3-Part Hematology Analyzer Control em i wanpela tri-level refrens materiel we ol i redim long ol 'stabilised blood cell suspensions' bilong skelim stretpela na stretpela bilong ol 'automated hematology counters'.
Wanem samting em ol 'hematology controls' / 'calibrators'?
Ol 'hematology controls' em ol 'stabilised cellular suspensions' wantaim ol 'target values' we ol i save yusim long sekim wok bilong ol instramen na 'analytical precision'. I no olsem ol 'calibrator', we i save stretim ol seting bilong ol instramen na ol 'baseline calibration factors', ol kontrol i save wok olsem ol indipenden refrens sempel long painim 'systemic drift', 'fluidic errors', na 'reagent variation' na i no senisim ol 'internal system coefficients'.
Rol long Hematology Kwaliti Kontrol
Precision Verification long olgeta de:Ol i save sekim wok bilong kaunim ol samting long ol 'fluidic', 'optical', na 'impedance' 'channels' pastaim long ol i skelim ol 'patient sample'.
Painimaut bilong ol asua long wok painimaut:Helpim long luksave long signal drif, bagarap bilong 'reagent', bagarap bilong lait sos, na 'aperture clogging'.
Reguletori Kompliens:Givim ol gutpela data bilong sapotim ol 'laboratory accreditation protocols'.
Lot Transisen Validesen:Skelim 'measurement baseline continuity' long taim bilong senisim ol 'reagent batch' o wok bilong lukautim sistem.
Kontrol Level / Aplikesen
Low Level:Skelim stretpela bilong skelim, daunim mak bilong painim, na 'linearity' insait long 'leukopenic', 'thrombocytopenic', na 'anemic'.
Nomal Level:Monitim pefomens bilong ol instramen insait long ol standet fisiolojikel refrens intaval.
Hae Level:Skelim ol 'upper linearity limits' na 'counting accuracy' long ol 'leukocytosis', 'thrombocytosis', na 'polycythemia'.
Kontrol na Kalibreta
|
Eria |
Hematology Kontrol |
Hematology Calibrator |
|
Namba wan wok |
Skelim stretpela wok painimaut |
Setim beslain mesamen skel |
|
Eksekyusen Frekwensi |
Olgeta de o olgeta operesen sif |
Periodik o bihain long -mentenens |
|
Taget ol i makim |
Statistikel mak wantaim mak antap na daunbilo |
Fiks refrens veliu |
|
Stet bilong ol samting |
Tri-level stabilized cellular suspension |
Purified single-level refrens |
|
Sistem Intaeksen |
Ripotim asua bilong nau na i no senisim ol seting |
Stretim ol intanel kalibresen fakta |
Ol masin bilong skelim blut we i stret wantaim
Ol i wokim bilong opim na pasim ol 'vial sampling modes' long ol 'automated three-part differential cell counters' yusim ol 'standard isotonic diluent platforms'.
Ol veliu / parameta we ol i makim
|
Paramita |
Yunit |
Low Level (Mean ± SD) |
Nomal Level (Min ± SD) |
Bikpela mak (Min ± SD) |
|
WBC |
10^9/L |
2.1 ± 0.4 |
7.2 ± 0.8 |
19.5 ± 1.8 |
|
RBC |
10^12/L |
2.35 ± 0.20 |
4.40 ± 0.30 |
5.50 ± 0.40 |
|
HGB |
g/dL |
6.2 ± 0.4 |
13.5 ± 0.6 |
17.8 ± 0.8 |
|
MCV |
fL |
68.0 ± 4.0 |
88.0 ± 4.0 |
100.0 ± 5.0 |
|
PLT |
10^9/L |
75 ± 15 |
210 ± 30 |
480 ± 50 |
|
LYM% |
% |
15.0 ± 5.0 |
28.0 ± 6.0 |
50.0 ± 8.0 |
|
MID% |
% |
6.0 ± 3.0 |
8.0 ± 3.0 |
12.0 ± 4.0 |
|
GRAN% |
% |
79.0 ± 8.0 |
64.0 ± 7.0 |
38.0 ± 6.0 |
Ol spesifikasen bilong prodak
|
Banis |
Teknikel Spesifikesen |
|
Fom bilong bodi |
Stabilis wara saspensen bilong ol sel element bilong man na animal |
|
Pack Configuration |
Tri-Level Pack (1 Low, 1 Normal, 1 High) o ol singel level pack |
|
Pulimapim volium |
3.0 mL long wan wan botel |
|
Vial Shelf Laip |
105 de stat long deit bilong wokim |
|
Open-Vial Stability |
14 de i stap long 2 digri i go long 8 digri |
|
Tempereja Range |
Stoa na salim long 2 digri i go long 8 digri |
Stoa na Stebiliti
Tempereja bilong putim:Kipim oltaim namel long 2 digri na 8 digri. Noken putim long ples we i kol tru.
Lait Eksposesen:Putim ol 'vials' insait long 'original auter packaging' longwe long lait.
Miksing Protokol:Larim botol i kamap long rum tempereja (15 digri i go inap 30 digri) inap 15 minit pastaim long yu miksim. Rolim botol i go stret namel long ol han bilong han na tanim isi isi inap long taim ol pipia i kapsait gen. Noken seksekim strong long stopim 'mechanical foaming'.
Kwaliti Asurens
Sefti Testing:Ol blut yunit bilong ol dona i no gat HBsAg, anti-HCV, na anti-HIV antibodi.
Value Assignment:Ol veliu we ol i kamapim long yusim ol standet refrens rot na ol 'calibrated laboratory counters'.
Sistem bilong wokim ol samting:Ol i wokim na putim insait long ol ples we i wok aninit long ISO 13485 kwaliti sistem bilong ol in vitro daignostik prodak.
FAQ
Q: Wanem em i 'closed-shelf laip bilong botol?
A: Dispela samting i save holim gutpela mak bilong en inap 105 de stat long taim ol i wokim taim ol i holim namel long 2 digri na 8 digri.
Q: Hamas taim ol i ken yusim dispela samting bihain long ol i opim?
A: Wanpela 'vial' we i op i save holim gut 'target stability' inap 14 de o 14 'sampling entris' taim ol i karamapim gen hariap na putim bek long 2 digri i go inap 8 digri stoa.
Q: Ol i ken putim dispela prodak long ais bilong mekim em i stap longpela taim moa?
A: Ais i save bagarapim ol sel straksa na i save mekim ol sel i bruk, na dispela i mekim na ol samting i no inap long kaunim stret.
Q: Wanem em i stretpela pasin bilong redim ol samting pastaim long 'aspiration'?
A: Putim 'vial' long rum tempereja inap 15 minit, na bihain rolim isi isi namel long ol han bilong yu na tanim arere bilong en- antap long- arere bilong en inap long taim ol 'cellular sediment' i hangamap olgeta na i no gat ol 'air bubbles'.
Q: Bilong wanem ol i givim ol 'target parameters' olsem wanpela 'value range' na i no wanpela 'single digit' tasol?
A: Ol mak bilong mak i gat antap na daunbilo mak bilong tingim ol samting we ol i ting bai kamap long ol narapela narapela rot bilong kaunim, ol optikal sistem, na ol ples bilong skelim ol samting.
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