Mycoplasma pneumoniae 감염의 신속 항원 검사 키트 “Ribotest Mycoplasma®”의 진단적 평가
Evaluation of a Rapid Diagnostic Antigen Test Kit Ribotest Mycoplasma® for the Detection of Mycoplasma pneumoniae
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목적: Mycoplasma pneumoniae 폐렴은 학동기 소아와 청소년의 지역사회 획득 폐렴 중 가장 흔한 원인으로, 조기에 원인 진단이 가능하다면 적절한 항균 요법을 결정하는데 도움이 된다. 본 연구는 하기도 감염 소아의 호흡기 검체에서 M. pneumoniae 를 검출하기 위한 신속 항원 검사 방법의 진단적 가치를 평가하고자 하였다. 방법: 2010년 8월부터 2018년 8월까지 하기도 감염으로 서울대학교 어린이병원에서 응급실 또는 입원 치료를 받은 소아로부 터 채취한 비인두 흡인물 중 M. pneumoniae 배양 검사를 시행한 후 −70°C 초저온냉동고에 보관되어 있는 검체 215개를 선정하 였다. 비인두 흡인물 검체를 실온에서 해동하고 면역크로마토그래피를 이용한 Ribotest Mycoplasma®를 시행한 후 두 명의 검사자가 결과를 판독하였다. 검사를 시행하는 자와 판독하는 자는 배양 검사 결과를 모르는 상태에서 검사를 진행하였다. 결과: 총 215개의 비인두 흡인물 검체 중 M. pneumoniae 가 배양 양성인 검체는 119개, 배양 음성인 검체는 96개였다. M. pneumoniae 가 배양 양성인 119개 중 74개(62.2%)가 Ribotest Mycoplasma® 검사 결과 양성이었고, 배양 음성인 96개 중 92개(95.8%) 가 Ribotest Mycoplasma® 검사 결과 음성이었다. 배양 검사 결과를 기준으로 평가한 Ribotest Mycoplasma®의 민감도는 62.2% (74/119, 95% 신뢰구간, 53.5–70.9%)이었으며, 특이도는 95.8% (92/96, 95% 신뢰구간, 91.8–99.8%)이었다. 또, 양성 예측도는 94.9% (74/78, 95% 신뢰구간, 90.0–99.8%)이었으며, 음성 예측도는 67.2% (92/137, 95% 신뢰구간, 59.3–75.0%), 그리고 일치도 77.21% (166/215, 95% 신뢰구간, 71.6–82.8%)를 보였다. 결론: 본 연구 결과, 신속 항원 검출법인 Ribotest Mycoplasma® 검사결과가 양성인 경우는 M. pneumoniae 배양 양성과의 일치 도가 매우 높아서 M. pneumoniae 감염의 진단에 유용하였다. 그러나, Ribotest Mycoplasma® 검사결과가 음성인 경우의 약 1/3 은 M. pneumoniae 배양 양성인 검체이었으므로, 음성 검사 결과에 대한 해석은 주의하여야 한다.
Abstract
Purpose: Early detection of Mycoplasma pneumoniae is important for appropriate antimicrobial therapy in children with pneumonia. This study aimed to evaluate the diagnostic value of a rapid antigen test kit in detecting M. pneumoniae from respiratory specimens in children with lower respiratory tract infection (LRTI). Methods: A total of 215 nasopharyngeal aspirates (NPAs) were selected from a pool of NPAs that had been obtained from children admitted for LRTI from August 2010 to August 2018. The specimens had been tested for M. pneumoniae by culture and stored at −70°C until use. Tests with Ribotest Mycoplasma® were performed and interpreted independently by two investigators who were blinded to the culture results. Results: Among the 215 NPAs, 119 were culture positive for M. pneumoniae and 96 were culture negative. Of the culture-positive specimens, 74 (62.2%) were positive for M. pneumoniae by Ribotest Mycoplasma®, and 92 of the 96 (95.8%) culture-negative specimens were negative for M. pneumoniae by Ribotest Mycoplasma®. When culture was used as the standard test, the sensitivity and specificity of Ribotest Mycoplasma® were 62.2% and 95.8%, respectively. Additionally, the positive predictive value, negative predictive value, and overall agreement rates with Ribotest Mycoplasma® were 94.9%, 67.2%, and 77.2%, respectively. Conclusions: A positive test result of Ribotest Mycoplasma® suggests a high likelihood of culturepositive M. pneumoniae infection. However, a negative test result should be interpreted with caution because nearly one-third of negative test results reveal culture-positive M. pneumoniae infections.
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