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1 신종인플루엔자 A(H1N1) 관련 에스디신속진단시약의유용성 FAQs about novel Influenza A(H1N1) and use of SD Influenza Ag Rapid Test ( 주 ) 에스디 STANDARD DIAGNOSTICS, INC. 경기도용인시기흥구하갈동 TEL: / FAX: Marketing Dept.

2 [ 신종플루관련에스디신속진단시약의유용성 ] 인플루엔자신속진단시약의유용성 에스디인플루엔자신속진단시약은콧물을이용하여현장에서간편하게인플루엔자바이러스 A타입과 B타입감염여부를 20분내에진단할수있도록제작된제품입니다. 현재판매되는제품은신종인플루엔자 A(H1N1) 과계절성 A형인플루엔자를감별진단할수는없으나, 미국과일본의경우신종플루의확산방지와조기진단을위하여, 의심환자에대해신속진단검사를우선실행할것을권고하고있습니다. 정확한검진을위해모든의심환자에대해 RT-PCR 검사를진행하는것이바람직하나, 1) PCR 검사결과확인시까지 1일 ~3일이소요되어, 그기간동안주변인에대한 2차확산이우려됩니다. 2) 신종플루로인한사망자의경우증세후 5일만에숨져, 의료기관의초기대응이매우중요합니다. 의심환자의경우확진검사의뢰뿐만아니라신속진단검사를즉시실행하고적절한처방을선행하여야합니다. 3) 8월 18일부로 PCR에대한보험을확대적용한다고하나, 지역감염이빠른속도로확산되고있고, 불안한마음에병원을찾은환자들이고액의비용에검사를하지못해, 감염환자를놓치는일이생길수도있습니다. 4) 미국 CDC의경우 신종인플루엔자유행국가에서는, 신속진단키트검사에서양성결과를나타낸환자에게추가확진검사없이도치료제를처방할수있다 고발표하였고, 마찬가지로일본에서도 급성호흡기증상이있는환자에대한 1차검사로인플루엔자신속진단키트를우선실행할것을권고 하고있습니다. 신종인플루엔자의확산을차단하기위한방법은조기진단및조기치료입니다. 신속진단키트를 이용한빠른진단과조기치료로신종플루의확산을예방하는하는것이매우중요합니다. 에스디의인플루엔자신속진단시약은 Nasal swab 이나 Throat swab 을이용해간편하게검사할수있습니다. 여러논문을통해높은민감도와특이도를입증하였고, 신종인플루엔자 A(H1N1) 를검출할수있음이확인되었습니다. WHO에서신종플루에대한신속진단시약의검출능력을평가하기위해, 전세계에서단 6개업체제품만을평가중에있는데, 당사에스디인플루엔자신속진단시약이당당히포함되어있습니다. ( 에스디및일본제품 2종, 미국제품 3종, 총 6종의제품 ) 또한 콧물을이용해신종플루를 15 분내에검출할수있는신속진단시약 을 질병관리본부와함께개발하는내용의연구개발계약을완료하여, 조만간 신종플루 신속진단시약 을선보일예정입니다. 에스디 STANDARD DIAGNOSTICS, INC.

3 [ 신종플루관련에스디신속진단시약의유용성 ] 신종인플루엔자 A(H1N1) 검사시간비교 급성호흡기환자내원 콧물검체채취및 신속진단시약검사 20분 결과확인및처방 검체채취및검사의뢰 RT-PCR 검사 2일 (48시간) 결과확인 환자재방문및처방 치료제 ( 항바이러스제 ) 처방 신종인플루엔자 A(H1N1) 과계절성인플루엔자의치료제는동일합니다. Oseltamivir : 로슈 타미플루 Zanamivir : GSK 리렌자 따라서신종플루의확산을막기위해, 신속진단시약으로즉시검사를시행하고양성환자에대한 치료제처방후, 신종플루확진을위해확진검사 (RT-PCR) 을진행하시는것이좋습니다. 에스디 STANDARD DIAGNOSTICS, INC.

4 [ 신종플루관련에스디신속진단시약의유용성 ] 신종인플루엔자 A(H1N1) 검사비용비교 1. RT-PCR 검사비용 Real time or Multiplex RT-PCR RT-PCR 검사기관 수가 1) 환자본인부담금 수가 1) 환자본인부담금 입원외래입원외래 의원 117,250 23,450 35,170 42,190 8,430 12,650 병원 122,350 24,470 48,940 44,030 8,800 17,610 종합병원 127,450 25,490 63,720 45,860 9,170 22,930 종합전문요양기관 132,550 26,510 79,530 47,700 9,540 28,620 검사의뢰시 112,160 진료받는요양기관 종별에따라산정 40,360 진료받는요양기관 종별에따라산정 1) 종별가산적용 건강보험인정기준대상환자 급성열성호흡기질환이있으면서, - 입원중인환자 ( 응급실환자포함 ) - 신종인플루엔자고위험군환자 59개월이하의소아, 임산부, 65세이상노인, 만성질환이있는사람 개인보호장구없이전염력이있는추정, 확진환자를진료한의료인 - 신종인플루엔자A(H1N1) 진단기준의의심사례, 추정환자또는지역사회감염이의심되는경우등의사가검사필요성을인정한경우 상기급여기준이외시행하는경우의검사비용은전액을환자가부담함 2. 신속진단시약검사비용 : 건강보험요양급여비용코드번호 [CZ-394 인플루엔자 A B 바이러스항원검사 ( 현장검사 )] : 환자부담금약 2 만원 에스디 STANDARD DIAGNOSTICS, INC.

[ 신종플루관련에스디신속진단시약의유용성 ] 신속진단시약의적절한사용시기 미국질병관리본부(CDC) 의발표에따르면,

그러나이는신속진단시약의적절한사용시기를고려하지않았기때문으로, WHO 의권고사항에따르면,

어린아이들의경우바이러스농도의감소의시기가더길어질수있어증상발현후 5 일이후에검체를채취해검사해도유용합니다.

가 nasal swabs, throat swabs 보다좀더유용하게쓰일수있습니다.

diagnosiss (July 2005) 2) W 이는인플루엔자감염에따른증상추이그래프 ( 아래표 )

5 [ 신종플루관련에스디신속진단시약의유용성 ] 신속진단시약의적절한사용시기 미국질병관리본부(CDC) 의발표에따르면, 신속진단시약제품들의민감도는기대보다낮은수준으로보고되고있습니다. 그러나이는신속진단시약의적절한사용시기를고려하지않았기때문으로, WHO 의권고사항에따르면, 성인의경우시간이지날수록바이러스농도가감소하기때문에검체를채취하는시점은증상이발현되는시점에서 4-5 일이내여야하고, 어린아이들의경우바이러스농도의감소의시기가더길어질수있어증상발현후 5 일이후에검체를채취해검사해도유용합니다. 또한더나은검사결과를얻기위해서는세포성물질을포함하고있는 nasal aspirates, nasopharyngeal swabs 가 nasal swabs, throat swabs 보다좀더유용하게쓰일수있습니다. 2) WHO recommendations on the use of rapid testing for influenza diagnosiss (July 2005) 2) W 이는인플루엔자감염에따른증상추이그래프 ( 아래표 ) 에서도확인할수있습니다. 따라서신속진단시약은급성호흡기질환증상이나타난후가급적 2~3 일이내에검사하여야만유용한결과를나타냅니다. 증상발현 3 일이후검사시에는바이러스가급감함에따라신속진단시약에서음성결과가나타날수있음을유의하여야합니다. 신속진단시약검출가능시기 에스디 STAN DARD D IAGNOSTICS, IN C.

[ 신종플루관련에스디신속진단시약의유용성 ] 타사신속진단시약과의비교평가 미국질병관리본부에서는지난 4 월신종플루발병이후채집된 65 개호흡기샘플을대상으로미국내시판중인 'BinaxNow 와벡튼디킨슨사의 'EZ 플루 A+B, 퀴델사의 'Quickvue 등 3 개진단테스트의효능을시험했습니다.

6 [ 신종플루관련에스디신속진단시약의유용성 ] 타사신속진단시약과의비교평가 미국질병관리본부에서는지난 4 월신종플루발병이후채집된 65 개호흡기샘플을대상으로미국내시판중인 'BinaxNow 와벡튼디킨슨사의 'EZ 플루 A+B, 퀴델사의 'Quickvue 등 3 개진단테스트의효능을시험했습니다. 시험결과 H1N1 바이러스검출비율이 BinaxNow 가 40% 로가장낮았고 Quickvue 는 69%, EZ 플루 A+B 는 49% 를각각기록했습니다. 하지만기존의논문에서보면, 에스디인플루엔자신속진단시약은세계유수제품들과의비교평가에서높은민감도를보여주었습니다. 다음의임상평가결과를참조하십시오. ( 논문별첨 ) 에스디 STANDARD DIAGNOSTICS, INC.

13 CLINICAL AND VACCINE IMMUNOLOGY, Aug. 2007, p Vol. 14, No /07/$ doi: /cvi Copyright 2007, American Society for Microbiology. All Rights Reserved. Clinical Evaluation of the SD Bioline Influenza Virus Antigen Test for Rapid Detection of Influenza Viruses A and B in Children and Adults during the Influenza Season Young Yoo, 1 Jang Wook Sohn, 2 Dae Won Park, 2 Jeong Yeon Kim, 2 Hye Kyung Shin, 1 Yoon Lee, 1 Ji Tae Choung, 1 Chang Kyu Lee, 3 and Min Ja Kim 2,4 * Department of Pediatrics, 1 Division of Infectious Diseases, Department of Internal Medicine, 2 and Department of Laboratory Medicine, 3 College of Medicine, and Institute of Emerging Infectious Diseases, 4 Korea University, Seoul, Korea Received 6 December 2006/Returned for modification 13 March 2007/Accepted 4 June 2007 The performance of the SD Bioline rapid antigen test kit for influenza virus detection was evaluated with 295 respiratory specimens during the influenza season. The overall sensitivity and specificity of the SD Bioline test were 61.9% and 96.8% for the influenza A virus antigen and 54.5% and 100% for the influenza B virus antigen, respectively. The results were consistent with peak influenza activities. * Corresponding author. Mailing address: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, no , Anam-dong 5-ga, Seongbuk-gu, Seoul , Korea. Phone: Fax: Published ahead of print on 13 June Influenza viruses are responsible for epidemics resulting in morbidity and excess mortality among the very young, the elderly, and those with chronic illness (10, 11). The rapid and accurate detection of influenza viruses is essential for appropriate antiviral therapy early in the illness and contributes to the reduction of medical costs and the lengths of hospital stays (5). Recently developed rapid influenza tests have had a positive impact on medical management by decreasing the need for ancillary tests and the use of antibiotics in children evaluated for an influenza-like illness in an emergency department (4, 12). Furthermore, they have increasingly become a useful tool for the surveillance of influenza activity (7, 13, 16). Several rapid influenza antigen detection kits using enzyme, optical, or chromatographic immunoassays provide a result in 15 to 30 min, with reported sensitivities ranging from 62% to 85% and specificities ranging from 79.5% to 99% compared to viral cultures (1, 14). A newly developed SD Bioline rapid influenza test (Standard Diagnostics, Inc., Suwon, Korea) is a lateral-flow immunoassay that uses influenza virus-specific monoclonal antibodies on a strip for the qualitative detection of influenza A and B virus antigens, separately. However, the performance of the test has not been determined to date. In this study, we compared the performance of the SD Bioline test with that of the QuickVue test (Quidel Corp., San Diego, CA), a nontyping lateral-flow immunoassay (3) which is currently the only rapid influenza test available in Korea, and further evaluated its clinical usefulness during the influenza season. The study population was comprised of 295 Korean children and adults who were admitted to or visited the outpatient clinics at Korea University Anam Hospital with symptoms of acute respiratory tract illness during the 2005-to-2006 influenza season. Demographic and clinical data were collected using case report forms. Written informed consent to participate in the study was obtained from patients or their parents. The study protocol was approved by the hospital ethics committee (approval no. AN0560). Three anterior nasal or throat swab specimens per adult patient were collected. One swab, for virus culture, was transferred in standard refrigerated HH medium (Hanks balanced salt solution with 0.88% sodium bicarbonate, 0.2% bovine serum albumin [Sigma], 30 mm HEPES buffer, and 50 g/ml gentamicin [9]), and the other two swabs were used for rapid influenza virus antigen testing. Nasopharyngeal aspirates and two throat swabs collected from each pediatric patient were used for virus culture and the influenza virus antigen tests, respectively. The specimen for culture was immediately placed in 2 ml of HH medium after the collection, transported to the virus laboratory on ice, and kept at 20 C until the culture was performed. Virus culture was performed using the cryopreserved R-Mix cultures (Diagnostic Hybrids, Inc., Athens, OH), as previously described (2, 8). The QuickVue and SD Bioline tests were run in parallel. Four physicians (two pediatric and two infectious disease doctors) performed the tests, as described in the package inserts, at bedside or at the outpatient clinic throughout the study period. Briefly, both tests involved the extraction of influenza TABLE 1. Characteristics of the study population Characteristic Children Value for: Adults No. of patients (no. of males/ 174 (94/80) 121 (56/65) no. of females) Age, yr (range) a 4.8 ( ) 48.0 ( ) No. (%) of patients hospitalized 112 (64.6) 62 (51.2) Duration of hospitalization, 5 (2 11) 12 (2 205) days (range) a Duration of fever, days (range) a 2 (1 21) 3 (1 36) Interval between fever onset and testing, days (range) a 2 (1 13) 4 (1 27) a Differences were considered statistically significant at a P of Downloaded from cvi.asm.org at KOREA UNIV. on August 7,

14 VOL. 14, 2007 NOTES 1051 Rapid test and virus detected Rapid test positive, culture positive TABLE 2. Performance of two rapid tests for the detection of influenza viruses No. of specimens that were: Rapid test positive, culture negative Rapid test negative, culture positive Rapid test negative, culture negative Sensitivity (%) Specificity (%) Predictive value (%) SD Bioline test Influenza A virus Influenza B virus QuickVue test Positive Negative virus antigens from the patients specimens. Each swab specimen was placed in a tube containing an extraction agent provided in each test kit. After the disruption of the viral particles, a test strip from each test kit was placed in the extraction tube and allowed to react with the influenza virus-specific monoclonal antibodies for 10 to 30 min. In the SD Bioline test, a pink-to-purple test line in the A or B region with the presence of a purple control line indicates a positive result for influenza virus A or B, respectively. With the QuickVue test, a pink-tored test line in the presence of a blue control line indicates a positive result (3). Data are represented as medians (ranges), unless otherwise indicated. The variables or frequencies were compared between the two groups using the Student t test or the chi-square test. Viral cultures positive for influenza virus A or B were considered true positives. All data analyses were performed using SPSS version 12.0 (SPSS, Inc., Chicago, IL). The clinical characteristics of the study population are shown in Table 1. Among the 295 patients tested, overall detection rates for the virus culture, the QuickVue test, and the SD Bioline test were 25.4%, 15.9%, and 17.6%, respectively. Although the sensitivities and the specificities of the SD Bioline test were somewhat higher than those of the QuickVue test, none of these differences was significant (Table 2). Both tests were simple and easy to perform at bedside, but the SD Bioline test showed somewhat slow color development compared to the QuickVue test. There were two outbreaks of local influenza activity reported by the Korean Influenza Surveillance Scheme (KISS), Korean Center for Disease Control and Prevention. The first outbreak (the 52nd week of 2005) was due to influenza virus type A, and the second outbreak (the 17th week of 2006) was due mainly to the type B virus (Fig. 1). The sensitivities of the QuickVue test and the SD Bioline test rose to 67.6% and 70.3% during the first outbreak and 37.9% and 62.1% during the second outbreak, respectively. However, the SD Bioline test showed an unacceptably low positive predictive value when the virus prevalence was low, suggesting its limitation as a screening program outside the influenza season. In this study, the SD Bioline test showed excellent specificity Downloaded from cvi.asm.org at KOREA UNIV. on August 7, 2007 FIG. 1. Detection of influenza viruses by culture and by the SD Bioline rapid antigen test in conjunction with an epidemic curve with two peaks of influenza activity based on the report from the KISS for the 2005-to-2006 season., influenza A reported by the KISS;, influenza B reported by the KISS;, influenza A virus detected by culture;, influenza B virus detected by culture;, influenza A virus detected by the SD Bioline test;, influenza B virus detected by the SD Bioline test.

15 1052 NOTES CLIN. VACCINE IMMUNOL. for the detection of the influenza A and B viruses and fair-togood sensitivities, compared to those of other studies of rapid influenza tests (1, 14). Differences in the specimen collection methods and the age of the study population are the likely explanation. It has been reported that nasopharyngeal aspirates are superior to nasal or throat swabs for the detection of influenza viruses by rapid antigen testing (6). Anterior nasal or throat swabs were easier and faster to collect and were mostly preferred by the adult patients, which might contribute to the lower sensitivities in this study. In addition, lower quantities of virus shedding have been reported for older patients than for children (15). In conclusion, the SD Bioline rapid influenza test is useful for detecting influenza virus type A and type B. Within the recognized limitations, it might be a part of influenza surveillance programs for the influenza season. This study was financially supported in part by Standard Diagnostics, Inc., Suwon, Korea, and in part by City of Seoul grant no REFERENCES 1. Agoritsas, K., K. Mack, B. K. Bonsu, D. Goodman, D. Salamon, and M. J. Marcon Evaluation of the Quidel QuickVue test for detection of influenza A and B viruses in the pediatric emergency medicine setting by use of three specimen collection methods. J. Clin. Microbiol. 44: Barenfanger, J., C. Drake, T. Mueller, T. Troutt, J. O Brien, and K. Guttman R-Mix cells are faster, at least as sensitive and marginally more costly than conventional cell lines for the detection of respiratory viruses. J. Clin. Virol. 22: Bellei, N., D. Benfica, A. H. Perosa, R. Carlucci, M. Barros, and C. Granato Evaluation of a rapid test (QuickVue) compared with the shell vial assay for detection of influenza virus clearance after antiviral treatment. J. Virol. Methods 109: Bonner, A. B., K. W. Monroe, L. I. Talley, A. E. Klasner, and D. W. Kimberlin Impact of the rapid diagnosis of influenza on physician decision-making and patient management in the pediatric emergency department: results of a randomized, prospective, controlled trial. Pediatrics 112: Cazacu, A. C., J. Greer, M. Taherivand, and G. J. Demmler Comparison of lateral-flow immunoassay and enzyme immunoassay with viral culture for rapid detection of influenza virus in nasal wash specimens from children. J. Clin. Microbiol. 41: Chan, K. H., N. Maldeis, W. Pope, A. Yup, A. Ozinskas, J. Gill, W. H. Seto, K. F. Shortridge, and J. S. M. Peiris Evaluation of the Directigen FluA B test for rapid diagnosis of influenza virus type A and B infections. J. Clin. Microbiol. 40: Effler, P. V., M. Ieong, T. Tom, and M. Nakata Enhancing public health surveillance for influenza virus by incorporating newly available rapid diagnostic tests. Emerg. Infect. Dis. 8: Fong, C. K. Y., M. K. Lee, and B. P. Griffith Evaluation of R-Mix FreshCells in shell vials for detection of respiratory viruses. J. Clin. Microbiol. 38: Jensen, C., and F. B. Johnson Comparison of various transport media for viability maintenance of herpes simplex virus, respiratory syncytial virus, and adenovirus. Diagn. Microbiol. Infect. Dis. 19: McBean, A. M., J. D. Babish, and J. L. Warren The impact and cost of influenza in the elderly. Arch. Intern. Med. 153: Neuzil, K. M., Y. Zhu, M. R. Griffin, K. M. Edwards, J. M. Thompson, S. J. Tollefson, and P. F. Wright Burden of interpandemic influenza in children younger than 5 years: a 25-year prospective study. J. Infect. Dis. 185: Noyola, D. E., and G. J. Demmler Effect of rapid diagnosis on management of influenza A infections. Pediatr. Infect. Dis. J. 19: Pregliasco, F., S. Puzelli, C. Mensi, G. Anselmi, R. Marinello, M. L. Tanzi, C. Affinito, M. C. Zambon, and I. Donatelli Influenza virological surveillance in children: the use of the QuickVue rapid diagnostic test. J. Med. Virol. 73: Rodriguez, W. J., R. H. Schwartz, and M. M. Thorne Evaluation of diagnostic tests for influenza in a pediatric practice. Pediatr. Infect. Dis. J. 21: Steininger, C., M. Kundi, S. W. Aberle, J. H. Aberle, and T. Popow-Kraupp Effectiveness of reverse transcription-pcr, virus isolation, and enzyme-linked immunosorbent assay for diagnosis of influenza A virus infection in different age groups. J. Clin. Microbiol. 40: Wunderli, W., Y. Thomas, D. A. Muller, M. Dick, and L. Kaiser Rapid antigen testing for the surveillance of influenza epidemics. Clin. Microbiol. Infect. 9: Downloaded from cvi.asm.org at KOREA UNIV. on August 7, 2007

012임수진

012임수진 Received : 2012. 11. 27 Reviewed : 2012. 12. 10 Accepted : 2012. 12. 12 A Clinical Study on Effect of Electro-acupuncture Treatment for Low Back Pain and Radicular Pain in Patients Diagnosed with Lumbar