3-Part Hematology Analyzer Control hi automated hematology counter dik leh dik loh tehna atana stabilized blood cell suspension atanga tri-level reference material siam a ni.
Hematology Control / Calibrator te hi eng nge ni?
Hematology controls hi stabilized cellular suspensions a ni a, target value ruat sa hmangin instrument routine performance leh analytical precision enfiah nan hman a ni. Instrument setting leh baseline calibration factors siamremtu calibrator ang lo takin control te hi independent reference sample angin an thawk a, systemic drift, fluidic errors, leh reagent variation te chu internal system coefficient tihdanglam lovin an hmu thei a ni.
Hematology Quality Control-a a chanvo
Nitin Precision Verification: 1.1.Damlo sample test hmain fluidic, optical, leh impedance channel hrang hranga counting consistency a enfiah thin.
Analytical Error hriatchhuah dan:Signal drift, reagent chhiatna, light source decay, leh aperture clogging te hriatchhuahna kawngah a pui thin.
Regulatory zawm dan: 1.1.Laboratory accreditation protocol te thlawp turin documented quality reference data a pe thin.
Lot Transition tihdikna: 1.1.Reagent batch thlak danglam emaw, routine system maintenance emaw laiin measurement baseline continuity a evaluate thin.
Control Level / A hman dan tur
Level hniam zawk:Leukopenic, thrombocytopenic, leh anemic range-a tehna dikna, detection limit hniam zawk, leh linearity te a zirchiang thin.
Level pangngai: 1.1.Standard physiological reference interval chhungah instrument performance a enfiah thin.
Level sang tak: 1.1.Leukocytosis, thrombocytosis, leh polycythemia range-a upper linearity limit leh chhiar dikna a zirchiang thin.
Control leh Calibrator te a ni
|
Hmelhmang |
Hematology Control a ni |
Hematology Calibrator hmanga siam a ni |
|
Hnathawh hmasa ber |
Analytical precision kalpui mek chu a evaluate thin |
Baseline tehna scale a siam thin |
|
Execution neih tam dan |
Nitin emaw operating shift tin emaw a ni thei |
Periodic emaw post-maintenance emaw a ni |
|
Target pek a ni |
Statistical range a awm a, a chung leh a hnuai lam a awm bawk |
Reference value tihfel a ni |
|
Thil awmzia (Material State) a ni |
Tri-level stabilized cellular suspension a awm bawk |
Single-level reference tihthianghlim tawh |
|
System Inzawmna |
Settings thlak danglam lovin current error a report thin |
Internal calibration factors te a siamrem thin |
Hematology Analyzers hmantlak tak tak te
Standard isotonic diluent platform hmanga automated three{0}}part differential cell counter-a open leh closed vial sampling mode atan siam a ni.
Value / Parameter pek chhuah te
|
Parameter a ni |
Hlawm khat |
Level hniam (Mean ± SD) a ni. |
Level pangngai (Mean ± SD) a ni. |
Level sang tak (Mean ± SD) a ni. |
|
WBC a ni |
10^9/L |
2.1 ± 0.4 |
7.2 ± 0.8 |
19.5 ± 1.8 |
|
RBC a ni |
10^12/L |
2.35 ± 0.20 |
4.40 ± 0.30 |
5.50 ± 0.40 |
|
HGB |
g/dL a ni |
6.2 ± 0.4 |
13.5 ± 0.6 |
17.8 ± 0.8 |
|
MCV a ni |
fL |
68.0 ± 4.0 |
88.0 ± 4.0 |
100.0 ± 5.0 |
|
PLT |
10^9/L |
75 ± 15 |
210 ± 30 |
480 ± 50 |
|
LYM% a ni. |
% |
15.0 ± 5.0 |
28.0 ± 6.0 |
50.0 ± 8.0 |
|
MID% 100% a ni. |
% |
6.0 ± 3.0 |
8.0 ± 3.0 |
12.0 ± 4.0 |
|
GRAN% 100% a ni. |
% |
79.0 ± 8.0 |
64.0 ± 7.0 |
38.0 ± 6.0 |
Product chungchang chi hrang hrang
|
Thilneih |
Technical lam hawi zawng zawng |
|
Taksa lam Form |
Mihring leh rannung cellular elements te chu stabilized liquid suspension a ni |
|
Pack Configuration a awm bawk |
Tri-Level Pack (1 Low, 1 Normal, 1 High) emaw level khata pack emaw a ni thei |
|
Volume chu fill rawh |
Vial khatah 3.0 mL a ni |
|
Closed-Vial Shelf Life |
siam ni atanga ni 105 chhung a ni |
|
Open-Vial Stability a awm thei |
Ni 14 chhung chu 2℃atanga 8℃thlenga vawn reng a ni |
|
Temperature Range a ni |
Storage leh shipment chu 2℃atanga 8℃thleng a ni |
Storage & Stability a ni
A dahna Temperature: 1.1.2℃leh 8℃inkar ah awm chhunzawm zel tur a ni . Freezing temperature-ah dah suh.
Light Exposure: A chhuahna tur hmun:Vial te chu original outer packaging chhungah direct light exposure hla takah dah rawh.
Mixing Protocol chu: 1.1.Vial chu mixing hmain minute 15 chhung ambient room temperature (15℃to 30℃) thleng turin dah la. Vial chu palm inkar ah horizontal-in roll la, sediment chu a fully resuspended hma loh chuan zawi zawiin invert rawh. Mechanical foaming awm loh nan nasa taka tihnghing loh tur.
Quality Assurance neih a ni
Hriselna testing: 1.1.Donor thisen unit-te chu HBsAg, anti-HCV, leh anti-HIV antibodies an nei lo tih an hmuchhuak.
Value Assignment pek dan tur:Standard reference method leh calibrate laboratory counter hmanga value siam te.
Thil siam chhuah dan: 1.1.In vitro diagnostic products atana ISO 13485 quality system hnuaia thawk facility chhunga siam leh package-a dah a ni.
FAQ
Q: Closed-vial shelf life chu engzat nge ni?
A: Material chu 2℃leh 8℃inkar a nih chuan a siam chhuah atanga ni 105 chhung target value stability a vawng reng thin .
Q: Material chu hawn hnuah eng chen nge hman theih a nih?
A: Vial hawn chuan ni 14 emaw sampling entry 14 emaw chhung target stability a vawng reng a, chu chu recapped nghal a, 2℃atanga 8℃storage-a dah leh a nih chuan a ni.
Q: Shelf life rei zawk nan product hi frozen theih a ni em?
A: Freezing hian cellular structure a tichhia a, cell lysis a thlen a, chu chuan material chu chhiar dik theih nan a dik lo a ni.
Q: Aspiration hmaa inbuatsaihna dik tak chu eng nge ni?
A: Vial chu room temperature-ah minute 15 chhung equilibrate la, chutah chuan palm inkarah zawi zawiin roll la, invert end-over-end chu cellular sediment chu air bubble awm lovin a suspended kim vek thlengin.
Q: Engvangin nge target parameters hi digit pakhat ni lovin value range anga pek a nih?
A: Target parameter-ah hian counting channel hrang hrang, optical system, leh ambient measurement environment hrang hranga operational variance beisei turte account turin upper leh lower limit a awm a.
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