Tri-Level Hematology Analyzer Control erimu ebitundu by’obutoffaali bw’omuntu n’ebisolo ebiyonka ebitebenkedde ebiyimiriziddwa mu matrix y’amazzi agabuffered. Ekoleddwa mu mitendera esatu egy’enjawulo egy’obungi-Low, Normal, and High-ekintu kino eky’amazzi ekijuliziddwa kikakasa obutuufu bw’okupima, erondoola okutebenkera kw’okupima, era ne kiraga ensobi z’enkola y’emirimu mu kubala obutoffaali bw’omusaayi mu ngeri ey’obwengula.
Ebifuga / Ebipima omusaayi (Hematology Controls / Calibrators) Biki?
Enzirukanya y’omutindo mu by’omusaayi mu bujjanjabi yeesigamye ku bintu bibiri eby’enjawulo ebijuliziddwa:
Ebifuga:Sampuli z’okugezesa buli lunaku nga zirina emiwendo gya wakati egyamanyi n’ekkomo ly’obuwanvu. Balondoola obutuufu bw’enkola ey’omunda n’obutakyukakyuka bw’emirimu okumala ekiseera awatali kukyusa nteekateeka za nkola ya bikozesebwa.
Ebipima:Emitendera egy’okujuliza egyaweebwayo egyaweebwa emiwendo egy’enjawulo egy’olubereberye. Batereeza ensonga z’okupima okw’omubiri n’emigerageranyo gy’okukyusa okukakasa nti ebifulumizibwa bituufu okusinziira ku nkola z’okujuliza.
Omulimu mu kulondoola omutindo gw’omusaayi
Enkola eya bulijjo eya matrix y'okufuga ey'emitendera esatu-gikwata ku byetaago ebikulu eby'emirimu:
Ensalo z’okusalawo mu kwekenneenya:Akebera enkola y’enkola ku pathological extremes-nga severe cytopenia ne marked leukocytosis-alongside normal clinical levels.
Okuzuula Ensobi:Ezuula micro-blockages ez’amazzi, reagent oxidation, optical laser degradation, n’oluyoogaano lw’ebyuma olusookerwako nga tebannaba kukola lipoota ya bujjanjabi.
Okugoberera enkola:Atuukiriza enkola z’okukakasa omutindo munda ezeetaaga okulondoola buli kiseera ku mitendera mingi-mu buli nkyukakyuka y’emirimu.
Emitendera gy'okufuga / Okukozesa
Omutendera 1 (Wansi) .
Egendereddwamu okukendeeza ku bungi bw’obutoffaali. Agezesa okuddamu okupima okumpi n’ekkomo erya wansi ery’okuzuula ku sampuli za leukopenia, anemia, ne thrombocytopenia.
Omutendera 2 (Ogwa bulijjo) .
Egendereddwamu ku bitundu by’omubiri (physiological ranges). Alondoola enkola y’emirimu eya mutindo mu kiseera ky’okudduka kwa bulijjo okwa buli lunaku.
Omutendera 3 (Waggulu) .
Egendereddwamu omuwendo gw’obutoffaali ogw’amaanyi. Akakasa linearity n’okuddamu okw’amaaso mu kiseera ky’embeera z’obungi-concentration nga leukocytosis oba thrombocytosis.
Okufuga vs. Kalifuuwa
|
Engeri |
Okufuga omusaayi |
Ekyuma ekipima omusaayi |
|
Omugaso |
Alondoola enkola ya buli lunaku entuufu n’obutebenkevu |
Atereeza ebipimo by’obutuufu bw’ebikozesebwa |
|
Emirundi |
Yeekenneenyezebwa buli lunaku oba buli ssifiiti y’omulimu |
Ekolebwa oluvannyuma lw’okuddaabiriza calibration oba shift drift |
|
Enkola ya Data |
Target mean eyungiddwa ku range eya waggulu/wansi |
Omuwendo ogugendererwa ogutali gukyukakyuka ogumu |
|
Ekikolwa ku bifulumizibwa |
Flags enjawulo mu kwekenneenya ezitasuubirwa |
Re-bala n'okuwandiika ku nsonga z'amagoba g'enkola |
Ebikebera omusaayi ebikwatagana
Ekoleddwa okusobola okukwatagana mu mubiri mu mikutu gyonna egy’okubala obutoffaali nga ekozesa:
- Okupima obusobozi bw’amasannyalaze
- Okusaasaana kwa Layisi okw’amaaso
- Okuzuula Hemoglobin mu ngeri ya Photometric
Emiwendo / Ebipimo ebiweereddwa
|
Parameter |
Omunwe |
Wansi (Omutendera 1) . |
Kya bulijjo (Omutendera 2) . |
Waggulu (Omutendera 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 |
Ebikwata ku Bikozesebwa
|
Eby'obwa nannyini |
Ebikwata ku by’ekikugu |
|
Enkula y’Omubiri |
Mwetegefu-okukozesa-okuyimirizaawo kw'obutoffaali obuyimiriziddwa |
|
Matrix (Matrix) nga |
Ebintu ebikola omusaayi gw’omuntu n’ebisolo ebiyonka |
|
Okupakinga ebintu |
Ebidomola bya 12 × 3.0 mL buli bbokisi (4 × Wansi, 4 × Bwa bulijjo, 4 × Waggulu) |
|
Okuddamu okukola ssemateeka |
Tewali n’emu yeetaagibwa |
|
Omutindo gw'omutindo |
ISO 13485 embeera y’okukola ebintu |
Okutereka & Okutebenkera
Okutereka Okutaggulwawo: Diguli 2 okutuuka ku diguli 8 . Kuuma okuva ku kitangaala ekitereevu. Tofuuka bbugumu.
Closed-Obulamu bw'Eccupa: Ennaku 105 okuva ku lunaku lw'okufulumya nga ekuumibwa obutasalako ku diguli 2 okutuuka ku diguli 8 .
Open-Okutebenkera kw'Ekiveera: Ennaku 14 oba ebibaddewo mu kutwala sampuli 14 nga biterekeddwa ku diguli 2 okutuuka ku diguli 8 amangu ddala nga bamaze okutwala sampuli.
Embeera z’okutambuza abantu: Okupakinga okw'ebbugumu nga kulina phase-change cold packs okukuuma ebbugumu ery'omunda erya cold-chain.
Okukakasa omutindo
Okulondoola:Emiwendo egyali gipimiddwa okusinziira ku nkola z’okusalawo ebijuliziddwa.
Okukwatagana kw’Ekibanja:Inter-vial coefficient of variation ekuumibwa munda mu CV < 1.5%.
Okufulumya mu Batch:Okukakasa okwekenneenya ku nkola z’okugezesa eziwera nga tebannaba kufulumya looti.
Ebiwandiiko bya Data:Lot-emmeeza z'okugaba ez'enjawulo eziweebwa ne buli kiti ky'ebintu.
Ebibuuzo ebibuuzibwa
Q: Ebidomola birina kutabulwa bitya nga tebannaba kutwala sampuli?
A: Kiriza ekibbo kituuke ku bbugumu erya bulijjo ($15^\\circ\\text{C}$–$30^\\circ\\text{C}$) okumala eddakiika 15. Yiringisiza ekibbo mu ngeri ey’okwesimbye wakati w’engalo emirundi 8–10, olwo n’okyusa mpola enkomerero-ku-enkomerero emirundi 8–10. Weewale okukankana okuziyiza empewo okuyingira.
Q: Emiwendo gy’okukebera egy’enjawulo egya lot-gisangibwa wa?
A: Olupapula lw’okukebera olulaga ebigendererwa bya parameter n’ebifo ebifuga bipakiddwa munda mu buli package. Fayiro za digito zifunibwa nga oyita mu kukakasa ennamba za looti.
Q: Mitendera ki egyetaagisa singa okudda engulu kugwa ebweru w’ebigendererwa?
A: Kakasa enkola y’okutabula, ebbugumu ly’ekisenge, n’okuggwaamu kw’ekidomola. Ddamu-sample sampuli y'ekidomola. Singa emiwendo gisigala nga tegiriko-target, kebera fluidic tubing oba bubbles, kebera reagent levels, era ogezese control vial empya etagguddwawo.
Q: Biki ebyetaagisa okusuula ebidomola ebikozesebwa?
A: Kwata ebidomola ebiggule nga biological specimens. Suula ebisigalira by’amazzi n’okupakinga okusinziira ku nkola ezituufu ez’okusuula obulabe bw’ebiramu mu laboratory.
Q: Obutuufu bw’enjegere ennyogovu-bukuumibwa butya mu kiseera ky’entambula ey’ensi yonna?
A: Ebintu ebisindikibwa bikozesa ensengeka za konteyina ezitali za bbugumu eziteekeddwamu packs z’okutereka ennyogovu-, nga zikuuma ensalosalo y’ebbugumu eryetaagisa erya diguli 2 –8 mu makubo gonna ag’emigugu mu mpewo n’ennyanja
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