A comparative study between placental alpha microglobulin-1 rapid immunoassay and standard diagnostic methods for detection of rupture of membranes

Background: To determine the efficacy of an immunoassay to measure levels of placental alpha-microglobulin-1 in cervico-vaginal secretions.Methods: 100 ANC cases admitted in Dr D. Y. Patil Hospital with symptoms of rupture of membranes during study period. Inclusion criteria-Pregnant women who presented with symptoms of ROM either in labour or not in labour, gestational age from 28 weeks onwards and who have given consent.Results: In 9 cases, the immunoassay test was negative, in 91 cases, it was positive and in one case, the liquor had a lot of meconium, the woman had to undergo an emergency cesarean section. This patient was deemed to have a false negative result by the test. Pooling was positive in 87 cases, nitrazine test in 86 cases and ferning in 88 cases. Hence, in comparison to immunoassay test which had 100% specificity and 98.91% sensitivity due to incomplete evaluation, nitrazine test had 95.58% sensitivity and 100% specificity, Pooling has 97.79% sensitivity and 100% specificity, whereas ferning has 98.34% sensitivity and 100% specificity.Conclusions: The PAMG1 is a non-invasive, rapid, one step test with very high sensitivity, specificity and accuracy as compared to the conventional methods together and also individually. Preforming this test instead of conventional methods can aid the early detection of rupture of membranes and largely affect the outcome of maternal and fetal health as timely decision can be taken once diagnosis is confirmed.

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Metal Oxide Nanorods-Based Sensor Array for Selective Detection of Biomarker Gases

Sensors ◽

10.3390/s21051922 ◽

2021 ◽

Vol 21 (5) ◽

pp. 1922

Author(s):

Gwang Su Kim ◽

Yumin Park ◽

Joonchul Shin ◽

Young Geun Song ◽

Chong-Yun Kang

Keyword(s):

Real Time ◽

Sensor Array ◽

High Sensitivity ◽

Gas Analysis ◽

Diagnostic Methods ◽

Real Time Monitoring ◽

Non Invasive ◽

Sensitivity And Selectivity ◽

Breath Gas Analysis ◽

Angle Method

The breath gas analysis through gas phase chemical analysis draws attention in terms of non-invasive and real time monitoring. The array-type sensors are one of the diagnostic methods with high sensitivity and selectivity towards the target gases. Herein, we presented a 2 × 4 sensor array with a micro-heater and ceramic chip. The device is designed in a small size for portability, including the internal eight-channel sensor array. In2O3 NRs and WO3 NRs manufactured through the E-beam evaporator’s glancing angle method were used as sensing materials. Pt, Pd, and Au metal catalysts were decorated for each channel to enhance functionality. The sensor array was measured for the exhaled gas biomarkers CH3COCH3, NO2, and H2S to confirm the respiratory diagnostic performance. Through this operation, the theoretical detection limit was calculated as 1.48 ppb for CH3COCH3, 1.9 ppt for NO2, and 2.47 ppb for H2S. This excellent detection performance indicates that our sensor array detected the CH3COCH3, NO2, and H2S as biomarkers, applying to the breath gas analysis. Our results showed the high potential of the gas sensor array as a non-invasive diagnostic tool that enables real-time monitoring.

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Targeted next generation sequencing to expand HER2 status detection: Implication for newer HER2-directed agents.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.1047 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 1047-1047

Author(s):

Ning Liao ◽

RongFeng Song ◽

FangQin Xue ◽

Shuirong Zhang ◽

Samuel J Klempner ◽

...

Keyword(s):

Clinical Laboratory ◽

False Negative ◽

High Sensitivity ◽

Expression Level ◽

Her2 Status ◽

Genomic Alteration ◽

Her2 Expression ◽

Specificity And Sensitivity ◽

Sensitivity Specificity ◽

Erbb2 Amplification

1047 Background: Establishment of ERBB2 ( HER2) amplification status in breast carcinoma (BC) and gastric carcinoma (GC) is essential for treatment selection, but no anti- HER2 therapies have been approved for tumors with low level of HER2 expression. The clinical trial ( NCT02564900 ) was initiated to evaluate the safety and efficacy of trastuzumab deruxtecan (DS-8201a) in BC patients with lower HER2 expression by current methods. This study aims to validate NGS-based detection for HER2 low expression. Methods: 275 BC and 425 GC were collected and subjected to NGS for genomic alteration detection. The testing was carried out by a College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, Shanghai, China. Protein expression was analyzed by using IHC. FISH was carried out on 108 samples, including 63 BC and 45 GC. To set up NGS cutoff, FISH was performed on additional 34 samples. Sensitivity, specificity and accuracy were evaluated based on FISH as a gold-standard reference. Results: In BC, the expression level of HER2 protein detected by IHC was overall IHC 0 in 28.7%, 1+ in 18.9%, 2+ in 27.3% and 3+ in 25.1%, respectively, while in GC, the expression level was 60.7%, 18.6%, 14.8% and 5.9%, respectively. Log2ratio was used to assess ERBB2 amplification status detected by NGS. According to the FISH results of 34 other samples with high sensitivity (98%) and specificity (100%), the threshold was determined as 0.5. 8 and 10 samples of IHC 1+/2+ met the cutoff in BC and GC, respectively. In 63 BC, there were 17 positive and 46 negative by FISH. According to the threshold, the sensitivity and specificity of NGS detection was 94.1% and 97.8%, respectively. The proportion of samples with IHC 2+ that couldn't determine NGS ERBB2 status was 49.2%. However, except for false positive and false negative, the NGS results were concordant with FISH. In 45 GC, there were 5 positive and 40 negative by FISH. The specificity and sensitivity was 97.5% and 40%, respectively. In 4 samples with IHC 2+, 2 of them were discordant with the results of NGS and FISH. All IHC 1+ didn't meet the cutoff of NGS and was FISH negative in 108 samples. The accuracy of NGS in ERBB2 detection was 96.8% and 91.1% for BC and GC, respectively. Conclusions: Our data indicated that the NGS-based detection of ERBB2 amplification had high sensitivity, specificity and accuracy. In samples with IHC 1+/2+, the results of NGS detection were high concordant with FISH detection.

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The role and diagnostic value of the most common methods for diagnosing Helicobacter pylori infection

HERALD of North-Western State Medical University named after I I Mechnikov ◽

10.17816/mechnikov201911459-66 ◽

2020 ◽

Vol 11 (4) ◽

pp. 59-66

Author(s):

Alexander V. Tryapitsyn ◽

Vladimir A. Mal’kov

Keyword(s):

Helicobacter Pylori ◽

Gastric Mucosa ◽

False Negative ◽

High Sensitivity ◽

Diagnostic Value ◽

Diagnostic Methods ◽

Helicobacter Pylori Infection ◽

Unexpected Result ◽

Optimal Method ◽

Histochemical Test

The purpose of the study was to identify and evaluate the practical value of the most common diagnostic methods for Helicobacter pylori infection in patients with chronic inflammation of the gastric mucosa. Materials and methods. The study involved 104 people. All the patients examined underwent esophagogastroduodenoscopy with a rapid urease histochemical test for Helicobacter pylori and a standard five-point biopsy of the gastric mucosa for morphological evaluation and bacterioscopy. If the result of the quick urease histochemical test coincided with the data of the biopsy study on Helicobacter pylori, no further examination was carried out. In case of discrepancy the patients additionally underwent the 13C-urease breath test. Results. It was found that the sensitivity of the rapid urease histochemical test in the area of the proposed model, according to our study, was 89.74% and the specificity was 46.15% when validating it using the additional methods. Similar calculations for the diagnostic method of staining by Giemsa showed sensitivity of 100% and specificity of 97.4%. The total number of the infected in the survey was 78 out of 104 people, which amounted to 75%. When analysing the severity of activity, inflammation and atrophic changes in the gastric mucosa, it was found that in the patients with two positive tests, the severity of the processes was significantly higher than in those with one positive test or all the tests were negative (p 0.05). When comparing the same processes in cases where only a quick urease histochemical test was positive and no signs of Helicobacteriosis were detected in any test, no significant differences were detected. Discussion. The rapid urease histochemical test showed good sensitivity of 89.74%, but unsatisfactory specificity of 46.15%, which severely limits its use. An unexpected result for this methodology was a large number of false positive tests, while the European recommendations indicate a more frequent occurrence of false negative results, which can be explained by differences in the production technology of the test systems. High sensitivity and specificity of the Helicobacter pylori test using Giemsa staining strongly depends on observing the methodology and experience of a specialist and cannot be recommended as a standard in the routine medical use. The study confirmed the recommendations for using at least two diagnostic tests to diagnose the infection, while the most common rapid urease histochemical test always needs confirmation. As a result of the analysis, it can be said that esophagastroduodenoscopy with a rapid urease histochemical test for Helicobacter pylori and standard diagnostic biopsy is the optimal method for diagnosing the pathology of the upper sections of the gastrointestinal tract. Moreover, 13C-UDT seems to be almost ideal as a screening technique and for evaluating treatment in cases where endoscopic monitoring is not necessary.

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Seroprevalence of HbsAg and anti-HCV in Ghurki Teaching Hospital, Lahore

Annals of King Edward Medical University ◽

10.21649/akemu.v11i3.1008 ◽

2016 ◽

Vol 11 (3) ◽

Author(s):

Rizwan Waseem ◽

Muhammad Ali Kashif ◽

Muhammad Khan ◽

Abdul Waheed Qureshi

Keyword(s):

General Population ◽

Hepatitis B ◽

Teaching Hospital ◽

Population Based ◽

Step Test ◽

P Value ◽

Younger Age ◽

One Step ◽

Hbs Ag ◽

Very High

Objective: To find out the prevalence of hepatitis B and C in general population. Design: This is an analytical type of and non-interventional study. Setting: Data was collected from a two-day free screening camp for hepatitis B and C at Ghurki Trust Teaching Hospital, Lahore. Material and method: Normal people of any age and either sex were included in the study. Screening was performed for Hbs Ag and Anti HCV by Acu-check one step test (chromatographic immunoassay) in serum. Results: A total 1680 subjects were screened for both Hbs Ag and Anti HCV. Prevalence of Hbs Ag was 2.97% and Anti HCV was 11.96%. The mean age was 24.96 14.67 years. Females were 55.2% and males were 44.8%. seroprevalence in females and males of Hb Ag was 1.2% and 1.78% and that of Anti HCV 8.6% and 3.33% respectively. These gender differences are statistically significant (p value <0.05). Hbs Ag was more prevalent in younger population (up to 10 years). The majority of Anti HCV positive was in 31 to 40 years of age. Conclusion: Seroprevalence of Hbs Ag and Anti HCV is high in general population. Prevalence of HCV is very high in younger age group while Hbs Ag is very high in children up to 10 years of age. Larger population based studies are needed to confirm the results.

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COVID-19 pneumonia: Significance of diagnostic approaches other than PCR testing

Sestrinska vizija ◽

10.5937/sestrviz2007025j ◽

2020 ◽

Vol 4 (7) ◽

pp. 25-28

Author(s):

Jovan Javorac ◽

Dejan Živanović ◽

Ana Milenković ◽

Zvonko Dimoski

Keyword(s):

False Negative ◽

Fatal Outcome ◽

High Sensitivity ◽

Lung Parenchyma ◽

Diagnostic Methods ◽

Pcr Analysis ◽

Nasopharyngeal Swab ◽

Test Results ◽

Radiological Findings ◽

Diagnostic Approaches

The infection by SARS-CoV-2 virus leads to the development of COVID-19 disease, which can manifest asymptomatically, or cause pneumonia caracterised by mild to severe symptoms, with potential fatal outcome. The gold diagnostic standard for COVID-19 disease is the PCR analysis of biological materials sampled by nasopharyngeal swab. However, despite the high sensitivity of this diagnostic method, our clinical experience has shown that in some cases, false-negative PCR test results can be obtained. This paper reports a case of a patient with developed pneumonia that could be related to COVID-19 disease based on the clinical picture, laboratory and radiological findings, but two nasopharyngeal swabs were negative for SARS-CoV-2 after PCR analysis. The patient was treated with the therapy recommended for COVID-19, achieving both clinical and radiological improvement, which indicates that the infection by SARS-CoV-2 virus was probably the UN-derlying factor of of the inflammatory process in the lung parenchyma. Therefore, the aim of this paper is to highlight the importance of other diagnostic methods in diagnosing COVID-19, not only PCR testing.

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Cell-free DNA screening for aneuploidies in 7113 pregnancies: single Italian centre study

Genetics Research ◽

10.1017/s001667232000004x ◽

2020 ◽

Vol 102 ◽

Cited By ~ 1

Author(s):

Alvaro Mesoraca ◽

Katia Margiotti ◽

Claudio Dello Russo ◽

Anthony Cesta ◽

Antonella Cima ◽

...

Keyword(s):

Sex Chromosome ◽

Clinical Performance ◽

False Negative ◽

Prenatal Testing ◽

High Sensitivity ◽

Trisomy 13 ◽

Sequencing Platform ◽

Non Invasive ◽

Negative Results ◽

False Negative Results

Abstract Introduction Non-invasive prenatal testing (NIPT) using cell-free foetal DNA has been widely accepted in recent years for detecting common foetal chromosome aneuploidies, such as trisomies 13, 18 and 21, and sex chromosome aneuploidies. In this study, the practical clinical performance of our foetal DNA testing was evaluated for analysing all chromosome aberrations among 7113 pregnancies in Italy. Methods This study was a retrospective analysis of collected NIPT data from the Ion S5 next-generation sequencing platform obtained from Altamedica Medical Centre in Rome, Italy. Results In this study, NIPT showed 100% sensitivity and 99.9% specificity for trisomies 13, 18 and 21. Out of the 7113 samples analysed, 74 cases (1%) were positive by NIPT testing; foetal karyotyping and follow-up results validated 2 trisomy 13 cases, 5 trisomy 18 cases, 58 trisomy 21 cases and 10 sex chromosome aneuploidy cases. There were no false-negative results. Conclusion In our hands, NIPT had high sensitivity and specificity for common chromosomal aneuploidies such as trisomies 13, 18 and 21.

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Will Fluoroscopic Follow-up after Stent-Assisted Coiling of Cerebral Aneurysms Provide Information on Recanalization?

Interventional Neuroradiology ◽

10.15274/inr-2014-10062 ◽

2014 ◽

Vol 20 (6) ◽

pp. 693-703 ◽

Cited By ~ 1

Author(s):

Hyun Ho Oh ◽

Cheolkyu Jung ◽

Tae Hong Lee ◽

Bae Ju Kwon ◽

Young Kim ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Imaging Modality ◽

False Negative ◽

Cerebral Aneurysms ◽

High Sensitivity ◽

Outpatient Basis ◽

Good Imaging ◽

Sensitivity Specificity ◽

Interreader Agreement

Fluoroscopic images for comparison (FICs) can be easily obtained for follow-up on an outpatient basis. This study retrospectively assessed the diagnostic performance of a set of FICs for evaluation of recanalization after stent-assisted coiling, with digital subtraction angiography (DSA) as the reference standard. A total of 124 patients harboring 144 stent-assisted coiled aneurysms were included. At least one month postembolization they underwent follow-up angiograms comprising a routine frontal and lateral DSA and a working-angle DSA. For analysis, FICs should be compared with the mask images of postprocedural DSAs to find recanalization. Instead of FIC acquisition, the mask images of follow-up DSAs were taken as a substitute because of the same view-making processes as FICs, full availability, and perfect coincidence with follow-up DSAs. Two independent readers evaluated a set of 169 FICs and DSA images for the presence of recanalization one month apart. Sensitivity, specificity, and interreader agreement were determined. Recanalization occurred in 24 (14.2%) cases. Of these, nine (5.3%) cases were found to have significant recanalization in need of retreatment. Sensitivity and specificity rates were 79.2% (19 of 24) and 95.9% (139 of 145) respectively for reader 1, and 66.7% (16 of 24) and 97.9% (142 of 145) for reader 2. Minimal recanalization was identified in seven out of all eight false negative cases. Excluding minimally recanalized cases in no need for retreatment from the recanalization group, calculation resulted in high sensitivity and specificity of over 94% for both readers. Interreader agreement between the two readers was excellent (96.4%; κ = 0.84). FICs may be a good imaging modality to detect significant recanalization of stent-assisted coiled aneurysms.

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Missed Abstracts

10.1055/s-0039-1685395 ◽

2016 ◽

Keyword(s):

Ct Scan ◽

Negative Predictive Value ◽

Predictive Value ◽

False Negative ◽

High Sensitivity ◽

Carcinoma Cervix ◽

Figo Staging ◽

Guided Biopsy ◽

Pre Treatment ◽

Sensitivity Specificity

Aim: To compare the findings of CT scan pelvis and cystoscopy findings of bladder involvement in carcinoma cervix in VIEW of revised FIGO staging and to demonstrate the accuracy of CT scan for pretreatment diagnosis of bladder involvement. Methods: A prospective and comparative study was conducted in the department of Obstetrics and Gynaecology, Rajindra hospital Patiala on a number of 100 patients of carcinoma cervix who underwent both cystoscopy and CT scan pelvis to ascertain bladder involvement. Cystoscopy guided biopsy proven cases of bladder involvement were taken as true cases of bladder involvement in the study and the results of both modalities were analysed and compared. Results: Out of 100 patients of carcinoma cervix, 28 patients showed bladder involvement on CT scan pelvis and 6 patients were proven as positive cases on cystoscopic guided bladder biopsy. The true positives in the study were 6 cases. True negatives were 94 cases. 22 patients were false positive on CT scan findings and there were no false negative patients for bladder involvement on CT scan pelvis findings in the study. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of CT scan pelvis for bladder involvement were 100%, 76.60%, 21.43%, 100% and 78% respectively. CT scan pelvis was able to detect all cases of bladder involvement which came positive cystoscopy guided biopsy as well. Conclusions: With the revised FIGO staging which has given optional status to both CT scan and cystoscopy for bladder involvement in patients of carcinoma cervix, CT scan can be used as the preliminary modality for detective bladder involvement in patients of carcinoma cervix. The high sensitivity and negative predictive value of CT scan helps choose which patients should undergo cystoscopy and helps in better and more efficient pre-treatment evaluation of patients with carcinoma cervix for bladder involvement.

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Reliability of Cobas Amplicor PCR test in detection of Mycobacterium tuberculosis in respiratory and nonorespiratory specimens

Vojnosanitetski pregled ◽

10.2298/vsp0912992l ◽

2009 ◽

Vol 66 (12) ◽

pp. 992-997

Author(s):

Zorica Lepsanovic ◽

Dejana Savic ◽

Branka Tomanovic

Keyword(s):

Mycobacterium Tuberculosis ◽

High Sensitivity ◽

High Specificity ◽

Diagnostic Methods ◽

Nucleic Acid Amplification ◽

Culture Methods ◽

Predictive Values ◽

Polymerase Chain ◽

Low Sensitivity ◽

Sensitivity Specificity

Background/Aim. Traditional methods for detection of mycobacteria, such as microscopic examination for the presence of acid-fast bacilli and isolation of the organism by culture, have either a low sensitivity and/or specificity, or take weeks before a definite result is available. Molecular methods, especially those based on nucleic acid amplification, are rapid diagnostic methods which combine high sensitivity and high specificity. The aim of this study was to determine the usefulness of the Cobas Amplicor Mycobacterium tuberculosis polymerase chain reaction (CAPCR) assay in detecting the tuberculosis cause in respiratory and nonrespiratory specimens (compared to culture). Methods. Specimens were decontaminated by the N-acetyl-L-cystein- NaOH method. A 500 ?L aliquot of the processed specimen were used for inoculation of L?wenstein-Jensen (L-J) slants, a drop for acid-fast staining, and 100 ?L for PCR. The Cobas Amplicor PCR was performed according to the manufacturer's instructions. Results. A total of 110 respiratory and 355 nonrespiratory specimens were investigated. After resolving discrepancies by reviewing medical history, overall sensitivity, specificity, and positive and negative predictive values for CA-PCR assay compared to culture, were 83%, 100%, 100%, and 96.8%, respectively. In comparison, they were 50%, 99.7%, 87.5%, and 98%, respectively, for the nonrespiratory specimens. The inhibition rate was 2.8% for respiratory, and 7.6% for nonrespiratory specimens. Conclusion. CA-PCR is a reliable assay that enables specialists to start treatment promptly on a positive test result. Lower value for specificity in a group of nonrespiratory specimens is a consequence of an extremely small number of mycobacteria in some of them.

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Dynamics of HEV Antibodies and Development of a Multi-factorial Model to Improve the Diagnosis of Current HEV Infection in Resource-limited Settings

Journal of Clinical Microbiology ◽

10.1128/jcm.02321-20 ◽

2020 ◽

Author(s):

Jie Lu ◽

Yan Huang ◽

Peiyun Wang ◽

Qing Li ◽

Ziqiang Li ◽

...

Keyword(s):

Detection Efficiency ◽

High Sensitivity ◽

High Specificity ◽

Hepatitis E ◽

Operating Characteristics ◽

Serum Samples ◽

Factorial Model ◽

Sequential Samples ◽

Sensitivity Specificity ◽

Very High

Serological markers are important for the diagnosis of hepatitis E virus (HEV) infection. This study aims to compare the diagnostic performance of the anti-HEV IgM and the HEV Antigen (Ag) assays, and establish a multi-factorial model to improve the diagnosis of current HEV infection when HEV RNA detection is not available. A total of 809 serum samples, including 325 anti-HEV IgM-positive and 484 anti-HEV IgM-negative samples, were tested for HEV RNA. The anti-HEV IgM assay had very high sensitivity (99.4%), but moderate accuracy (79.2%) and specificity (74.3%). By retrospective follow-up of 58 patients with sequential samples (n=143) tested for anti-HEV antibodies, we found anti-HEV IgM remained positive for more than 10 months in some HEV-infected patients, when HEV RNA was already undetectable; thus, decision solely based on anti-HEV IgM may lead to misdiagnosis. In contrast, the HEV Ag assay had very high specificity (100%). However, the detection efficiency of HEV Ag greatly diminished when the HEV RNA level was low or the anti-HEV IgG level was high. By logistic regression, a model integrating anti-HEV IgM, alanine aminotransferase and HEV Ag was proposed and the cut-off value was determined based on the testing results of the 143 sequential samples. The model was further evaluated with 67 randomly-selected IgM-positive samples from single-visit patients. Overall, the model outperformed the anti-HEV IgM or the HEV Ag assay in the diagnosis of current HEV infection (sensitivity/specificity/accuracy: 89.5%/95.2%/91.9%). The area under the receiver operating characteristics curve of the model was greater than 0.97.

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