半線防疫網

2009年，美國新型流感H1N1快篩試劑評估

Evaluation of Rapid Influenza Diagnostic Tests for Detection of Novel Influenza A (H1N1) Virus --- United States, 2009 

美國疾管局發行的發病率和死亡率週報2009年8月7日/ 58 （ 30 ） ; 826-829；

MMWR  August 7, 2009 / 58(30);826-829

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5830a2.htm

最近出現全球擴散的新型流感H1N1病毒大流行，強調需要評估這些廣泛使用的商用快速流感診斷試劑（ RIDTs ），用在檢測臨床呼吸道檢體的病毒抗原準確能力。 The recent appearance and worldwide spread of novel influenza A (H1N1) virus (1,2) has highlighted the need to evaluate commercially available, widely used, rapid influenza diagnostic tests (RIDTs) for their ability to detect these viral antigens in respiratory clinical specimens.

以在2009年4月--5月期間採集65件臨床的呼吸道的檢體，這些檢體在以前已用即時反轉錄--多聚酵素連鎖反應 ( rRT-PCR )檢驗方法確診陽性反應的的檢體，其中有新型流感( H1N1 )病毒或季節流感( H1N1 )病毒或( H3N2 )病毒陽性反應的檢體，美國疾管局用這些確診陽性反應的檢體來作多重分析這些商用快速流感診斷試劑準確性的最初評估。As an initial assessment, CDC conducted an evaluation of multiple RIDTs. Sixty-five clinical respiratory specimens collected during April--May 2009* that had previously tested positive either for novel influenza A (H1N1) or for seasonal influenza A (H1N1) or A (H3N2) viruses by real-time reverse transcription--polymerase chain reaction (rRT-PCR) assay were used in the evaluation.

分析檢測結果顯示，雖然這些商用快速流感診斷試劑能夠從包含高濃度病毒的 (以低循環閾值[Ct]表示 )臨床的呼吸道的檢體中，檢測出新型流感( H1N1 )病毒, 但分析以這些商用快速流感診斷試劑做檢測全部陽性反應檢體包括其中病毒濃度減少的檢體(增高循環閾值[Ct])的敏感度是偏低的，介於40%--69%中間，全部樣品測試. The results showed that, although the RIDTs were capable of detecting novel A (H1N1) virus from respiratory specimens containing high levels of virus (as indicated by low cycle threshold [Ct] values), the overall sensitivity was low (40%--69%) among all specimens tested and declined substantially as virus levels decreased (and Ct values increased).

這些發現物指出，雖然肯定這些商用快速流感診斷陽性反應結果能用來做為治療的決定，但不能以流感快篩陰性反應結果，做為排除新型流感( H1N1 )病毒感染。These findings indicate that, although a positive RIDT result can be used in making treatment decisions, a negative result does not rule out infection with novel influenza A (H1N1) virus.

從新型流感( H1N1 )病毒 或季節流感( H1N1 ) 病毒或( H3N2 ) 病毒確診的病人採取臨床的呼吸道的檢體 (鼻咽拭子和口咽拭子)，做為主要提供（美國）州衛生實驗室的研究用途。.Original clinical materials (e.g., specimens from nasopharyngeal swabs and oropharyngeal swabs) collected from patients with confirmed novel influenza A (H1N1) or seasonal influenza A (H1N1) or (H3N2) virus infection and provided largely by state health laboratories were used in the study.

以美國疾管局研發並經美國食品及藥物管理局認証的即時反轉錄--多聚酵素連鎖反應 ( rRT-PCR )檢驗方法，來做確診新型流感或季節流感A型病毒。以美國疾管局研發的即時反轉錄--多聚酵素連鎖反應( rRT-PCR )檢驗方法的敏感度 (99.3%) 和特異性 (92.3%) 做為和季節流感病毒培養做比對檢測。

The presence of novel or seasonal influenza A virus was confirmed by rRT-PCR assay developed by CDC and approved as a Section 501(k) device by the Food and Drug Administration. Detailed data regarding sensitivity (99.3%) and specificity (92.3%) for the seasonal influenza A CDC rRT-PCR assay compared with viral culture are available.†

新型流感( H1N1 )病毒或季節流感( H1N1 )病毒或( H3N2 )病毒確診的病人採取臨床的呼吸道的檢體是被用來做比對檢測3家美國流感快篩試劑供應商：Inverness Medical BinaxNOW Influenza A&B (Binax, Inc., 斯卡洛堡,緬因州); Becton Dickinson Directigen EZ流感A+B (Becton,Dickinson和公司,斯派克斯,馬里蘭州);和Quidel QuickVue流感A+B (Quidel公司,聖地牙哥,加州)..The original clinical specimens were tested using RIDTs from three companies: Inverness Medical BinaxNOW Influenza A&B (Binax, Inc., Scarborough, Maine); Becton Dickinson Directigen EZ Flu A+B (Becton, Dickinson and Company, Sparks, Maryland); and Quidel QuickVue Influenza A+B (Quidel Corporation, San Diego, California). 從4家其他的美國流感快篩試劑供應商只用一些有限的流感確診檢體做比對檢測；這些比對檢測結果未發表在這報告。RIDTs from four other companies were tested with limited numbers of specimens; those results are not presented in this report.。