醣時
中文品名：羅氏可霸斯生化快速監測系統 英文品名： cobas b 101 System 醫材字號：衛部醫器輸字第026530號 效能： 申請商名稱：台灣羅氏醫療診斷設備股份有限公司 申請商地址：台北市中山區民權東路3段2號10樓 製造廠名稱：PHC Corporation In Vitro Diagnostics Division Wakimachi Plant 製造廠廠址：110 Oaza-Inoshiri-aza-Nishiueno, Wakimachi, Mima, Tokushima, 779-3603, Japan
Roche cobas b 101 羅氏可霸斯糖化血色素及血脂快速監測系統
本系統是預定在臨床實驗室或定點照護(PoC)場所裡供專業人員使用使用前請務必詳閱原廠之使用說明書並遵照指示使用限醫療專業人士使用
cobas 糖化血紅素 A1c 測試組
衛部醫器輸壹字第013986號
 2 | 2μL 新鮮毛細血管全血或血清 （K2或K3-EDTA靜脈全血） |
 | 室溫下保存期限為22個月 |
 | 可使用指尖採血 |
 | 6分鐘得到檢測結果 |
 | 測量範圍：4‐14 % |
cobas 脂蛋白三合一分析試劑組
衛部醫器輸字第026530號
| 2 | 19μL 新鮮毛細血管全血或血清 （K2或K3-EDTA靜脈全血） |
| 室溫下保存期限為16個月 |
| 可使用指尖採血 |
| 6分鐘得到檢測結果 |
| 測量範圍 膽固醇：50-500 mg/dL 三酸甘油脂：45-650 mg/dL HDL膽固醇 15-100 mg/dL |
cobas C-反應蛋白檢測試劑
衛部醫器輸壹字第033490號
| 2 | 12μL 新鮮毛細血管全血或血清 （EDTA K2/K3 或鋰肝素抗凝全血或血漿） |
| 室溫下保存期限為16個月 |
| 可使用指尖採血 |
| 4分鐘得到檢測結果 |
| 測量範圍：0.3~40 mg/dL |
更多內容
cobas b 101 system
One-stop solution for HbA1c, lipids, and CRP testing in the Primary Care Setting
The cobas b 101 system is an IVD test system offering HbA1c, lipid panel and CRP tests at the Point of Care. Fresh capillary blood, K2 or K3-EDTA or lithium heparin anticoagulated venous whole blood can be used for HbA1c. Fresh capillary blood, K2 or K3-EDTA anticoagulated whole blood or plasma can be used for lipids (CHOL, TRIGL, HDL-CHOL, LDL, non-HDL). Fresh capillary blood or serum, K2 or K3-EDTA or lithium heparin anticoagulated whole blood or plasma can be used for CRP. The system delivers fast and reliable results and is intended for professional use in a clinical laboratory or at Point of Care locations.
Guideline compliant performance
- cobas b 101 system complies with all relevant standards and methods (IFCC, DCCT/NGSP)1
Easy and safe operation
- Direct blood application from a single finger stick with small volume
- No calibration needed, maintenance and service-free, guidance by the graphical user interface (GUI)
Fast turnaround time
- From patient preparation to displaying dual testing results in a less than 15-minute workflow and single testing results in about 6 minutes (CRP in less than 4 minutes)
- A choice of single HbA1c, lipid panel and CRP testing or dual HbA1c and lipid panel tests
System characteristics
- User-friendly with a large touchscreen, full keyboard, and multiple language support
- Robust, maintenance- and calibration-free with a wide operating temperature and humidity range
- Connection to cobas® infinity POC IT solutions
- External printer or barcode scanner allow an improved workflow and documentation
- Data download to USB stick and then to a PC or data download to IT solutions installed on PC.
Disc Features
- Direct sample application from finger (no capillaries, tubes or pipettes are needed)
- Requires only very small sample volumes (2 μL for HbA1c, 19 μL for lipids and 12 μL for CRP)
- Discs are color-coded and clearly labelled to support correct use.
- Hinge cover concept for operator safety
- Discs can be stored for more than 16 months at room temperature (2-30 ºC)2,3,4
Overview
- The cobas b 101 is an in vitro diagnostic instrument for the quantitative evaluation of clinical chemistry assays and immunoassays using the cobas b 101 test discs. The cobas b 101 instrument is intended for near-patient testing. Not for self-testing.
Regulatory Disclaimer
- For in vitro diagnostic use.
Product specifications
Sample size
- HbA1c: 2 μL
- Lipid: 19 μL
- CRP: 12 μL
Sample material
- HbA1c: Capillary whole blood, venous whole blood with anticoagulant (EDTA or heparin)
- HbA1c PST: Capillary whole blood
- Lipids: Capillary whole blood, venous whole blood or plasma with anticoagulant (EDTA)
- Lipid PST: Capillary whole blood
- CRP: Capillary whole blood or serum, venous whole blood or plasma with anticoagulant (EDTA or heparin)
Measurement range
- HbA1c: 20-130 mmol/mol (IFCC) or 4-14 % (DCCT/NGSP)
- Lipid: CHOL: 50-500 mg/dL or 1.28-12.95 mmol/L
- TRIGL: 45-650 mg/dL or 0.50-7.35 mmol/L
- HDL-CHOL: 15-100 mg/dL or 0.38-2.60 mmol/L
- LDL-CHOL: estimated using the Friedewald equation
- CRP: 3.0-400 mg/L or 0.30-40.0 mg/dL
Test storage
- 2-30 °C
Test stability
- Unopened: CRP Lipid: 16 months
- HbA1c: 22 months
- Opened: 20 minutes
