• Tuberculosis and Respiratory Diseases
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• 제84권3호
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• pp.226-236
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• 2021

Background: Although the Quidel Sofia rapid influenza fluorescent immunoassay (FIA) is widely used to identify influenza A and B, the diagnostic accuracy of this test remains unclear. Thus, the objective of this study was to determine the diagnostic performance of this test compared to reverse transcriptase-polymerase chain reaction. Methods: A systematic literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register. Pooled sensitivity, specificity, diagnostic odds ratio (DOR), and a hierarchical summary receiver-operating characteristic curve (HSROC) of this test for identifying influenza A and B were determined using meta-analysis. A sensitivity subgroup analysis was performed to identify potential sources of heterogeneity within selected studies. Results: We identified 17 studies involving 8,334 patients. Pooled sensitivity, specificity, and DOR of the Quidel Sofia rapid influenza FIA for identifying influenza A were 0.78 (95% confidence interval [CI], 0.71-0.83), 0.99 (95% CI, 0.98-0.99), and 251.26 (95% CI, 139.39-452.89), respectively. Pooled sensitivity, specificity, and DOR of this test for identifying influenza B were 0.72 (95% CI, 0.60-0.82), 0.98 (95% CI, 0.96-0.99), and 140.20 (95% CI, 55.92-351.54), respectively. The area under the HSROC for this test for identifying influenza A was similar to that for identifying influenza B. Age was considered a probable source of heterogeneity. Conclusion: Pooled sensitivities of the Quidel Sofia rapid influenza FIA for identifying influenza A and B did not quite meet the target level (≥80%). Thus, caution is needed when interpreting data of this study due to substantial betweenstudy heterogeneity.

• Maxillofacial Plastic and Reconstructive Surgery
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• 제33권3호
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• pp.286-291
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• 2011

Purpose: The purpose of this study was to evaluate the use of OraQuick tests in previously reported articles. Methods: The literature was searched using Pubmed Medline with keywords, such as "OraQuick" or "rapid HIV test". Articles that included the specificity and sensitivity of this device were reviewed. Results: A total of 11 journal articles including 3 domestic articles were reviewed. The sensitivity of the OraQuick Test was reported to be 97.8 to 100% and its specificity was 98.8 to 100%. Conclusion: The results indicated that the simple OraQuick assay has proven to be accurate and it can be used to detect patients with HIV and to prevent the spread of HIV on test screens.

• 한국임상수의학회지
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• 제32권1호
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• pp.73-77
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• 2015

There has been increasing attention on sample size requirements in peer reviewed medical literatures. Accordingly, a statistically-valid sample size determination has been described for a variety of medical situations including diagnostic test accuracy studies. If the sample is too small, the estimate is too inaccurate to be useful. On the other hand, a very large sample size would yield the estimate with more accurate than required but may be costly and inefficient. Choosing the optimal sample size depends on statistical considerations, such as the desired precision, statistical power, confidence level and prevalence of disease, and non-statistical considerations, such as resources, cost and sample availability. In a previous paper (J Vet Clin 2012; 29: 68-77) we briefly described the statistical theory behind sample size calculations and provided practical methods of calculating sample size in different situations for different research purposes. This review describes how to calculate sample sizes when assessing diagnostic test performance such as sensitivity and specificity alone. Also included in this paper are tables and formulae to help researchers for designing diagnostic test studies and calculating sample size in studies evaluating test performance. For complex studies clinicians are encouraged to consult a statistician to help in the design and analysis for an accurate determination of the sample size.

• 한국임상수의학회지
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• 제33권2호
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• pp.97-101
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• 2016

In the field of clinical medicine, diagnostic accuracy studies refer to the degree of agreement between the index test and the reference standard for the discriminatory ability to identify a target disorder of interest in a patient. The receiver operating characteristic (ROC) curve offers a graphical display the trade-off between sensitivity and specificity at each cutoff for a diagnostic test and is useful in assigning the best cutoff for clinical use. In this end, the ROC curve analysis is a useful tool for estimating and comparing the accuracy of competing diagnostic tests. This paper reviews briefly the measures of diagnostic accuracy such as sensitivity, specificity, and area under the ROC curve (AUC) that is a summary measure for diagnostic accuracy across the spectrum of test results. In addition, the methods of creating an ROC curve in single diagnostic test with five-category discrete scale for disease classification from healthy individuals, meaningful interpretation of the AUC, and the applications of ROC methodology in clinical medicine to determine the optimal cutoff values have been discussed using a hypothetical example as an illustration.

• Child Health Nursing Research
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• 제11권3호
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• pp.316-321
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• 2005

Purpose: This study was done to evaluate the validity of Korean Denver ll developmental screening test in screening children with developmental risk. Method: The participants in the study were 113 children referred for developmental assessment in the department of rehabilitation of D University hospital. They were examined with the BSID (Bayley Scales of Infant Development) II and Korean Denver II by one occupational therapist. The data was analyzed by $x^2$ test and discriminant analysis. Results: There was a significant relationship between the Mental Developmental Index (MDI) of the BSID II and the result of the Korean Denver II. The sensitivity and specificity of Korean Denver II were 0.87 and 0.62 when abnormal MDI was defined as lower than 85 was used as a diagnosis of developmental delay. There was a significant relationship between the Psychomotor Developmental Index (PDI) of the BSID ll and the result 0.7 Korean Denver ll. The sensitivity and specificity of Korean Denver II were 0.83 and 0.51 The over-all hit ratio was $79.6\%$. Conclusion: The result showed that the Korean Denver II was valid and has good sensitivity and moderate specificity in screening developmental delay.

• 응용통계연구
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• 제20권3호
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• pp.515-530
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• 2007

진단검사에서 민감도와 특이도가 선택편향에 영향을 받을 때, 진단검사의 각층에서의 민감도와 1-특이도의 비로 얻어지는 층화우도비도 편의가 존재하게 된다. 따라서 편의가 있는 층화우도비로 찾아진 최적절사점도 잘못된 값이 된다. 본 연구에서는 Begg과 Greenes (1983)에 의해 제안된 수정 민감도와 특이도를 층화우도비에 적용하여, 선택편향이 수정되는 최적절사점을 찾아보았다. 그리고 선택편향이 최적절사점에 미치는 영향을 선택편향 수정인자를 통해 설명하였다.

• Journal of Yeungnam Medical Science
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• 제8권1호
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• pp.42-52
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• 1991

최근 널리 사용되고 있는 제조회사가 다른 두가지 요시험지봉(Combur-9-test$^{(R)}$ RL & Multistix$^{(R)}$-SG)으로 요검사를 실시하면, 그 결과치의 표현에 있어 차이가 있으므로, 결과치 판정시 질병의 진단이나 치료의 효과 판정 및 경과관찰에 있어서 발생할 수 있는 혼란을 줄이고자, 환자검체와 표준검체에서 실시한 요시험지봉 검사결과를 비교 검토하여 아래와 같은 결론을 얻었다. 또한 두 시험지봉검사에 결과를 교환함에 있어 상응하는 결과치도 조사하였다. Combur-9-test RL 및 Multistix-SG를 이용하여, 1990년 12월 16일 부터 15일간 영남대학교 의과대학 부속병원 임상병리과에 요검사가 의뢰된 501명의 환자검체를 대상으로 하여 요시험지봉으로 화학적검사를 반정량적으로 시행한 결과 대체로 ${\pm}1$등급 범위내에서 일치하였다. Combur-9-test RL을 이용한 leukocyte esterase 검사와 요침사검사간의 비교에서 현미경적 농뇨와의 일치율은 83.7%, 민감도 48.1%, 특이도 90.3%, 양성예측율 47.4% 및 음성예측율 90.5%로 나타났다. Combur-9-test RL을 사용한 nitrite검사와 요배양검사간의 비교에서 요배양 양성과의 일치율은 93.0%, 민감도 19.4%, 특이도 84.7%, 양성예측율 53.8% 및 음성예측율 94.1%로 나타났다. 단백의 주 성분이 알부민 및 글로부린인 검체에서 실시한 요단백검사에서는 양자 모두에서 sulfosalicylic acid 법이 가장 민감하였고, 다음은 Multistix-SG, Combur-9-test RL의 순이었다. 요빌리루빈 및 요당검사에서는 두시험지봉이 비슷한 민감도를 나타내었다. 요중 백혈구검사에서는 요침사검사가, 요중 잠혈검사에서는 Combur-9-test RL이 가장 민감하였다.

• 대한세포병리학회지
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• 제19권2호
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• pp.107-110
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• 2008

We evaluated the usefulness of cervicovaginal cytology as a primary screening test by analyzing the cytologic and histological diagnoses of 2,254 women. Cervicovaginal cytology had 93.0% sensitivity, 86.1% specificity, 88.2% positive predictive value, and 91.7% of negative predictive value. Cervicovaginal cytology as a primary screening test showed much higher specificity but slightly lower sensitivity than HPV DNA testing. However, the sensitivity of cervicovaginal cytology will be improved continuously due to the development of liquid-based cytology. We regard cervicovaginal cytology as a good primary screening test for cervical intraepithelial neoplasia or carcinoma.

• 한국환경보건학회지
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• 제34권5호
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• pp.369-373
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• 2008

The indoor environment is an important source of exposure to various aeroallergens and pathogenic microorganism. It has been shown that exposure to aeroallergens enhances the risk of indoor inhabitants developing asthma. Since the skin prick test, a typical clinical method for identification of subjects positive to allergens, can rarely cause fatal or non-fatal reactions in susceptible persons, an in vitro assay such as ELISA using serum has been considered for testing positivity against various allergens. We evaluated the validity of a serum ELISA kit for screening positive subjects to major aeroallergens including Dermatophagoides farinae, Dermatophagoides pteronyssinus, cockroach, Alternaria, Cladosporium, Aspergillus, Penicillium, dog hair, cat fur, mugwort, and ragweed. The ELISA results were compared with the skin prick test results, and sensitivity, specificity, and overall accuracy were calculated to each allergen. Higher sensitivities were obtained from D. farinae, (77.8%) and D. pteronyssinus (69.2%), but sensitivities to Aspergillus, Penicillium, dog hair, cat fur, and ragweed were very low down to 0%. Specificity ranged from 88.7% (cat fur) to 100% (mugwort and ragweed). Overall the accuracy of the serum ELISA kit was relatively high, in that the lowest was 85.1% for cat fur and the highest was 98.6% for Alternaria, Cladosporium, and ragweed. Considering specificity and overall accuracy for the serum ELISA kit, it may be considered reliable. However, when the kit is used for screening purpose, positivity to aeroallergens should be carefully determined since sensitivity for the kit is low.

• Journal of Nutrition and Health
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• 제33권8호
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• pp.864-872
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• 2000

This study intended to evaluate the validity of the simple nutrition screening test that had been developed with the elderly living in Cheongju as a subject. Nutrition screening score(NSS) and reference standards for nutritional and health status(nutrient intakes, mean adequacy ratio, perceive health, and serum albumin, hematocrit, and hemoglobin) were estimated by using the date obtained in 1996 from the 174 elderly living in Taejon, Statistical analysis showed significant correlations between mean adequacy ratio(MAR) and NSS(r=0.341) and also between NSS and biological indices such as albumin and hematocrit, Around 65-75% of the elderly with perceive health and low level of serum albumin, hemoglobin and hematocrit had NSS$\leq$ll. Sensitivity, specificity, and positive predictive values(PPV) were calculated from the crosstabulation of the three categories of NSS(high, moderate, and low nutritional risk) and low categories MAR(< 0.75, undernutrition;$\geq$0.75, normal) to validate the cut-off point for high or low nutritional risk by NSS. It was suggested that point l1 was appropriate as a criterion to determine high risk of undernutrition, but point 16 was better than 17 as criterion to determine low nutritional risk in the Taejon elderly. When point ll was used as a criterion of high nutritional risk, sensitivity, specificity, and PPV are 59.5, 60.5 and 82.1 respectively. When point 16 was used as a criterion of low nutritional risk, sensitivity, specificity, and PPV are 25.6, 95.4, and 64.7%, respectively. In conclusion, nutrition screening test that had been developed can be a simple, easy, and proper instrument to classify the high risk group of undernutrition. A further validation study seems to be required among other groups of individuals for the screening test to the finalized as a more valid instrument identifying Korean elderly at nutrition and health risk(Korean J Nutrition 33(8) : 864-872, 2000)