アジア準訳APG

全面：一次檢測可對比 27,000 多跨物種病原 (含細菌、真菌、病毒及寄生蟲)

精準：相較臨床常規檢測，台灣在地臨床試驗數據指出可提高重症患者 62 % 病原檢出率

快速：檢體送達實驗室，24-48 小時內可提供檢驗報告，即時輔助臨床醫師診斷及治療

Comprehensive： Able to Detect 27,000 types of Pathogens (Bacteria, Fungus, Viruses, Parasite) in under a Single Test

Precise： Compared to Conventional Microbiology Methods, able to increase in 62 % Positive Pathogen Detection Rate

Efficient： Provide Report within 24-48 hrs. to Assist Physicians in Time for Making Clinical Decisions

經臨床醫師診斷評估判定有檢查臨床需求之感染症病人，例如：敗病程進展急、病情嚴重、或常規病原檢驗診斷困難等族群。

Patients diagnosed by clinicians as having infections and in need of testing, such as those with rapidly progressing sepsis, severe illness, or cases where conventional pathogen diagnostics are challenging.

百微解 APGseq 感染病原基因定序檢測，可簡單分成 5 個步驟：
1. 萃取：提取感染症病人檢體內的所有核酸。
2. 建庫：利用 Shotgun 法(酵素)將所有取得的核酸片斷化，給予可辨識標籤。
3. 定序：藉由定序儀透過光學偵測將備好的片斷核酸進行定序，產出序列數據。
4. 分析：定序出序列數據，藉由生物資訊分析及比對病原資料庫，來鑑定哪些序列可能是感染致病原。
5. 報告：醫檢師會再次審核分析出的可能致病原，最後提交檢測報告給醫療機構報告簽屬醫師。

The APGseq consists of five steps:

1. Extraction: Extract all nucleic acids from the patient’s sample.
2. Library Preparation: Using the Shotgun method, fragmentize all obtained nucleic acids and assign identifiable tags.
3. Sequencing: Utilize a sequencer with optical detection to sequence the prepared nucleic acid fragments, generating sequencing data.
4. Analysis: Analyze the sequencing data using bioinformatics analysis and match it against pathogen databases to identify which sequences may correspond to infectious pathogens.
5. Reporting: Clinical laboratory technician will review the analysis of potential pathogens and generate a final report for review by the designated physician.

百微解 APGseq 感染病原基因定序檢測，可簡單分成 5 個步驟：
1. 與主治醫師 (臨床開單醫師) 充分討論，選定適合的檢查規格。
2. 主治醫師判定感染部位請相關單位採集對應檢體，如血液、肺泡灌洗液或組織等。
3. 檢查將委託院外認證實驗室 (精準醫療分子檢測實驗室列冊登錄編號 LDT0014 ) 代檢，檢體將送至亞洲準譯分子檢驗實驗室進行實驗 (地址：新北市汐止區新台五路一段 93 號 9F-12 )。
4. 檢查所需時間從檢體送達認證實驗室起算， 3 個工作天內，由實驗室提供實驗室版本檢測報告給醫療機構報告簽屬醫師進行審核。
5. 醫療機構報告簽屬醫師審核後，將發出院內版本檢測報告給主治醫師及相關委託單位。

1. Consult with the attending physician to determine the appropriate testing specifications.
2. The physician will identify the infection site, and relevant departments will collect the appropriate sample (e.g., blood, bronchoalveolar lavage fluid, or tissue).
3. The test will be outsourced to an accredited external laboratory (Laboratory Developed Tests and Services, license number LDT0014). Samples will be sent to the Asia Pathogenomics Medical Laboratory (Address: 9F-12, No. 93, Section 1, Xintai 5th Road, Xizhi District, New Taipei City) for analysis.
4. Turnaround time: Starting from the receipt of the sample at the accredited laboratory, a laboratory version of the test report will be provided to the institution within 3 working days for review by the designated physician.
5. After the physician’s review, an internal report version will be issued to the attending physician and relevant requesting departments.

(沒有任何醫療處置是零風險，以下所列風險已被認定，但仍有些醫師無法預期的風險未列出)
1. 本檢查檢測極限依每個病原微生物的種類而有所不同，約為 1~ 678 (cells/500 mL) 不等，低於該檢測極限的微生物不能保證可以檢出。檢測報告未檢出特定微生物，並不能排除患者感染某種病原微生物的可能性，如處於檢測範圍之外的微生物所造成的感染。
2. 抗感染藥物的使用，可使檢體中微生物含量有所降低，而影響檢體的檢出率。若在採檢前或中已進行抗感染藥物治療，需與主治醫師提前進行溝通，否則也有可能導致檢查不出致病微生物。
3. 鑒於檢測原理和當前技術的侷限，以及受檢者個體差異等，即使在醫院或認證實驗室以嚴格履行工作職責和操作規範的情況下，仍可能存在無法檢出、檢測失敗等情形。
4. 雖然核酸檢測技術準確率極高，但少數檢測錯誤仍可能發生。
5. 少數情況下(如：檢體量不足、凝血、溶血等)，採集錯誤檢體部位或檢體萃取的核酸量低於檢測建議範圍，等情況下，仍可能存在無法檢出等情形，建議重新進行採檢。
6. 此檢查的結果不應作為診斷、治療或其它醫療處置決定的唯一基礎。本項試驗檢測到的病原體，也有可能不是感染的確切原因。除了本項試驗外，也可能需要進行其他實驗室檢驗，綜合考量下最終由醫師執行後續臨床處置。

(No medical procedure is risk-free; known risks are listed below, while some unforeseen risks may not be included.)

1. The detection limit varies by pathogen type, approximately ranging from 1 to 678 cells per 500 mL. Microorganisms below this detection limit may not be identified.
2. A negative result in the report does not rule out the possibility of infection by a pathogen, especially if it is outside the test's detection range.
3. The use of antibiotics can reduce the microbial load in the sample, potentially affecting the detection rate. If the patient has already started anti-infective treatment before or during sample collection, it is essential to communicate this with the attending physician, as it may impact pathogen detection.
4. Due to the principles of the test, current technological limitations, and individual patient differences, there may still be cases where pathogens are not detected or the test may fail, even with strict adherence to procedures in hospitals or accredited laboratories.
5. Although nucleic acid testing is highly accurate, rare errors may still occur.
6. In some cases (e.g., insufficient sample volume, clotting, hemolysis, etc.), incorrect sample collection sites, or nucleic acid extraction yielding lower-than-recommended amounts, there may be detection issues, potentially requiring a repeat sample.
7. This test result should not be used as the sole basis for diagnosis, treatment, or other medical decisions. Pathogens detected by this test may not always be the actual cause of infection. Other tests may also be required for a comprehensive assessment, with final clinical decisions made by the attending physician.

因醫療法規保障就醫者安全，檢測單位責任義務僅限於產出報告， 檢驗報告須由主治醫師進行專業解讀及判斷，報告的說明、後續治療方針，僅能與醫師進行諮詢討論。

To protect patient safety under medical regulations, our laboratory responsibility is limited to generating the report. Only the attending physician can professionally interpret the report’s results. Any explanation of the report, as well as further treatment plans, please discuss with your attending physician.