Tri-Level Hematology Analyzer Control hian mihring leh rannung cellular components stabilized tak tak buffered fluid matrix-a suspended a awm a. Concentration level hrang hrang pathum-a siam-Low, Normal, leh High-he liquid reference material hian measurement precision a verify a, calibration stability a track a, automated blood cell counter hrang hrangah systemic operational errors a flag bawk.
Hematology Control / Calibrator te hi eng nge ni?
Clinical hematology-a quality management hi reference material hrang hrang pahnih a innghat a:
Controls te chu:Nitin testing sample mean value leh range limit hriat tawh te. Instrument system settings siam danglam ngai lovin hun kal zelah internal system precision leh operational consistency an enfiah thin.
Calibrator-te chu:Reference standard bikte chuan primary value bik an pe a. Reference method nena khaikhin chuan output dikna a awm theih nan physical measurement factor leh conversion coefficient te an siamrem thin.
Hematology Quality Control-a a chanvo
Three-level control matrix-a routine operation hian hnathawhna atana thil pawimawh tak takte a huam a:
Analytical Decision Ramri: 1.1.Pathological extreme-cytopenia na tak leh marked leukocytosis--ah te system performance chu clinical level pangngai nen a zirchiang thin.
Error hriatchhuah dan:Clinical report hmain fluidic micro-blockages, reagent oxidation, optical laser degradation, leh baseline electronic noise te a hriatchhuah tir thin.
Process zawm dan: 1.1.Operational shift tinah multi-level monitoring mumal tak neih ngai internal quality assurance procedures a tihlawhtling thin.
Control Level / A hman dan tur
Level 1 (A hniam) a ni.
Cell concentration tlahniam tura target a ni. Leukopenia, anemia, leh thrombocytopenia sample-te detection limit hniam zawk bulah measurement response a test thin.
Level 2 (Normal) a ni.
Physiological range hrang hranga target a ni. Nitin specimen run pangngaiah standard operational performance a enfiah thin.
Level 3 (High) a ni.
Cell count sang zawka target a ni. Leukocytosis emaw thrombocytosis emaw ang chi high-concentration scenario-ah linearity leh optical response a validate thin.
Control leh Calibrator te a ni
|
Mihring ziarang |
Hematology Control a ni |
Hematology Calibrator hmanga siam a ni |
|
Chhan |
Nitin system precision leh stability a enfiah thin |
Instrument dikna parameters a siamrem thin |
|
Zinzia |
Nitin emaw work shift khatah emaw analyze thin |
Calibration maintenance emaw shift drift emaw hnua process thin |
|
Data Format a ni |
Target mean chu upper/lower range nen paired a ni |
Target value pakhat chiah a awm |
|
Output chungchanga hmalakna |
Analytical variation beisei loh tak takte flag |
System gain factors te chu re-calculate leh overwrite a ni |
Hematology Analyzers hmantlak tak tak te
Cell chhiarna platform hrang hranga physical compatibility atana siam a ni a, hetiang hian:
- Electrical Impedance tehna a ni
- Optical Laser hmanga inthen darh a ni
- Photometric Hemoglobin hriat theihna
Value / Parameter pek chhuah te
|
Parameter a ni |
Hlawm khat |
A hniam (Level 1) 1.1. |
Normal (Level 2) a ni. |
A sang (Level 3) a ni. |
|
WBC a ni |
10⁹/L |
2.10 ± 0.40 |
7.20 ± 1.00 |
18.50 ± 2.50 |
|
RBC a ni |
10¹²/L |
2.30 ± 0.20 |
4.40 ± 0.30 |
5.30 ± 0.40 |
|
HGB |
g/dL a ni |
6.2 ± 0.5 |
13.5 ± 0.6 |
18.0 ± 0.8 |
|
HCT a ni |
% |
18.5 ± 2.0 |
39.0 ± 3.0 |
51.0 ± 4.0 |
|
PLT |
10⁹/L |
65 ± 20 |
210 ± 40 |
480 ± 60 |
Product chungchang chi hrang hrang
|
Thilneih |
Technical lam hawi zawng zawng |
|
Taksa lam Form |
Suspended cell suspension hman theihna tura inpeih- |
|
Matrix a ni |
Mihring leh rannung thisen elements |
|
Packaging a awm bawk |
Box khatah 12 × 3.0 mL vial (4 × A hniam, 4 × A pangngai, 4 × A sang) |
|
Reconstitution siam thar lehna |
Engmah a ngai lo |
|
Quality Standard a ni |
ISO 13485 siamna hmun a ni |
Storage & Stability a ni
Hmun hawn loh Storage: 2℃atanga 8℃thleng a ni. Direct light atanga venhim. Freeze suh.
Closed-Vial Shelf Life: A siam chhuah atanga ni 105 chhung chu 2℃atanga 8℃thlenga enkawl chhunzawm zel a nih chuan .
Open-Vial Stability a awm thei: Sampling hnu lawka 2℃atanga 8 degree-a dah a nih chuan ni 14 emaw 14 emaw sampling events a awm thei.
Transit Condition hrang hrang: Thermal packaging hmanga phase-change cold packs hmanga internal cold-chain temperature vawng reng.
Quality Assurance neih a ni
Trace theihna: 1.1.Reference determination method nena khaikhin chuan value te chu calibrate a ni.
Lot inmilna: 1.1.CV chhunga inter-vial coefficient of variation vawn reng chu < 1.5% a ni.
Batch-a tihchhuah tur:Lot tihchhuah hmaa testing system tam takah analytical verification neih a ni.
Data Documentation te chu a hnuaia mi ang hian a ni.Product kit tin nen hian lot-specific assignment tables supply a ni.
FAQ
Q: Sample lak hmain vial te hi engtin nge an inhmeh tur?
A: Vial chu room temperature ($15^\\circ\\text{C}$–$30^\\circ\\text{C}$) thleng minute 15 chhung dah la. Vial chu palm inkar ah vawi 8–10 vel horizontal-in roll la, chutah chuan end-over-end chu vawi 8–10 vel zawi zawiin invert rawh. Air entrainment awm loh nan tihnghing loh tur.
Q: Lot-specific assay value te hi khawiah nge an awm?
A: Parameter target leh control range tarlanna assay sheet te chu package tin chhungah pack a ni. Digital file te hi lot number verification hmanga hmuh theih a ni.
Q: Recovery hi target range pawna a tlak chuan eng step nge tih ngai?
A: Mixing kalphung, room temperature, leh vial expiration te enfiah rawh. Vial chu re-sample leh rawh. Value te off-target a nih chuan fluidic tubing-ah bubble awm leh awm loh enfiah la, reagent level enfiah la, control vial hawn loh thar test rawh.
Q: Vial hman tawhte chu engte nge paih chhuah ngai?
A: Vial hawn tawhte chu biological specimen angin handle. Liquid remnants leh packaging te chu standard laboratory biohazard disposal protocol angin paih vek tur a ni.
Q: International transport-ah hian engtin nge cold-chain integrity hi an vawn reng?
A: Shipment-ah hian insulated container configurations, cold-storage packs fitted an hmang a, boruak leh tuifinriat cargo route zawng zawngah 2℃–8℃temperature boundary mamawh chu a humhim a ni
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