Supplementary Infection & Chemotherapy 중동호흡기증후군코로나바이러스검사실진단지침 대한진단검사의학회 메르스에대한기본설명 1. 한글명 2. 영문명 Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) RNA 환자정의 (case definition) 1. 확진환자 (confirmed case) [1-4] 1) 정의 (MERS-CoV) ( ) 2) 검사방법 1 Reverse transcriptase Real-time PCR (rrt-pcr): MERS-CoV 2 : MERS-CoV (2 4 ) 2. 의심환자 (suspected case) 1) 정의 : 아래의 a)-b) 에해당하는자 a. ( ) 1 14 2 14 ( ) b. (, ) 1 14 ( ),, 2 ( ) 3 14 (2 ),, 2) 중동지역 a. : b. :,,,,,,,,,,,, 3. 밀접접촉자 1) : 2 a. (,, N95, ) b. 1 2 2 / /(, ) 3 2), Received: October 13, 2015 2015 년 6 월 8 일중앙메르스관리대책본부공식지침으로대한감염학회홈페이지에게재되었음.
대한진단검사의학회 중동호흡기증후군코로나바이러스검사실진단지침 검사의적응증,. 1. 메르스감염확진환자의격리해제 1). 2). a. 48: (,, ),, X b. 24 PCR 2 :, Tracheal aspirate.. [5]. 7 14 ( 2),. 4. 원인을알수없는호흡기감염의원인감별,. * parainfluenza, rhinovirus, influenza A (H1N1)pdm09, herpes simplex, influenza B,. 2. 메르스감염의심환자의확진 1) 기관삽관된환자 (tracheal aspirate). 2) 기관삽관되지않은환자 *.. 3. 밀접접촉자의선별, 검체의종류와채취 1. 검체의종류 1) 2) :, (bronchoalveolar lavage, BAL), ( 1) *. 3) : /,, ( 1) * / flocked swab, UTM ( ). 표 1. MERS-CoV 분자진단을위한검체 검체종류수송배지검사실수송 하기도검체 객담 기관지폐포세척액 Tracheal aspirate 생검또는부검폐조직바이러스수송배지또는무균식염수 ( 세균배양 ) 상기도검체 비인두흡인액 비인두 / 구인두도찰 UTM 배지 MERS-CoV, Middle East Respiratory Syndrome Coronavirus. a 진단을위한검체는증상발현 7 일이내에채취하는것이좋다. 4 C a 검사가 72 시간이상지연되면냉동또는드라이아이스와함께수송 검체수송감염성검체분류 카테고리 B
중동호흡기증후군코로나바이러스검사실진단지침 대한진단검사의학회 표 2. 혈청학적진단을위한검체 환자분류급성기혈청회복기혈청 확진또는의심환자 병원내원당일채혈 ( 증상발현 7일이내 ) 급성기검체채혈일부터 14일이후채혈, 두번째 회복기검체는 7일간격채혈 확진또는의심환자 (7 일이내미채혈 ) 없음증상발현 14 일이지난후채혈 밀접접촉자 최종노출일기준으로 14일이내채혈 급성기검체채혈일부터 14일이후채혈, 두번째 회복기검체는 7일간격채혈 밀접접촉자 (14 일이내미채혈 ) 없음최종노출일기준으로 14 일이지난후채혈 4) 1 : ( ) 3-4 1 (5-10 ml), 1 ml. ( 2),. (4 C*) 72,. * 2 EDTA : buffy coat. 2. 검체채취주의사항 1),, 2) (N95,,, ) 1. :,,,, 2. 1) 2) : N95,,, 3) ㆍ, 3. 1) 1 6-12 ( duct ) 2) ( 12 30) 3) 표 3. MERS-CoV 확인진단법및표적유전자진단법표적유전자확인진단법실시간역전사중합효소연쇄반응 upe, ORF1a, ORF1b, N 역전사중합효소연쇄반응-염기순서분석 ORF1b (RdRp), N MERS-CoV, Middle East Respiratory Syndrome Coronavirus. 검체포장및운송 1. 의료기관내검체포장및운송 1) 1. 2) 1( ) 70% 2 2. 외부운송 1) 1( ) 70% 2) 2, 2 3) ( ) 3 (3) 진단기준 : 1) MERS-CoV (upe, ORF1a, ORF1b, N) 2 real-time RT-PCR ( ) 2) MERS-CoV (ORF1b [RdRp], N) 1 RT- PCR PCR ( 3) * : 14 (sero-conversion) ( ELISA IFA )
대한진단검사의학회 중동호흡기증후군코로나바이러스검사실진단지침 검체처리및검사방법 1. level D, class II - BSC. BSC N95 2. 3. - - WHO 4. 70% 5. 결과판독및보고 1. 결과판독가이드라인 1) 선별검사 (upe) a. Internal control(-):. b. IC(+), (-): (Negative),, c. IC(+), (+), Ct>Cutoff: (Indeterminate), d. IC(+), (+), Ct Cutoff: (Screen positive), 2) 해결방안 a. b. internal control c., / 결과보고서 1. 검체의기본정보,,,,,,,,,, 2. 결과보고 1) (Negative): 2) (Indeterminate): 3) (Equivocal): 4) (Positive in confirmation) : 5) (Positive): 2) 확인검사 (ORF1a, ORF1b 등 upe 외타겟유전자 ) a. (-): [Indeterminate], b. (+), Ct > Cutoff: (Equivocal), c. (+), Ct Cutoff: (Positive in confirmation), / d. : (Positive) 3. 검체의질등에대한비고사항 4. 결과보고시간 검사실생물안전및감염관리지침 2. 접촉력이분명한의심환자에서지속적으로음성결과가나오더라도메르스감염을배제할수는없으며, 위음성을감별하기위해다음을참고한다. 1) 위음성의원인 a. b. c. d. : (middle east respiratory syndrome coronavirus, MERS-CoV),,. MERS- CoV,. MERS-CoV.
중동호흡기증후군코로나바이러스검사실진단지침 대한진단검사의학회 1. 검체채취및취급시감염관리. 2. 검체관리 1) ( ) : MERS-CoV 2) a b. MERS-CoV 3. MERS-CoV 의심되는환자로부터혈액이외의체액및호흡기검체채취, 운송, 보관 3 1) 1 * : 70% 1% sodium hypochlorite 2) 1( ) 2 3) 2 3 4) ( ) 3 5) 3,, 6) 3 ( ) 4 7), UN 2814,,,, 1) (, ), 2) ( ) (2), (MERS-CoV ),, -, 3) / a. 4 C b. 72-70 C 4) (EDTA blood): 5) ( ) a. : b. : 70% 2 c. 2 (PP ). autoclave.. d. 2 ( ). e.,. f. : 3 6) a. [6] 1 Level D :, ( ).., N95. 2 ClassⅡ : (,, ), 3 - ) BSC b. BSC c. 70%. d., autoclave. 7) (, ) a.,,. b. (, BAL), (cytospin ) BSC
대한진단검사의학회 중동호흡기증후군코로나바이러스검사실진단지침 c., () Class Ⅱ. d. BSL-2 BSL-2 1 2 3 Glutaraldehyde 4 5 3 ( ) : 2 6 ( ) e. Class II BSC 1 2 3 4 5 BSC * BSC, ) - ( ), ( ), (to-deliver to-contain ), ( BSC ), ( ), (, ), (BSC ) * BSC : fumigation. f. MERS-CoV BL3 8) a.,, pipette tip Y bag autoclave,, b. Y-bag. c. : 1 121 C 15 d.,, ( ) 1 : 70% 0.5% ( [5%] 10 ) 2 3, 9), 3-1 (2015. 5. 26). ), References 1. Korea Centers for Disease Control and Prevention (KCDC). Guidelins for MERS-CoV control. 3-3ed. Osong: KCDC; 2015. 2. World Health Organization (WHO). Laboratory testing for Middle East Respiratory Syndrome Coronavirus: Interim recommendations (revised). Available at: http://www. who.int/csr/disease/coronavirus_infections/who_interim_recommendations_lab_detection_merscov_092014. pdf. Acessed 12 October 2015. 3. Centers for Disease Control and Prevention (CDC). Interim guidelines for collecting, handling, and testing clinical specimens from patients under investigation (PUIs) for Middle East Respiratory Syndrome Coronavirus (MERS- CoV) Version 2.1. Available at: http://www.cdc.gov/coronavirus/mers/downloads/guidelines-clinical-specimens. pdf. Accessed 12 October 2015. 4. European Centre for Disease Prevention and Control (ECDC). Factsheet for health professionals. Available at: http://ecdc.europa.eu/en/healthtopics/coronavirus-infections/mers-factsheet/pages/default.aspx. Accessed 12 October 2015. 5. Drosten C, Meyer B, Müller MA, Corman VM, Al-Masri M, Hossain R, Madani H, Sieberg A, Bosch BJ, Lattwein E, Alhakeem RF, Assiri AM, Hajomar W, Albarrak AM, Al-Tawfiq JA, Zumla AI, Memish ZA. Transmission of MERS-coronavirus in household contacts. N Engl J Med 2014;371:828-35. 6. World Health Organization (WHO). Laboratory biosafety manual: Third edition. Available at: http://www.who.int/ csr/resources/publications/biosafety/biosafety7.pdf?ua=1. Accessed 12 October 2015.