Tri-Level Hematology Analyzer Control muaj stabilized human and mammalian cellular components suspended in a buffered fluid matrix. Formulated nyob rau hauv peb qhov sib txawv theem concentration-Low, Ib txwm, thiab siab- cov ntaub ntawv siv kua no txheeb xyuas qhov ntsuas qhov tseeb, taug qab kev ntsuas kev ruaj ntseg, thiab tus chij kev ua haujlwm tsis raug nyob thoob plaws hauv lub tshuab ntsuas ntshav.
Hematology Controls / Calibrators yog dab tsi?
Kev tswj kom zoo hauv kev kho mob hematology vam khom ntawm ob yam khoom siv sib txawv:
Tswj:Cov qauv ntsuas niaj hnub nrog cov txiaj ntsig paub qhov tseem ceeb thiab qhov txwv ntau. Lawv saib xyuas cov txheej txheem sab hauv precision thiab kev ua haujlwm zoo ib yam nyob rau lub sijhawm yam tsis tau hloov kho qhov ntsuas qhov system.
Calibrators:Dedicated reference standard muab tej yam tseem ceeb tseem ceeb. Lawv kho qhov ntsuas lub cev thiab hloov pauv coefficients kom ntseeg tau tias cov khoom siv tau raug tawm tsam cov txheej txheem siv.
Lub luag haujlwm hauv Hematology Quality Control
Kev ua haujlwm niaj hnub ntawm peb -theem tswj matrix suav nrog kev ua haujlwm tseem ceeb:
Analytical Decision Boundaries:Ntsuas qhov kev ua tau zoo ntawm cov kab mob pathological heev-xws li mob hnyav cytopenia thiab cim leukocytosis- nrog rau qib kev kho mob ib txwm muaj.
Kev kuaj pom yuam kev:Txheeb xyuas cov fluidic micro- blockages, reagent oxidation, optical laser degradation, thiab cov suab nrov hauv hluav taws xob ua ntej kev soj ntsuam.
Kev Ua Raws Cai:Ua tiav cov txheej txheem kev pov hwm zoo sab hauv uas yuav tsum tau muaj kev saib xyuas ntau dua - theem thoob plaws txhua qhov kev ua haujlwm.
Tswj Qib / Daim Ntawv Thov
Qib 1 (Low)
Lub hom phiaj ntawm txo cov cell concentrations. Kev ntsuas ntsuas cov lus teb ze rau qhov ntsuas qis qis rau cov qauv leukopenia, anemia, thiab thrombocytopenia kuaj.
Qib 2 (Nco)
Hom phiaj ntawm physiological ntau yam. Saib xyuas cov qauv kev ua haujlwm ntawm kev ua haujlwm zoo thaum lub sijhawm ua haujlwm txhua hnub.
Qib 3 (High)
Targeted nyob rau hauv elevated cell suav. Validates linearity thiab optical teb thaum lub sij hawm siab -tso tawm cov xwm txheej xws li leukocytosis lossis thrombocytosis.
Tswj vs. Calibrator
|
Yam ntxwv |
Hematology Tswj |
Hematology Calibrator |
|
Lub hom phiaj |
Saib xyuas txhua hnub system precision thiab stability |
Kho qhov ntsuas qhov tseeb qhov ntsuas |
|
Ntau zaus |
Txheeb xyuas txhua hnub lossis ib qho kev hloov pauv ua haujlwm |
Ua tiav tom qab calibration txij nkawm lossis hloov drift |
|
Cov ntaub ntawv hom |
Lub hom phiaj txhais tau tias ua ke nrog rau sab sauv / qis |
Tib lub hom phiaj tus nqi |
|
Action on Output |
Chij cov kev hloov pauv uas tsis tau xav txog |
Re- xam thiab sau cov txheej txheem nce qib |
Tau tshaj Hematology Analyzers
Formulated rau lub cev sib raug zoo thoob plaws cell suav platforms siv:
- Kev ntsuas hluav taws xob impedance
- Optical Laser Scattering
- Kev txiav txim siab hemoglobin Photometric
Muab Cov Nqis / Parameters
|
Parameter |
Chav tsev |
Tsawg (theem 1) |
Ib txwm (theem 2) |
Siab (Qib 3) |
|
WBC |
10⁹/L |
2.10 ± 0.40 |
7.20 ± 1.00 |
18.50 ± 2.50 |
|
RBC |
10¹²/L |
2.30 ± 0.20 |
4.40 ± 0.30 |
5.30 ± 0.40 |
|
HGB |
g/dL |
6.2 ± 0.5 |
13.5 ± 0.6 |
18.0 ± 0.8 |
|
HCT |
% |
18.5 ± 2.0 |
39.0 ± 3.0 |
51.0 ± 4.0 |
|
PLT |
10⁹/L |
65 ± 20 |
210 ± 40 |
480 ± 60 |
Khoom Specifications
|
Khoom |
Technical Specification |
|
Daim ntawv lub cev |
Npaj-rau- siv cov kev ncua ntawm tes |
|
Matrix |
Tib neeg thiab mammalian ntshav cov ntsiab lus |
|
Ntim |
12 × 3.0 mL vials rau ib lub thawv (4 × Tsawg, 4 × Li qub, 4 × siab) |
|
Kev kho dua tshiab |
Tsis xav tau |
|
Txuj kev zoo |
ISO 13485 Kev tsim khoom ib puag ncig |
Cia & Stability
Tsis qhib ciaKub: 2℃rau 8 degree. Tiv thaiv los ntawm lub teeb ncaj qha. Tsis txhob khov.
Kaw-Vial Shelf Life: 105 hnub txij li hnub tsim khoom thaum khaws cia tsis tu ncua ntawm 2℃txog 8 degree.
Qhib -Vial Stability: 14 hnub lossis 14 lub sijhawm ua piv txwv thaum khaws cia ntawm 2℃txog 8℃tam sim tom qab kuaj.
Cov xwm txheej thauj mus los: Thermal ntim nrog theem -hloov cov pob khoom txias uas tswj qhov txias sab hauv- cov saw kub.
Quality Assurance
Traceability:Cov nqi calibrated tiv thaiv kev txiav txim siab siv.
Kev sib txuam ntau:Inter-vial coefficient ntawm variation tswj nyob rau hauv CV <1.5%.
Batch Tso Tawm:Kev txheeb xyuas qhov tseeb ntawm ntau lub tshuab ntsuas ua ntej tso ntau ntau.
Cov ntaub ntawv pov thawj:Ntau-cov lus qhia tshwj xeeb uas muab nrog txhua yam khoom siv.
Khoom Description
Q: Yuav ua li cas vials yuav tsum tov ua ntej sampling?
A: Cia lub vial kom ncav cuag chav sov ($ 15^\\circ\\text{C}$–$30^\\circ\\text{C}$) rau 15 feeb. Yob lub vial kab rov tav ntawm xib teg 8-10 zaug, tom qab ntawd maj mam invert kawg- dhau- kawg 8-10 zaug. Tsis txhob tuav kom tsis txhob muaj cua nkag.
Q: Ntau npaum li cas - qhov ntsuas qhov ntsuas tshwj xeeb nyob qhov twg?
A: Cov ntawv txheeb xyuas qhia qhov ntsuas lub hom phiaj thiab kev tswj hwm tau ntim rau hauv txhua pob. Cov ntaub ntawv digital nkag tau los ntawm kev txheeb xyuas tus lej ntau.
Q: Cov kauj ruam twg yuav tsum tau yog tias rov qab poob rau sab nraud lub hom phiaj?
A: Txheeb xyuas cov txheej txheem sib tov, chav tsev kub, thiab lub vial tas sij hawm. Re- piv txwv lub vial. Yog tias qhov tseem ceeb tseem tsis tau pom dua - lub hom phiaj, tshawb xyuas cov raj dej rau cov npuas, tshuaj xyuas cov qib reagent, thiab kuaj lub vial tshiab uas tsis tau qhib.
Q: Dab tsi yog qhov yuav tsum tau pov tseg rau cov vials siv?
A: Kov qhib vials raws li cov qauv tshuaj lom neeg. Pov tseg cov kua seem thiab ntim raws li cov txheej txheem kuaj biohazard pov tseg raws tu qauv.
Q: Yuav ua li cas txias - saw kev ncaj ncees khaws cia thaum thauj mus los thoob ntiaj teb?
A: Kev xa khoom xa tuaj siv cov thawv ntim khoom siv nrog cov khoom txias txias - khaws cia, khaws cia qhov ntsuas kub ntawm 2℃-8℃ciam teb thoob plaws hauv huab cua thiab dej hiav txwv cargo txoj kev
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