Validity of Chemiluminescent Immunoassay Serology Test for Anti-Sars Cov-2 Antibodies IgM and IgG 1

2021 ◽  
Vol 28 (1) ◽  
pp. 26
Author(s):  
Museyaroh Museyaroh ◽  
Puspa Wardhani ◽  
Aryati Aryati
Keyword(s):  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Igg Antibodies ◽  
Diagnostic Specificity ◽  
Chain Reaction ◽  
New Type ◽  
Serology Test ◽  
Chemiluminescent Immunoassay ◽  
Polymerase Chain

In December 2019, an outbreak of acute pneumonia occurred in Wuhan, China. The disease was transmitted betweenhumans through droplets (coughing or sneezing) of infected patients, causing this outbreak to spread rapidly in variouscountries in the world, including Indonesia. On February 11, 2020, WHO announced the pneumonia was caused byCoronavirus Disease 2019 (COVID-19), which was caused by a new type of Coronavirus, the SARS-CoV-2. A rapid andaccurate diagnosis is critical for the control of the COVID-19 outbreak. The widely used test is a serology-based test thatdetects the presence of SARS-CoV-2 IgM/IgG antibodies in the patient's body. One of the methods used for this test isChemiluminescent Immunoassay (CLIA). This study aimed to determine the reliability of CLIA. The study was conductedfrom August to September 2020. The number of samples was 63 patients' serum. Polymerase chain reaction examination atHusada Utama Hospital, Surabaya, revealed that 21 patients were confirmed positive for COVID-19 with positive PCRresults, and 42 patients were healthy with negative COVID-19 results. The results showed that IgM had a diagnosticsensitivity of 85.7%, diagnostic specificity of 92.8%, a positive predictive value of 85.7%, a negative predictive value of 92.8%,and accuracy of 90.4%. In comparison, IgG had a diagnostic sensitivity of 90.4%, diagnostic specificity of 90.4%, a positivepredictive value of 82.6%, a negative predictive value of 90.5%, and accuracy of 90.4%. In conclusion, IgG has a highersensitivity than IgM, while IgM had higher specificity, positive predictive value, and negative predictive value than IgG.However, the positive, negative predictive value and efficiency values were the same for IgM and IgG.

scholarly journals A Comparison of Ligase Chain Reaction to Polymerase Chain Reaction in the Detection ofChlamydia trachomatisEndocervical Infections

1998 ◽  
Vol 6 (2) ◽  
pp. 57-60 ◽  
Author(s):  
J. D. Davis ◽  
P. K. Riley ◽  
C. W. Peters ◽  
K. H. Rand
Keyword(s):  
Polymerase Chain Reaction ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Gold Standard ◽  
Chain Reaction ◽  
True Negative ◽  
Predictive Values ◽  
Ligase Chain Reaction ◽  
Polymerase Chain

Objective:To compare the reliability of ligase chain reaction (LCR) to polymerase chain reaction (PCR) in detectingChlamydia trachomatisendocervical infections.Methods:We conducted a prospective study of 486 patients at risk for chlamydial infection of the endocervix. We obtained two endocervical specimens from each patient and used LCR and PCR to detectC. trachomatis. Discrepant results between the two techniques were resolved by repeat testing and by testing for the major outer membrane protein (MOMP) gene, if necessary. We determined the sensitivity, specificity, positive predictive value, and negative predictive value for each test, using concordant results or MOMP gene results as the “gold standard”.Results:Of the 486 patients, 42 (8.6%) had evidence ofC. trachomatisinfection after resolution of discrepant results. Of the 42 true positive specimens, 41 were positive by initial LCR and 38 were positive by initial PCR. Of the 444 true negative specimens, none had a positive initial LCR result, while 2 had a positive initial PCR test. Therefore, compared to the gold standard, LCR had a sensitivity of 97.6% and specificity of 100%, while PCR had a sensitivity of 90% and a specificity of 99.5%. The positive and negative predictive values of LCR were 100% and 99.8%, respectively. PCR had a positive predictive value of 95% and a negative predictive value of 99.1%. The difference in sensitivity of LCR versus PCR was not statistically significant (P= .125).Conclusion:LCR and PCR perform equally well in detectingC. trachomatisendocervical infections.

scholarly journals Peripheral Blood Leukocytes and Serum Nested Polymerase Chain Reaction Are Complementary Methods for Monitoring Active Cytomegalovirus Infection in Transplant Patients

2013 ◽  
Vol 24 (3) ◽  
pp. e69-e74 ◽  
Author(s):  
PD Andrade ◽  
MT Fioravanti ◽  
EBV Anjos ◽  
C De Oliveira ◽  
DM Albuquerque ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Cytomegalovirus Infection ◽  
Clinical Symptoms ◽  
Peripheral Blood Leukocytes ◽  
Active Infection ◽  
Chain Reaction ◽  
Blood Leukocytes ◽  
Polymerase Chain

BACKGROUND: Human cytomegalovirus is an important cause of morbidity and mortality in immunocompromised patients. Qualitative polymerase chain reaction (PCR) has proven to be a sensitive and effective technique in defining active cytomegalovirus infection, in addition to having low cost and being a useful test for situations in which there is no need for quantification. Real-time PCR has the advantage of quantification; however, the high cost of this methodology makes it impractical for routine use.OBJECTIVE: To apply a nested PCR assay to serum (sPCR) and to evaluate its efficiency to diagnose active cytomegalovirus infection compared with PCR of peripheral blood leukocytes (L-PCR).METHODS: Samples of 37 patients were prospectively evaluated. An internal control was created and applied to sPCR to exclude false-negative results.RESULTS: In total, 21 patients (57%) developed active cytomegalovirus infection. After analyzing the two methods for the diagnosis of active infection, higher sensitivity and negative predictive value of the L-PCR versus sPCR (100% versus 62%), and higher specificity and positive predictive value of sPCR versus L-PCR (81% versus 50% and 72%, respectively) were observed. Discordant results were observed in 11 patients who were L-PCR-positive but sPCR-negative for active cytomegalovirus infection, five of whom developed clinical symptoms of cytomegalovirus. Clinical symptoms were observed in 14 patients, 12 of whom were diagnosed with active infection by nested L-PCR (P=0.007) and seven by nested sPCR (P=0.02). Higher specificity and a positive predictive value for sPCR were observed.CONCLUSION: Nested L-PCR and sPCR were considered to be complementary methods for the diagnosis and management of symptomatic cytomegalovirus infection.

scholarly journals Prediction of Clostridium difficile infection in patients with polymerase chain reaction using a classification and regression tree

2020 ◽  
Author(s):  
Diana Martínez-Ruíz ◽  
Luis Gabriel Parra-Lara ◽  
Fernando Rosso
Keyword(s):  
Polymerase Chain Reaction ◽  
Clostridium Difficile ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Regression Tree ◽  
Antifungal Drugs ◽  
Classification And Regression Tree ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
Classification And Regression

Abstract BackgroundClostridium difficile infection (CDI) is commonly diagnosed with the polymerase chain reaction (PCR), but this test finds a high percentage of false positives, so their use and interpretation in CDI is a challenge in the clinical practice. That is why it is necessary to define an algorithm to optimize the use of PCR that considers clinical characteristics to classify patients with diarrhea as CDI or without CDI. ObjectiveTo identify a predictive algorithm with the clinical features that best classify patients with CDI vs. without CDI, to help physicians in making decisions to request PCR. Materials and methodsA case-control study was conducted at Fundación Valle del Lili. The population was inpatients between 2012 and 2016, with 18 or more years, and diarrhea, abdominal pain, or other nonspecific gastrointestinal symptoms who underwent PCR. Cases were defined as patients with positive PCR for C. difficile and as controls patients with negative PCR for C. difficile. Predictive algorithms to classify patients was constructed using a classification tree, classification and regression tree (CART). ResultsA total of 149 patients were included (48 cases with positive PCR and 99 controls with negative PCR). The CART has a high capacity to classify patients with a negative PCR correctly. It includes variables about the history of antibiotics use, the use of proton-pump inhibitor, the use of ranitidine, and the use of antifungal drugs. The CART showed sensitivity 64.6%, specificity 85.8%, positive predictive value 68.8%, negative predictive value 83.3%. and AUC 79.7%.DiscussionCART had good specificity and a high negative predictive value; it could be considered as an algorithm to identify conditions that indicate when it is not necessary to perform a PCR test in a patient symptom of CDI.

scholarly journals Detection of Chlamydia trachomatisEndocervical Infections by Ligase Chain Reaction versus ACCESSChlamydia Antigen Assay

1999 ◽  
Vol 37 (9) ◽  
pp. 3072-3073 ◽  
Author(s):  
K. B. Waites ◽  
K. R. Smith ◽  
M. A. Crum ◽  
R. D. Hockett ◽  
A. H. Wells ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Test Performance ◽  
Predictive Value ◽  
Grey Zone ◽  
Chain Reaction ◽  
Ligase Chain Reaction ◽  
Antigen Assay ◽  
Improve Access ◽  
Chlamydial Infections

Ligase chain reaction (LCR) was compared with ACCESS immunoassay for detection of chlamydial infections in females. Despite efforts to improve ACCESS performance by evaluation of specimens that were in the test performance “grey zone,” LCR remained more sensitive and was less expensive to perform. ACCESS had a sensitivity of 83.9%, a specificity of 99.7%, a positive predictive value of 96.3%, and a negative predictive value of 98.5%.

scholarly journals Evaluation of Nested Polymerase Chain Reaction targeting hsp65 of Mycobacterium tuberculosis for the Detection of Organism in the Sputum Samples

2016 ◽  
Vol 20 (1) ◽  
pp. 28-33
Author(s):  
Yogaraje GC Varadaiah ◽  
Raghu K Chinnappa ◽  
Rakshitha M Nagaraj ◽  
Thejashwini NA ◽  
Robinson K Samuel ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Mycobacterium Tuberculosis ◽  
Negative Predictive Value ◽  
Nested Pcr ◽  
Predictive Value ◽  
Healthy Controls ◽  
Chain Reaction ◽  
Nested Polymerase Chain Reaction ◽  
Gene Target ◽  
Polymerase Chain

ABSTRACT Introduction The poor sensitivity of conventional smear microscopy and the delay in obtaining Mycobacterium culture results prevent the early diagnosis of Myobacterium tuberculosis (MTB). By using nucleic acid amplification techniques like polymerase chain reaction (PCR), one may be able to diagnose the disease on the day of arrival of specimen in the laboratory. The present study aimed to evaluate the applicability of the nested-PCR (nPCR) technique as a rapid and direct molecular method for the diagnosis of M. tuberculosis in sputum specimens of patients whose sputum smear was acid-fast bacilli (AFB) negative using heat shock protein (hsp65) as the gene target. Materials and methods Early morning sputum samples were collected in sterile containers respectively from about 40 suspected patients of pulmonary tuberculosis, attending the outpatient units of JSS Medical College and PKTB Hospital, Mysore and from 20 age and sex-matched healthy controls. Sputum samples were decontaminated by modified Petroff's method and DNA was isolated using QIAGEN DNA extraction kit. The nPCR was carried out for the detection of MTB using the target gene hsp65. Results Nested-PCR showed specific amplification (165bp) of M. tuberculosis in 18 out of 20 sputum AFB positive samples and 9 out of 20 AFB negative samples. None of the healthy controls showed any amplification with nPCR. The nPCR when compared to that of Ziehl-Neelsen staining had a sensitivity of 90%, specificity of 77.5%, positive predictive value (PPV) of 66.6%, and negative predictive value (NPV) of 93.9%. The percentage of false positive was 33.3% and percentage of false negative was 6.1%. Conclusion The detection of M. tuberculosis with nPCR in smear negative patients provides the bacteriological data 4 to 8 weeks earlier. A molecular approach, based on the amplification of hsp65 gene by nPCR, showed that there is high probability of the disease being absent when the test is negative because of the high negative predictive value (NPV). How to cite this article Varadaiah YGC, Prashant A, Chinnappa RK, Nagaraj RM, Thejashwini, Samuel RK, Devegowda D, Vishwanath P. Evaluation of Nested Polymerase Chain Reaction targeting hsp65 of Mycobacterium tuberculosis for the Detection of Organism in the Sputum Samples. Indian J Med Biochem 2016;1(1):28-33.

Introduction of routine polymerase chain reaction testing for Neisseria gonorrhoeae in a community laboratory

Sexual Health ◽  
2013 ◽  
Vol 10 (4) ◽  
pp. 387 ◽  
Author(s):  
Arlo Upton ◽  
Janet Wilson ◽  
Liselle Bissessor
Keyword(s):  
Polymerase Chain Reaction ◽  
Neisseria Gonorrhoeae ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Positive Culture ◽  
Chain Reaction ◽  
Polymerase Chain Reaction Testing ◽  
Additional Testing ◽  
Polymerase Chain ◽  
Culture Negative

We introduced polymerase chain reaction (PCR) testing for Neisseria gonorrhoeae (NG) on the Cobas 4800 CT/NG assay for all samples received with a Chlamdyia trachomatis request in March 2012. From 1 March 2012 to 30 June 2012, all PCR-positive/culture-negative specimens had additional testing at another assay. A total of 40053 tests were performed. The estimated specificity and positive predictive value were 99.9% and 97.1%, respectively; thus routine additional testing is not required.

scholarly journals Real-world evaluation of a computed tomography-first triage strategy for suspected Coronavirus disease 2019 in outpatients with fever in Japan: an observational cohort study

2020 ◽  
Author(s):  
Shigeta Miyake ◽  
Takuma Higurashi ◽  
Takashi Jono ◽  
Taisuke Akimoto ◽  
Fumihiro Ogawa ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Polymerase Chain Reaction ◽  
Cohort Study ◽  
Positive Predictive Value ◽  
Real World ◽  
Predictive Value ◽  
Chain Reaction ◽  
Triage Protocol ◽  
Polymerase Chain ◽  
Sensitivity Specificity

Abstract Background: The Coronavirus disease 2019 pandemic continues to spread worldwide. Because of the absence of reliable rapid diagnostic systems, patients with symptoms of Coronavirus disease 2019 are treated as suspected of the disease. Use of computed tomography findings in Coronavirus disease 2019 are expected to be a reasonable method for triaging patients, and computed tomography-first triage strategies have been proposed. However, clinical evaluation of a computed tomography-first triage protocol is lacking.The aim of this study is to investigate the real-world efficacy and limitations of a computed tomography-first triage strategy in patients with suspected Coronavirus disease 2019.Methods: This was a single-center cohort study evaluating outpatients with fever who received medical examination at Yokohama City University Hospital, prospectively registered between 9 February and 5 May 2020. We treated according to the computed tomography-first triage protocol. The primary outcome was efficacy of the computed tomography-first triage protocol for patients with fever in an outpatient clinic. Efficacy of the computed tomography-first triage protocol for outpatients with fever was evaluated using sensitivity, specificity, positive predictive value, and negative predictive value. We conducted additional analyses of the isolation time of feverish outpatients and final diagnoses.Results: In total, 108 consecutive outpatients with fever were examined at our hospital. Using the computed tomography-first triage protocol, 48 (44.9%) patients were classified as suspected Coronavirus disease 2019. Nine patients (18.8%) in this group were positive for severe acute respiratory syndrome coronavirus 2 using polymerase chain reaction; no patients in the group considered less likely to have Coronavirus disease 2019 tested positive for the virus. The sensitivity, specificity, positive predictive value, and negative predictive value of our computed tomography-first triage protocol for Coronavirus disease 2019 were 100%, 60.2%, 18.8%, and 100%, respectively. The protocol significantly shortened the duration of isolation for the not-suspected versus the suspected group (70.5 vs. 1037.0 minutes, P < .001). Conclusions: Our computed tomography-first triage protocol was acceptable for screening patients with suspected Coronavirus disease 2019. This protocol will be helpful for appropriate triage, especially in areas where polymerase chain reaction is inadequate.

scholarly journals Added value of diffusion-weighted MRI in assessment of pleural lesions

2021 ◽  
Vol 52 (1) ◽  
Author(s):  
Youssriah Yahia Sabri ◽  
Ikram Hamed Mahmoud ◽  
Lamis Tarek El-Gendy ◽  
Mohamed Raafat Abd El-Mageed ◽  
Sally Fouad Tadros
Keyword(s):  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Diagnostic Value ◽  
Added Value ◽  
Adc Value ◽  
Pleural Diseases ◽  
Conventional Mri ◽  
Malignant Lesions

Abstract Background There are many causes of pleural disease including variable benign and malignant etiologies. DWI is a non-enhanced functional MRI technique that allows qualitative and quantitative characterization of tissues based on their water molecules diffusivity. The aim of this study was to evaluate the diagnostic value of DWI-MRI in detection and characterization of pleural diseases and its capability in differentiating benign from malignant pleural lesions. Results Conventional MRI was able to discriminate benign from malignant lesions by using morphological features (contour and thickness) with sensitivity 89.29%, specificity 76%, positive predictive value 89%, negative predictive value 76.92%, and accuracy 85.37%. ADC value as a quantitative parameter of DWI found that ADC values of malignant pleural diseases were significantly lower than that of benign lesions (P < 0.001). Hence, we discovered that using ADC mean value of 1.68 × 10-3 mm2/s as a cutoff value can differentiate malignant from benign pleural diseases with sensitivity 89.3%, specificity 100%, positive predictive value 100%, negative predictive value 81.2%, and accuracy 92.68% (P < 0.001). Conclusion Although DWI-MRI is unable to differentiate between malignant and benign pleural effusion, its combined morphological and functional information provide valid non-invasive method to accurately characterize pleural soft tissue diseases differentiating benign from malignant lesions with higher specificity and accuracy than conventional MRI.

Accuracy of Medical Examiner’s Assessment for Near–Real-Time Surveillance of Fatal Drug Overdoses, King County, Washington, March 2017–February 2018

2021 ◽  
pp. 003335492110084
Author(s):  
Kirsten Vannice ◽  
Julia Hood ◽  
Nicole Yarid ◽  
Meagan Kay ◽  
Richard Harruff ◽  
...  
Keyword(s):  
Public Health ◽  
Positive Predictive Value ◽  
Real Time ◽  
Negative Predictive Value ◽  
Drug Overdose ◽  
Predictive Value ◽  
Death Certificate ◽  
King County ◽  
Public Health Response ◽  
Drug Overdoses

Objectives Up-to-date information on the occurrence of drug overdose is critical to guide public health response. The objective of our study was to evaluate a near–real-time fatal drug overdose surveillance system to improve timeliness of drug overdose monitoring. Methods We analyzed data on deaths in the King County (Washington) Medical Examiner’s Office (KCMEO) jurisdiction that occurred during March 1, 2017–February 28, 2018, and that had routine toxicology test results. Medical examiners (MEs) classified probable drug overdoses on the basis of information obtained through the death investigation and autopsy. We calculated sensitivity, positive predictive value, specificity, and negative predictive value of MEs’ classification by using the final death certificate as the gold standard. Results KCMEO investigated 2480 deaths; 1389 underwent routine toxicology testing, and 361 were toxicologically confirmed drug overdoses from opioid, stimulant, or euphoric drugs. Sensitivity of the probable overdose classification was 83%, positive predictive value was 89%, specificity was 96%, and negative predictive value was 94%. Probable overdoses were classified a median of 1 day after the event, whereas the final death certificate confirming an overdose was received by KCMEO an average of 63 days after the event. Conclusions King County MEs’ probable overdose classification provides a near–real-time indicator of fatal drug overdoses, which can guide rapid local public health responses to the drug overdose epidemic.

scholarly journals Role of annexin A2 and osteopontin for early diagnosis of hepatocellular carcinoma in hepatitis C virus patients

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Abd El-Fattah F. Hanno ◽  
Fatma M. Abd El-Aziz ◽  
Akram A. Deghady ◽  
Ehab H. El-Kholy ◽  
Aborawy I. Aborawy
Keyword(s):  
Hepatocellular Carcinoma ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Early Diagnosis ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Chronic Hepatitis C ◽  
Predictive Value ◽  
Annexin A2 ◽  
Alpha Fetoprotein

Abstract Background Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Early stages of hepatocellular carcinoma (0&A) can be treated with curative procedures. The aim of this work was to evaluate the role of annexin A2 and osteopontin for early diagnosis of hepatocellular carcinoma in hepatitis C virus patients. Methods The study was carried out on 80 patients classified into two groups. Group A had 40 chronic hepatitis C patients without hepatocellular carcinoma, while group B had 40 chronic hepatitis C patients with early hepatocellular carcinoma (stages; 0&A). All patients were subjected to thorough history taking, clinical examination, liver function tests, renal function tests, serum alpha-fetoprotein, serum osteopontin, and serum annexin A2. Results Serum alpha-fetoprotein was found to be statistically significantly higher in patients with the hepatocellular carcinoma group than the chronic hepatitis C group. The ROC curve for alpha-fetoprotein for detection of HCC was significant, its diagnostic performance was 0.818* (p < 0.001*), and the cutoff point for predicting the probability for HCC was 6.0 (ng/ml) with sensitivity of 77.50%, specificity of 82.50%, positive predictive value of 81.60%, negative predictive value of 78.6%, and accuracy of 80%. Serum osteopontin was found to be statistically significantly higher in patients from the hepatocellular carcinoma group than the chronic hepatitis C group. The ROC curve for osteopontin was significant, its diagnostic performance was 0.739* (p < 0.001*), the cutoff point was 13.2 (ng/ml) with sensitivity of 65.0%, specificity of 90.0%, positive predictive value of 86.70%, negative predictive value of 72.0%, and accuracy of 77.0%. Serum annexin A2 was found to be statistically significantly higher in patients from the hepatocellular carcinoma group than the chronic hepatitis C group. The ROC curve for annexin A2 was significant, its diagnostic performance was 0.927* (p < 0.001*), the cutoff point was 10.1(ng/ml) with sensitivity of 85.0%, specificity of 85.0%, positive predictive value of 85.0%, negative predictive value of 85.0%, and accuracy of 85.0%. Conclusions Osteopontin had better specificity but lower sensitivity than serum alpha-fetoprotein for early diagnosis of hepatocellular carcinoma. Annexin A2 had better diagnostic sensitivity and specificity than alpha-fetoprotein for early diagnosis of hepatocellular carcinoma.

Sign in / Sign up

Export Citation Format

Share Document