WNR Lyse Reagent for Sysmex 5-Part Hematology Analyzers hian thisen sen chu a thlangin a lyse a, chutih rualin thisen var leh nucleated red blood cells (NRBC) te chu optical differential analysis atan a humhim bawk. Solution hian target osmolality leh pH balance a vawng reng a, hei hian WNR channel-a scattergram gating dik tak a neih theih nan a pui a ni.
Hematology Analyzer Lyse Reagent hi eng nge ni?
5-part differential blood analysis-ah chuan lyse reagent hian erythrocyte membrane puitling tak takte chu a tichhia a, bound hemoglobin a tichhuak a, semiconductor laser detection hnuaiah WBC leh NRBC structure te chu fluorescence nucleic acid staining atan a condition a ni.
Hematology Analysis-a hman dan tur
WBC & NRBC inthlauhna: 1.1.Lyses hian RBC te chu a puitling a, intact leukocytes leh nucleated RBCs te chu WNR scattergram-a optical quantification atan a isolate thin.
Hemoglobin hriatfiah dan:Hemoglobin chhuak chu 555 nm absorbance-a tehna photometrically stable compound-ah a chantir thin.
Analyzer Series pawh a inmil thei
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Sysmex XN Series a ni |
XN-550, XN-1000, XN-2000, XN-3000, XN-9000 te a ni |
|
Sysmex XN-L Series a ni |
XN-330, XN-350, XN-450, XN-550 te a ni |
|
Sysmex XS Series a ni |
XS-500i, XS-800i, XS-1000i te pawh a awm bawk |
Product chungchang chi hrang hrang
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Technical Parameter a ni |
A sawifiahna |
Standard / Thiltih dan |
|
Taksa lam Form |
Liquid thianghlim, particle-free |
Mit hmuh theiha enfiah |
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pH (25℃) a ni. |
4.80 ± 0.15 |
Potentiometric hmanga teh a ni |
|
Osmolality (osmolality) a ni |
180 ± 10 mOsm/kg a ni |
Freezing point atanga lo chhuak a ni |
|
Conductivity (25℃) a ni. |
12.5 ± 0.5 mS/cm a ni |
Conductivity meter a ni |
|
Background WBC |
0.1 × 109/L aia tlem emaw, a tlukpui emaw a ni |
Automated counter hmanga siam a ni |
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Background RBC a ni |
0.02 × 1012/L aia tlem emaw, a tlukpui emaw a ni |
Automated counter hmanga siam a ni |
|
Background HGB |
1.0 g/L aia tlem emaw, a tlukpui emaw a ni |
Spectrophotometry (555 nm) hmanga tih a ni. |
|
Correlation Coefficient (R2) tih a ni. |
0.995 aia tam emaw, a tlukpui emaw |
Parallel clinical trial hmanga test neih a ni |
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A dikna (CV%) . |
1.2% aia tlem emaw, a tlukpui emaw |
Run 10 a zawnin a chhuak |
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Shelf Life hawn loh |
Thla 24 (2℃- 35℃) a ni. |
Kum upa lam test chak zawk |
|
Open-Bottle Stability a awm theih nan |
Ni 60 chhung (15℃- 30℃) a ni. |
Real-time stability tracking a ni |
Thil pawimawh tak tak
Scattergram Alignment a awm dan tur: 1.1.Osmolality leh pH tolerance chu ± 1% chhunga control a ni a, baseline gating limit nena inmil tur leh cluster overlap venna tur a ni.
Sub-Micron Filtration hmanga tihchhuah dan:0.1 μm inline membrane hmanga process a ni a, insoluble micro-particles te tihbo nan leh fluidic tube clogging ven nan.
Buffer awm zat: 1.1.Organic acid buffering system hian ambient temperature sang takah extended operational runs neih chhungin target pH a vawng reng thin.
Optical Clarity atanga thlir chuan:Hemoglobin hmuhchhuahnaah photometric offset a awm loh nan batch khatah absorbance baseline verified a ni.
Package & Storage te a awm bawk
Size awm thei te:4 L rigid HDPE bottle, 5 L flexible cubitainer, custom bulk packaging hmanga siam a ni.
Storage Condition hrang hrang: 1.1.2℃- 35℃a ni. Container chu direct light leh heat source atanga hla takah khar tur a ni.
A hman dan tur:Transit laiin freezing lakah venhim rawh. Installation hmain temperature equilibration chu 15℃- 30℃thleng phalsak rawh.
Thil siam & Supply Quality tha tak a ni
Tui kalphung: 1.1.Deionized supply, resistivity chu 18.2 MΩ·cm aia tam emaw, a tlukpui emaw-a vawn reng leh total organic carbon (TOC) < 10 ppb.
Cleanroom tihfai dan tur:ISO Class 8 (Class 100,000) controlled cleanroom environment-a siam leh bottle-a dah a ni.
Quality Management: 1.1.Production facility te hi medical devices atana ISO 13485 certified quality system hnuaiah an thawk a ni.
Batch Release Control dan tur: 1.1.Lot tin hian an thawn chhuah hmain physical parameter verification, background testing, leh parallel analyzer validation an nei vek a ni.
Hematology Reagents nena inzawm te
- Cell Diluent hi 5-Part Hematology Analyzers atan hman a ni
- FNR Lyse Reagent hmanga siam a ni
- SLS Hemoglobin Lyse Reagent hmanga siam a ni
- Enzymatic Probe hmanga tihfai theihna
FAQ
Q: Engtin nge he WNR lyse reagent hian Sysmex 5-part analyzer-ah cluster separation a vawng reng?
A: He formulation hian pH (4.80 ± 0.15) leh osmolality (180 ± 10 mOsm/kg) control khauh tak a nei a, hei hian RBC membrane dissolution nghet tak leh WNR channel-a laser light scattering awm reng a tichiang a ni.
Q: Micro-particle contamination hian fluidic tube blockage a thlen loh nan eng thilin nge a veng?
A: A siam chhuah lai hian liquid zawng zawng hi multi-stage 0.1 μm filtration system hmangin a kal tlang vek a. Batch release hian background count hi WBC tan 0.1 × 109/L leh RBC tan 0.02 × 1012/L hnuai lam khauh taka awm a ngai a ni.
Q: Reagent thlak dawnin adjustment emaw system recalibration emaw a ngai em?
A: Fludic recalibration emaw software setting siamthat emaw a ngai lo. Bottle cap assembly leh tube connector te hi standard analyzer intake port ah direct in a fit a ni.
Q: Eng evidence nge procurement order lian tak takte tan batch-to{1}}batch consistency a thlawp?
A: Production lot tin hi ISO 13485 protocol hmanga siam a ni a, conductivity, refractive index, leh density te automated inline monitoring hmanga siam a ni. Thil thawn apiangin physical leh operational test result kimchang tarlanna Certificate of Analysis (COA) a keng tel vek a ni.
Q: Distributor te tan eng OEM emaw bulk packaging duhthlan tur nge awm?
A: Standard supply format-ah hian 4 L HDPE bottle leh 5 L cubitainers a awm a. Private labelling, custom outer carton branding, leh bulk liquid drum shipment te chu dilna angin pek theih a ni.
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