THÔNG TIN CHUNG:
Test nhanh cúm A&B Genesis là một dụng cụ chuyên dùng trong phòng xét nghiệm để phát hiện kháng nguyên cúm A/B (nucleprotein) thu từ mẫu bệnh phẩm là dịch tiết ở mũi (qua đường hô hấp). Kit thử được thiết kế để phát hiện chủng loại nucleprotein A và B, phụ thuộc vào bề mặt proteins H và N (bao gồm H1N1 và H3N2). Chỉ chuyên dùng trong chẩn đoán xét nghiệm.
BẢO QUẢN KIT THỬ
Test nhanh cúm A&B Genesis nên được bảo quản ở nhiệt độ phòng trong bao bì hàn kín. Hạn sử dụng của kit thử được qui định theo điều kiện của phòng thí nghiệm thông thường.
Tiêu chuẩn sản phẩm Test nhanh cúm A&B Genesis:
Tác dụng | Phát hiện kháng nguyên Cúm loại A và loại B (H1N1 & H3N2) từ dịch tiết ở mũi |
Quy cách đóng gói | – 20 khay thử – 20 dung môi – 20 ống nghiệm – 20 que bông tiệt trùng – 01 hướng dẫn sử dụng |
Mẫu thử | Dịch tiết ở mũi (Nasal Swab) |
Thời gian đọc kết quả | 5-10 phút |
Hạn sử dụng | 24 tháng kể từ ngày sản xuất |
Điều kiện bảo quản | 2-30 độ C. |
THU MẪU BỆNH PHẨM
- Đưa que bông tiệt trùng vào sâu trong lỗ mũi, nơi có nhiều dịch tiết nhất.
- Xoay và đẩy thật nhẹ nhàng tăm bông cho tới vị trí lấy dịch tiết của mũi.
- Xoay nhẹ nhiều lần que tiệt trùng ở vị trí vách mũi.
CHUẨN BỊ MẪU BỆNH PHẨM
- Đặt que thu mẫu bệnh phẩm vào trong ống và khuấy để hoà trộn với thuốc thử trong ít nhất 1 phút.
- Sau đó thu lấy mẫu bệnh phẩm từ que bông càng nhiều càng tốt bằng cách ép và xoay que vào thành ống. Vứt bỏ que thu bệnh phẩm vào thùng rác. Khuấy đều hỗn hợp chất lỏng trong ống nghiệm. Hỗn hợp đã sẵn sàng để xét nghiệm.
QUY TRÌNH XÉT NGHIỆM
- Xé túi nhôm và lấy kit thử ra để nơi mặt phẳng khô, sạch.
- Đặt ống nhỏ giọt ở phía trên kit thử, nhỏ 4 giọt từ mẫu bệnh phẩm ở trên vào ô Sample Well (S) : chờ cho tới khi mỗi giọt được hấp thu, trước khi thêm giọt kế tiếp. Lưu ý : Nếu mỗi giọt chứa nhiều bọt khí, do khối lượng mẫu bệnh phẩm thực tế có thể đã ít hơn khối lượng tối thiểu yêu cầu.
- Khi kit thử bắt đầu hoạt động, bạn sẽ thấy màu tím xuất hiện ngang qua cửa sổ kết quả (result window) nằm ngay trung tâm kit thử.
- Chỉ đọc kết quả xét nghiệm trong 10 phút. Không đọc kết quả sau 15 phút.
Lưu ý: Thời gian đọc kết quả được thực hiện ở nhiệt độ phòng từ 15-30 o C .Nếu nhiệt độ phòng thấp hơn 15 oC, thì thời gian đọc kết quả cần phải được gia tăng một cách hợp lý.
CÁCH ĐỌC KẾT QUẢ:
- Một vạch màu sẽ hiển thị tại Vùng Bên Trái của cửa sổ kết quả cho thấy rằng kit thử hoạt động đúng. Vạch này là vạch chứng “C”(control band).
- Vùng Bên Phải của cửa sổ kết quả sẽ hiển thị kết quả xét nghiệm. Nếu vạch màu khác hiển thị tại Vùng Bên Phải, vạch này là vạch kết quả “T” (test band).
KẾT QUẢ DƯƠNG TÍNH: HAI VẠCH MÀU:
Sự hiện diện của hai vạch màu (vạch “T” and vạch “C” ) trong cửa sổ kết quả bất kể vạch màu nào hiển thị đầu tiên, đặc trưng cho kết quả Dương tính của cả Inf-A/Influ-B, tương ứng với kết quả
Hình 2: Kết quả dương tính với cả cúm A và B.
Hình 3: Kết quả dương tính chỉ với cúm B.
Hình 4: Kết quả dương tính chỉ với cúm A.
Lưu ý : Thông thường, với mức độ phân tích trong mẫu bệnh phẩm cao hơn, vạch màu “T” sẽ hiển thị rõ hơn. Khi mức độ phân tích của mẫu bệnh phẩm gần với giới hạn của độ nhạy, vạch màu “T” sẽ hiển thị mờ nhạt.
KẾT QUẢ ÂM TÍNH: MỘT VẠCH MÀU:
Sự hiện diện của một vạch màu trong cửa sổ kết quả đặc trưng cho kết quả Âm tính.
KẾT QUẢ KHÔNG HỢP LỆ:
Nếu trong quá trình xét nghiệm, không có vạch C và T nào hiển thị trong Cửa sổ kết quả, kết quả được xem như không hợp lệ. (Hình 6 và 7). Nguyên nhân gây ra kết quả không hợp lệ là: không theo dõi hướng dẫn sử dụng hoặc kit thử có thể đã hết hạn sử dụng. Khuyến cáo nên thực hiện mẫu bệnh phẩm với 1 bộ kit thử mới.
ĐỘ NHẠY VÀ ĐỘ ĐẶC HIỆU Test nhanh cúm A&B Genesis:
Kit thử được so sánh với RT-PCR về độ nhạy tương quan và độ đặc hiệu tương quan: RT- PCR tương quan về Độ nhạy/Độ đặc hiệu của Kit thử cúm A/B là
Độ nhạy : 84,4% (chủng A), 84,3% (chủng B)
Độ đặc hiệu: 94,7% (chủng A), 95,5% (chủng B)
Hệ thống cơ sở
Hà Nội: C13 Lô 18 – Khu Đô thị Định Công – Q.Hoàng Mai – TP. Hà Nội
HCM: Số 305 Khuông Việt – P. Phú Trung – Q. Tân Phú – TP.HCM
Huế: Số 140 Phan Bội Châu – P.Trường An – TP.Huế
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