cytology (FNAC) correlation has comparable sensitivity and specificity to histopathology. Our aim was to study the ultrasonographic characteristics of breast lesions in patients and compare the sensitivity of ultrasonography in diagnosing benign and malignant breast lesions with FNAC. METHODS This is a diagnostic validation study, conducted at Department of Radiodiagnosis and Department of Pathology, Narayan Medical College and Hospital. All females more than 30 years coming for routine breast screening, found to have Breast Imaging Reporting and Data System (BI-RADS) 2 and above were subjected to ultrasonography and FNAC under ultrasonography (USG) guidance, and compared with histopathology. Data was collected, entered and analysed using Microsoft Excel, Epi Info, and SPSS software. Sensitivity and specificity with correlation, positive predictive value (PPV), negative predictive value (NPV) was calculated to compare the two diagnostic modalities. RESULTS USG had 83.3 % sensitivity, 97.56 % specificity, 95.24 % positive predictive value, 90.91 % negative predictive value, 33.32 % positive likelihood ratio and 17.13 % negative likelihood ratio. FNAC had 96.67 % sensitivity, 97.56 % specificity, 96.67 % positive predictive value, 97.56 % negative predictive value, 38.66 % positive likelihood ratio and 3.42 % negative likelihood ratio. CONCLUSIONS Breast ultrasound and FNAC both are important diagnostic tools for breast lesion. Sensitivity, specificity and other features are better for FNAC than ultrasound for breast lump. KEYWORDS Breast Lump, FNAC, USG, Adenocarcinoma, Squamous Cell Carcinoma


2016 ◽  
Vol 48 (5) ◽  
pp. 299
Author(s):  
Thermiany AS ◽  
W Retayasa ◽  
M Kardana ◽  
IN Lila

Background Neonatal sepsis is a major cause of morbidity andmortality. A positive blood culture is the gold standard fordiagnosis of neonatal sepsis. The signs and symptoms suggestingneonatal sepsis are non-specific. There is no rapid and reliablelaboratory test findings for confirmation of etiologic diagnosis.Clinical signs, symptoms, and laboratory examinations are notperceived as sensitive or specific for diagnosis of sepsis.Objective The purpose of this study was to evaluate the accuracyof the septic markers for diagnosis of neonatal sepsis.Methods Blood culture was used as gold standard to compareseptic markers to diagnose neonatal sepsis. Sensitivity, specificity,positive predictive value (PPV), negative predictive value (NPV),positive and negative likelihood ratio (LR), and accuracy werecalculated.Results We identified 130 cases suspected of neonatal sepsis duringSeptember 2005 until March 2006. Four patients were excludedbecause of major congenital anomalies. The mean age was 2.2 daysand 51.6% were boys. We found fifty six (44.4%) neonates havepositive blood culture. All of septic markers had sensitivity morethan 80%. Immature to Total Neutrophil ratio (Iff) ratio had thehighest sensitivity (96.4%) and C-Reactive Protein (CRP) had thelowest sensitivity (80.4o/o). Combination among leukocyte count,thrombocyte, and Iff ratio had the highest sensitivity (sensitivitywas 85. 7%, specificity was 97.1 o/o, positive predictive value was95.9%, negative predictive value was 89.5%, accuracy was 94.4%,and positive likelihood ratio was 30.0).Conclusion Septic markers can be used in the diagnosticevaluation of neonates with suspected sepsis.


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