• Title/Summary/Keyword: False-negative results

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Comparative Study of Target Genes and Protocols by Country for Detection of SARS-CoV-2 based on Polymerase Chain Reaction (PCR) (중합효소 연쇄반응 기반의 코로나-19 바이러스 검출법에 대한 국가별 목표 유전자 및 프로토콜 비교 연구)

  • Kim, Jin-Hee
    • The Journal of the Korea Contents Association
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    • v.21 no.1
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    • pp.465-474
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    • 2021
  • Corona-19, a disease caused by 'Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)', was declared a global pandemic by the World Health Organization (WHO) in March 2020, and a real-time polymerase chain reaction test is performed as a diagnostic test for screening and confirmation in most countries. However, not only the target genes and protocols differ by countries, but also the procedures for reading the diagnosis results are diverse, so the criteria for confirmed patients differ by country. Therefore, in this review, we discussed the target genes, test techniques, and diagnostic criteria for each country notified by WHO. And the specificity and sensitivity, limits of detection, positive and negative controls, false positive bacteria candidates, and specimens, and the specifics of the control setting were also described. In addition, the characteristics of Korea's test were compared to each country's one. Finally, in order to obtain the same diagnosis result for SARS-CoV-2 in the future, standardized diagnosis methods and result interpretations for Corona-19 diagnosis were proposed.

A Study on the Three Yin Diseases(三陰病) in the 『Shanghanlun(傷寒論)』 -Focusing on Prognosis Analysis- (『상한론(傷寒論)』 삼음병(三陰病)에 대한 연구(硏究) - 예후 분석을 중심으로 -)

  • Park, Sang-Kyun;BANG, Jung-Kyun
    • Journal of Korean Medical classics
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    • v.34 no.1
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    • pp.47-65
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    • 2021
  • Objectives : An accurate judgment of prognosis when treating diseases is crucial. While the 『Shanghanlun(傷寒論)』 deals with the prognosis of the Three Yin Diseases with great importance, full-scale studies have been lacking. This paper aims to study the Three Yin Diseases with a focus on prognosis analysis. Methods : Among the Three Yin Disease verses, those that could provide clues to prognosis were selected and analysed. Conclusions & Results : When Yang pulse patterns such as long(長脈)·floating(浮脈)·rapid(數脈) pulses and Yang symptoms such as fever, vexing heat, mild perspiration, thirst, warmth in hands and feet are present in Yin disease, it could be taken as signs of Yang Qi restoration. In these situations, Yin Cold pattern such as diarrhea and reversal cold disappear and the prognosis is positive. However, despite Yang pulse patterns and symptoms, there are cases where diarrhea happens as a result of cold dampness being eliminated due to Yang Qi restoration. Also, when Yang Qi starts communicating smoothly after its restoration in the Three Yin Diseases, perspiration can happen. When diarrhea and reversal cold, which are patterns of Yin Cold get worse, with pulse patterns such as unfelt(脈不至)·replete(實脈)·fulminating(脈暴出) pulses, false heat symptoms such as fever and hot flashes happen, accompanied with Yang Qi depleted symptoms such as inability to lie down due to agitation, continuous perspiration, sore throat, dyspnea, and exaggerated breathing happen. When fast pulse, fever, and perspiration are present due to depression and stagnation of ministerial fire, symptoms such as bloody stool with pus, purulent abscess, sore throat, and inability to lie down due to agitation show, which signal negative prognosis. In bad cases of Reverting Yin Disease, there is continuous diarrhea and bloody stool with pus, which can be due to either Kidney Yang deficiency or depression and stagnation of ministerial fire. It could also be caused by excessive heat.

Selection of suitable reference gene for gene expression studies of porcine ovaries under different conditions in quantitative reverse transcription polymerase chain reaction assay

  • Kim, Hwan-Deuk;Jeon, Hye-Jin;Jang, Min;Bae, Seul-Gi;Yun, Sung-Ho;Han, Jee-Eun;Kim, Seung-Joon;Lee, Won-Jae
    • Journal of Animal Reproduction and Biotechnology
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    • v.37 no.2
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    • pp.96-105
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    • 2022
  • The ovary undergoes substantial physiological changes along with estrus phase to mediate negative/positive feedback to the upstream reproductive tissues and to play a role in producing a fertilizable oocyte in the developing follicles. However, the disorder of estrus cycle in female can lead to diseases, such as cystic ovary which is directly associated with decline of overall reproductive performance. In gene expression studies of ovaries, quantitative reverse transcription polymerase chain reaction (qPCR) assay has been widely applied. During this assay, although normalization of target genes against reference genes (RGs) has been indispensably conducted, the expression of RGs is also variable in each experimental condition which can result in false conclusion. Because the understanding for stable RG in porcine ovaries was still limited, we attempted to assess the stability of RGs from the pool of ten commonly used RGs (18S, B2M, PPIA, RPL4, SDHA, ACTB, GAPDH, HPRT1, YWHAZ, and TBP) in the porcine ovaries under different estrus phase (follicular and luteal phase) and cystic condition, using stable RG-finding programs (geNorm, Normfinder, and BestKeeper). The significant (p < 0.01) differences in Ct values of RGs in the porcine ovaries under different conditions were identified. In assessing the stability of RGs, three programs comprehensively agreed that TBP and YWHAZ were suitable RGs to study porcine ovaries under different conditions but ACTB and GAPDH were inappropriate RGs in this experimental condition. We hope that these results contribute to plan the experiment design in the field of reproductive physiology in pigs as reference data.

Evaluation of Enzyme-linked Immunosorbent Assay in Serological Diagnosis of Human Neurocysticercosis using paired Samples of Serum and Cerebrospinal Fluid (면역효소측정법을 이용한 뇌낭미충증의 혈청학적 진단의 평가)

  • 조승열;김석일
    • Parasites, Hosts and Diseases
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    • v.24 no.1
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    • pp.25-41
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    • 1986
  • The applicability of micro-ELISA was evaluated in human neuro-cysticercosis using paired samples of serum and CSF. A total of 355 cases who were mostly neurologic patients was subjected. Cystic fluid of C. cellulosae was used as antigen in protein concentration of $2.5{\;}{\mu}g/ml$. Serum was diluted to 1 : 100 and CSF was undiluted in the assay for the specific IgG antibody level. The differential criterion of the positive reaction was the abs. of o. 18 in both samples. The results were summarized as follows: 1. The overall sensitivity of the micro-ELISA in 71 confirmed neurocysticercosis was 90.1% ; the sensitivity by serum was 77.5% and that by CSF was 83.1%. CSF was a more sensitive and valuable material. Most of the false negative cases of neuro-cysticercosis showed far lower level of abs. rather than marginal. 2. The overall specificity of the micro-ELISA in 52 confirmed other neurologic diseases was 88.5%; the specificities by serum and by CSF were 94.2% respectively. Cases of other neurologic diseases did not show false positive reactions in both samples. 3. When serum was assayed, taeniasis(2/18), sparganosis(2/20), paragonimiasis(1/56), clonorchiasis(1/15) and fascioliasis(1/1) cases showed cross reactions. When CSF was assayed, 2 ot 10 neuro-sparganosis showed cross reactions while none of 9 neuro-paragonimiasis showed it. Out of 71 confirmed neuro-cysticercosis cases, 6 and 11 showed cross reactions by serum and CSF to crude extract antigen of sparganum; but no case did show it to crude extract antigen of Paragonimus westermani. 4. Ventricular CSF showed low or negative levels of IgG antibody than lumbar CSF unless the lesion was at the lateral ventricle itself. 5. Out of 4 racemose cysticercosis cases, 3 showed positive reaction in serum while all of 3 examined CSF were positive. The above results indicated that the serological test for detecting the specific IgG antibody by micro-ELISA using paired samples of serum and CSF was very helpful for clinical differentiation of neuro-cysticercosis from neurologic diseases of other causes.

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Diagnostic testing for Duchenne/Becker Muscular dystrophy using Dual Priming Oligonucleotide (DPO) system (Dual Priming Oligonucleotide (DPO) system을 이용한 듀시엔/베커형 근이영양증 진단법)

  • Kim, Joo-Hyun;Kim, Gu-Hwan;Lee, Jin-Joo;Lee, Dae-Hoon;Kim, Jong-Kee;Yoo, Han-Wook
    • Journal of Genetic Medicine
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    • v.5 no.1
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    • pp.15-20
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    • 2008
  • Purpose : Large exon deletions in the DMD gene are found in about 60% of DMD/BMD patients. Multiplex PCR has been employed to detect the deletion mutation, which frequently generates noise PCR products due to the presence of multiple primers in a single reaction as well as the stringency of PCR conditions. This often leads to a false-negative or false-positive result. To address this problematic issue, we introduced the dual primer oligonucleotide (DPO) system. DPO contains two separate priming regions joined by a polydeoxyinosine linker that results in high PCR specificity even under suboptimal PCR conditions. Methods : We tested 50 healthy male controls, 50 patients with deletion mutation as deletion-positive patient controls, and 20 patients with no deletions as deletion-negative patient controls using DPO-multiplex PCR. Both the presence and extent of deletion were verified by simplex PCR spanning the promoter region (PM) and 18 exons including exons 3, 4, 6, 8, 12, 13, 17, 19, 43-48, 50-52, and 60 in all 120 controls. Results : DPO-multiplex PCR showed 100% sensitivity and specificity for the detection a deletion. However, it showed 97.1% sensitivity and 100% specificity for determining the extent of deletions. Conclusion : The DPO-multiplex PCR method is a useful molecular test to detect large deletions of DMD for the diagnosis of patients with DMD/BMD because it is easy to perform, fast, and cost-effective and has excellent sensitivity and specificity.

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Combination of FDG PET/CT and Contrast-Enhanced MSCT in Detecting Lymph Node Metastasis of Esophageal Cancer

  • Tan, Ru;Yao, Shu-Zhan;Huang, Zhao-Qin;Li, Jun;Li, Xin;Tan, Hai-Hua;Liu, Qing-Wei
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.18
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    • pp.7719-7724
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    • 2014
  • Background: Lymph node metastasis is believed to be a dependent negative prognostic factor of esophageal cancer. To explore detection methods with high sensitivity and accuracy for metastases to regional and distant lymph nodes in the clinic is of great significance. This study focused on clinical application of FDG PET/CT and contrast-enhanced multiple-slice helical computed tomography (MSCT) in lymph node staging of esophageal cancer. Materials and Methods: One hundred and fifteen cases were examined with enhanced 64-slice-MSCT scan, and FDG PET/CT imaging was conducted for neck, chest and upper abdomen within one week. The primary lesion, location and numbers of metastatic lymph nodes were observed. Surgery was performed within one week after FDG PET/CT detection. All resected lesions were confirmed histopathologically as the gold standard. Comparative analysis of the sensitivity, specificity, and accuracy based on FDG PET/CT and MSCT was conducted. Results: There were 946 lymph node groups resected during surgery from 115 patients, and 221 were confirmed to have metastasis pathologically. The sensitivity, specificity, accuracy of FDG PET/CT in detecting lymph node metastasis were 74.7%, 97.2% and 92.0%, while with MSCT they were 64.7%, 96.4%, and 89.0%, respectively. A significance difference was observed in sensitivity (p=0.030), but not the others (p>0.05). The accuracy of FDG PET/CT in detecting regional lymph node with or without metastasis were 91.9%, as compared to 89.4% for MSCT, while FDG PET/CT and MSCT values for detecting distant lymph node with or without metastasis were 94.4% and 94.7%. No significant difference was observed for either regional or distant lymph node metastasis. Additionally, for detecting para-esophageal lymph nodes metastasis, the sensitivity of FDG PET/CT was 72%, compared with 54.7% for MSCT (p=0.029). Conclusions: FDG PET/CT is more sensitive than MSCT in detecting lymph node metastasis, especially for para-esophageal lymph nodes in esophageal cancer cases, although no significant difference was observed between FDG PET/CT and MSCT in detecting both regional and distant lymph node metastasis. However, enhanced MSCT was found to be of great value in distinguishing false negative metastatic lymph nodes from FDG PET/CT. The combination of FDG PET/CT with MSCT should improve the accuracy in lymph node metastasis staging of esophageal cancer.

The Safety and Efficacy of Mediastinoscopy in Non-small Cell Lung Cancer (비소세포폐암에서 종격동경검사의 안전성과 유용성)

  • Park In-Kyu;Cho Sang-Ho;Kim Dae-Joon;Chung Kyung-Young
    • Journal of Chest Surgery
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    • v.39 no.6 s.263
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    • pp.470-474
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    • 2006
  • Background: Mediastinal lymph node metastasis is an important factor for staging and prognosis of non-small cell lung cancer (NSCLC), so accurate diagnosis is essential for treatment. Mediastinoscopy provides histopathological diagnosis of mediastinal lymphnode metastasis in NSCLC. The efficacy of mediastinoscopy was investigated. Material and Method: From Jun, 1999 to Aug, 2005, mediastinoscopic lymph node biopsy was performed to 348 patients with NSCLC. Patients characteristics, radiologic findings, mediastinoscopic results and pathologic stages were evaluated for investigation of safety and efficacy of modiastinoscopy in NSCLC. Result: There was 263 male and 85 female patients and the mean age was $62.1{\pm}8.5$ years. By radiologic study for mediastinal lymph node metastasis, 203 patients were negative and 145 patients were positive. Mean procedure time was $55.5{\pm}16.5$ minutes and biopsy was peformed at $2.2{\pm}1.0$ lymph node stations. There were only transient complications (1.7%) during the procedure, without other complication and mortality. There was 7.8% of false negative result in mediastinoscopy. Sensitivity (77.5% vs 71.9%, p=0.012), specificity (100% vs 74.4%, p=0.00), and accuracy (92.2% vs 73.6%, p=0.00) of mediastinoscopy were more superior than that of radiologic study for the diagnosis of mediastinal lymph node metastasis in NSCLC. Conclusion: Mediastinoscopy is a safe and effective modality for diagnosis of mediastinal lymph node metastasis in NSCLC.

Appendiceal Visualization on 2-mSv CT vs. Conventional-Dose CT in Adolescents and Young Adults with Suspected Appendicitis: An Analysis of Large Pragmatic Randomized Trial Data

  • Jungheum Cho;Youngjune Kim;Seungjae Lee;Hooney Daniel Min;Yousun Ko;Choong Guen Chee;Hae Young Kim;Ji Hoon Park;Kyoung Ho Lee;LOCAT Group
    • Korean Journal of Radiology
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    • v.23 no.4
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    • pp.413-425
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    • 2022
  • Objective: We compared appendiceal visualization on 2-mSv CT vs. conventional-dose CT (median 7 mSv) in adolescents and young adults and analyzed the undesirable clinical and diagnostic outcomes that followed appendiceal nonvisualization. Materials and Methods: A total of 3074 patients aged 15-44 years (mean ± standard deviation, 28 ± 9 years; 1672 female) from 20 hospitals were randomized to the 2-mSv CT or conventional-dose CT group (1535 vs. 1539) from December 2013 through August 2016. A total of 161 radiologists from 20 institutions prospectively rated appendiceal visualization (grade 0, not identified; grade 1, unsure or partly visualized; and grade 2, clearly and entirely visualized) and the presence of appendicitis in these patients. The final diagnosis was based on CT imaging and surgical, pathologic, and clinical findings. We analyzed undesirable clinical or diagnostic outcomes, such as negative appendectomy, perforated appendicitis, more extensive than simple appendectomy, delay in patient management, or incorrect CT diagnosis, which followed appendiceal nonvisualization (defined as grade 0 or 1) and compared the outcomes between the two groups. Results: In the 2-mSv CT and conventional-dose CT groups, appendiceal visualization was rated as grade 0 in 41 (2.7%) and 18 (1.2%) patients, respectively; grade 1 in 181 (11.8%) and 81 (5.3%) patients, respectively; and grade 2 in 1304 (85.0%) and 1421 (92.3%) patients, respectively (p < 0.001). Overall, undesirable outcomes were rare in both groups. Compared to the conventional-dose CT group, the 2-mSv CT group had slightly higher rates of perforated appendicitis (1.1% [17] vs. 0.5% [7], p = 0.06) and false-negative diagnoses (0.4% [6] vs. 0.0% [0], p = 0.01) following appendiceal nonvisualization. Otherwise, these two groups were comparable. Conclusion: The use of 2-mSv CT instead of conventional-dose CT impairs appendiceal visualization in more patients. However, appendiceal nonvisualization on 2-mSv CT rarely leads to undesirable clinical or diagnostic outcomes.

Clinical Significance of Tumor Markers in Gastric Cancer Patients after Curative Resection (근치적 절제술을 시행한 위암 환자에서 종양 표지자의 임상적 의미)

  • Kim, Sa-Young;Ha, Tae-Kyung;Kwon, Sung-Joon
    • Journal of Gastric Cancer
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    • v.9 no.3
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    • pp.136-142
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    • 2009
  • Purpose: This clinical study was conducted to evaluate the predictive value of tumor markers for recurrence and the clinical significance of false positive findings after curative gastrectomy in patients with gastric cancer. Materials and Methods: Two hundred ninety patients with gastric cancer who underwent gastrectomy with curative intent were evaluated retrospectively. We analyzed the correlations between changes in tumor markers (CEA, CA 19-9, AFP, and CA-125) and clinicopathologic data, and basis for changes in tumor markers without recurrence during the follow-up period. Results: The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of tumor markers for recurrence were 75.0%, 64.6%, 23.1%, 94.8%, and 65.9% respectively. Among 36 patients with recurrences, 10 patients (27.8%) had elevated tumor markers prior to positive findings on imaging studies, while 13 patients (36.1%) had concomitant elevation in tumor markers. At least 1 of the 4 tumor markers increased in 90 of 290 patients during the follow-up period; however, there was no evidence of tumor recurrence. Twenty patients had persistently elevated tumor markers, while the tumor marker levels in 70 patients returned to normal level within $9.08\pm7.2$ months. The patients with pulmonary disease, hepatobiliary disease, diabetes, hypertension, or herbal medication users had elevated tumor markers more frequently than patients without disease (P<0.001). Conclusion: Although detecting recurrence of gastric cancer with tumor markers may be useful, false positive findings of tumor markers are common, so surgeons should consider other chronic benign diseases and medical conditions when tumor markers increase without evidence of recurrence.

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Diagnostic and Therapeutic Utility of Ultrasonography-guided Facet Joint Block in Chronic Cervical Spinal Pain (만성 경추 동통 환자에서 초음파를 이용한 후관절 차단술의 진단 및 치료적 유용성)

  • Kim, Tae Kyun;Shim, Dae Moo;Oh, Sung Kyun;Choi, Byong San;Han, Sang Su
    • The Journal of Korean Orthopaedic Ultrasound Society
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    • v.3 no.2
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    • pp.54-58
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    • 2010
  • Purpose: In patients with chronic cervical pain, the facet joint is the source of the majority. Due to the difficulty of identifying the exact location of the joint that causes these symptoms, the possibility of complications and the placebo effect brings clinical application into question. In this study, we assessed the prevalence of patients with chronic cervical pain and report the diagnostic and therapeutic usefulness of ultrasonography - guided facet joint block therapy. Materials and Methods: Patients with nonspecific chronic cervical pain for more than 6 months were selected. Patients with disc herniation, sciatica-related pain were excluded from the study and 160 patients who failed in conservative treatment (physical therapy, chiropractic therapy, medication) were included in the study. Diagnostic Ultrasonography-guided facet joint block was performed with 1% lidocaine, and after two weeks, Bupivacaine 0.25% was used in patients who tested positive for lidocaine. Patients with more than 75% pain reduction during movement after facet joint block were considered positive. Results: Among the 160 patients with chronic cervical pain, 96 patients(60%) had a positive reaction after facet block using lidocaine. Among the 64 patients with a negative reaction to lidocaine, 48 patients(75%) had a positive reaction to bupivacaine. There were 48 false positive patients(50%) who showed a positive reaction to lidocaine but a negative reaction to bupivacaine. The mean VAS of the total 160 patients before blocks was 8.5, after 2 weeks follow up it decreased to 2.7 (p = 0.001) and after 4weeks 3.6 (p = 0.001). The 8 patients as an initial improvement of symptoms are not satisfied with the procedure and the 3 patients had been worsened during observation, were showed pain relief after additional ultrasonography-guided facet joint block at 4th week. Conclusion: A single ultrasonography-guided block to chronic cervical pain patients has relatively low diagnostic value since high false positive rate. The twice facet joint blocks is thought to be a useful method for interventional pain management of patients with chronic cervical pain.

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