Đánh giá kết quả thử nghiệm chương trình ngoại kiểm huyết thanh học viêm gan siêu vi B và C

0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Thị Lệ Xuân Bùi, Hùng Linh Đặng, Thị Xuyến Đậu, Thị Diễm Phúc Huỳnh, Phú Cường Lê, Văn Chương Lê, Quốc Đạt Ngô, Thị Tú Anh Nguyễn, Tiến Huỳnh Nguyễn, Nhật Nguyên Trần

Ngôn ngữ: vie

Ký hiệu phân loại: 571.74 Biochemistry of control

Thông tin xuất bản: Y học cộng đồng, 2023

Mô tả vật lý: 285-292

Bộ sưu tập: Metadata

ID: 502406

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Chủ đề

Đánh giá kết quả thử nghiệm chương trình ngoại kiểm huyết thanh học viêm gan siêu vi B và C trên các bộ mẫu đông khô chứa 06 thông số HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc total và Anti-HCV. Đối tượng và phương pháp nghiên cứu: Nghiên cứu mô tả cắt ngang nhằm đánh giá kết quả thử nghiệm chương trình với 03 bộ mẫu gồm: Lô 1 (dương tính với Anti-HBs và Anti-HCV)
Lô 2 (dương tính với HBsAg, Anti-HBc total và Anti-HBe)
Lô 3 (dương tính với HBsAg, Anti-HBc total và HBeAg) bằng các phương pháp xét nghiệm nhanh và Miễn dịch điện hóa phát quang/miễn dịch hóa phát quang (ECLIA/CLIA) được thực hiện tại 35 phòng xét nghiệm trên phạm vi cả nước. Kết quả: Phương pháp xét nghiệm nhanh chiếm tỉ lệ 35,14%, phương pháp ECLIA/CLIA có nhóm thiết bị Roche Cobas e601 chiếm tỉ lệ 18,92%, Abbott (16,22%), các nhóm thiết bị Roche Cobas e411, Roche Cobas e801, Siemens Atellica IM, Beckman DxI 600/800 lần lượt là 13,51%, 5,41%, 5,41%, 5,41%. Khi phân tích định tính cả phương pháp xét nghiệm nhanh và phương pháp ECLIA/CLIA đều cho kết quả 100% đồng thuận. Kết luận: Kết quả thử nghiệm chương trình ngoại kiểm huyết thanh học viêm gan siêu vi B và C trên các bộ mẫu đông khô phù hợp với tất cả các phương pháp xét nghiệm và các dòng máy hiện có tại các đơn vị tham gia. Đây là cơ sở khoa học để ứng dụng triển khai chương trình ngoại kiểm huyết thanh học viêm gan siêu vi B và C ở dạng mẫu đông khô.To evaluate results of the trial External Quality Control (EQA) for hepatitis B and C program using lyophilized method, which is included 06 parameters HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc total and Anti-HCV. Subject and method: A cross-sectional descriptive research was conducted to assess the program's testing outcomes using 03 sample sets, including: Lot 1: Anti-HBs (+), Anti-HCV (+)
Lot 2: HBsAg (+), Anti-HBc total (+), Anti-HBe (+)
Lot 3: HBsAg (+), Anti-HBc total (+), HBeAg (+) using both rapid testing and ECLIA/CLIA methods. Results: The rapid testing method accounted for 35.14% of the overall utilization, ECLIA/CLIA with Roche Cobas e601 equipment represented 18.92%, Abbott accounted for 16.22%, while the groups with Roche Cobas e411, Roche Cobas e801, Siemens Atellica IM, Beckman DxI 600/800 made up 13.51%, 5.41%, 5.41%, and 5.41%, respectively. Qualitative analysis revealed 100% agreement between the rapid testing and ECLIA/CLIA methods. Conclusion: The serological testing of hepatitis B and C in lyophilized sample is suitable for all testing methods and instrument platforms used in participating laboratories. This research can be applied to implement the EQA program for hepatitis B and C as lyophilized serum sample.

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