G8 溶離液 HSi 第1液 (S)
Contents
1. 4 25 C RRR OTR ODE S Toe EE C LA ERRE 2 IR Co lt 11 HLC 72368 Format 610 ro xat 0 met JAH 979 IVAH L S Ssor otvqH S S dS9N OLVGH Z6 bLGL V38V W10 199991 67 0 l6 ov ete 659 0 S S 9LVS os ve vO 6 L 9LV1 ese 86 0 EL 3 tis or OE 0 9 O aly 96 it EZO Z O viv 00 0 00 0 0 0 di v3auv EGLES x 3WvN 1 08 0 XS89L L CN VO 90 1000 0l 90 L000 1S 6100 0N OL SOA NOIIVdOdHOO HOSOL Ly gL 60 60 2102 1H0d3H NI90190H3H09A19 Format 610 loo XSL xo X 9 0 JOH 8 9 LvqH xo s sor oLvaH xv s 4 9N 91 VQH Se LLEL V JHV W10 992 6 70 LZ6 ov 0 88 090 v s OLVS 80 1Z Gro S 91V1 tole 960 870 3 we ll OG O 870 atv 49 L ez o 90 viv 00 0 00 0 0 0 dd v3uv 3W11 x SWYN 1209 0 XS891 1 PN IVO vo 1000 al vo 1000 1S 4100 ON OL SO NOIIVHOdHOD HOSOL 66 90 60 0 clOZ LyOdIY NI90190H3H02A719 12 FP Total Area2. e e e 15 ER UI de Bel amp KET 0 amp b NE DW DIC rmm HH HH E esse used NE ERN MN areola A EPI EAE ES ee E ETS
3. l 0 1 13 1 HbAlc TLevel2 sA Total Area 500 2700 700 2500 Total Area sArc 324 50 9 2 652 54 9 7 939 78 9 8 1199 05 9 8 1552 53 9 9 1833 12 9 9 2104 36 9 9 2321 57 10 0 2610 74 10 0 2858 85 10 1 2 2 pg g sA sAk 0 10 2 3 1 9 44 4 3 102 3 2 8 6 2 6 4 96 9 3 7 8 2 8 3 98 8 4 6 10 1 10 2 99 0 5 5 11 9 12 1 98 3 6 4 13 6 13 9 97 8 7 3 15 4 15 6 98 7 8 2 17 2 17 4 98 9 9 1 19 0 19 3 98 4 10 0 20 4 E 3 HLC 723G8 HLC 723G7 HLC 723G8 HLC 723GHbV SA
4. 1 3 amp m 0021800 G8 HSi 1 X S 800 mLX 10 0021801 G8 HSi 2 S 800 mLX 10 0021802 G8 HSi 3 qr S 800 mLX 10 Standard Analysis Mode HLC 723G8 4 m HbA1c J 0018198 HbAlc 0021974 TSKgel G8 HSi 0021498 HSi YA IL VEY L 0018431 HSi YA IL VEY LL 0019550 5 4 30 4 25 3 6 s A 7 HPLC 1 0 6 3 G8 G8 BENS HSi 1366 S
5. HbA WEH JCCLS CRM 004a JCCLSCRM 004a JDS LOT 2 LOT 3 HLC 723G8 HLC 723G7 HLC 723G8 TT S A c 2 0 4 0 6 0 8 0 10 0 12 0 14 0 HLC 723G7 HLC 723G8 HLC 723GHbV 14 0 12 0 10 0 8 0 HLC 723G8 6 0 4 0 2 0 S Aic 2 0 40 6 0 8 0 10 0 12 0 14 0 HLC 723GHbV 14 1 n 10 3 s A n 10 Low Medium High Mean 5 17 7 47 9 76 SD 0 05 0 05 0 05 CV 0 97 0 67 0 51 2 n 10 2 1 1 10 s A Low High Mean 5 21 9 75 SD 0 03 0 07 CV 0 58 0 72 15 10 g L
6. e e e vica N A e e e e JN e e
7. mg dL mg dL g L X 100 1 10 sg L 0 25 g L 0 20 g L g L Hb Hb A 0 00 0 05 0 10 0 15 0 20 0 25 g L Hb 0 00 0 05 0 10 0 15 0 20 0 25 gL 2 0 19 g L 0 20 g L FLU 2430 RILEY 2 vi 0 5 g L 3 HbF 16 EDTA NaF 25 24
8. 1 k pN HpA L A REM HbA s A HbA LA 1 3 sA LA E s A LAi s A d s Ai 1 0 2
9. 4 14 Safety Precautions To help protect you and or your property from potential damage and ensure personal safety please read this IFU thoroughly before using the product Notational Convention Notation Explanation Z CAUTION Indicates a hazard with a low level of risk which if not avoided could result in minor or moderate injury Z N CAUTION E Use only in well ventilated areas In case of insufficient ventilation flammable and toxic solvents can cause fire explosion or poisoning W First Aid Skin exposure Wash exposed area with plenty of soap and water Eye exposure Open eyes as wide as possible and wash with clean water for at least 15 minutes Immediately call for medical attention Ingestion Please wash mouth with excess water and immediately call for medical attention E Do not spill solvents Spillage and leakage can cause fire electric shock poisoning injury and corrosion Wear appropriate protective gear when cleaning up a spill E Wear eye protection and protective gloves Organic solvents and acids are harmful and should not come in direct contact with the skin E Handle package with care Inappropriate handling may cause rupturing and or spattering of the product E Only use this product as intended This product is intended for in vitro diagnostic use for the measurement of HbA in blood specimens E Proper disposal Dispose in accord
10. G8 HSi 2821 S G8 HSi 3 S HbF s A TotalA 8 G8 YAH HSi TSKgel G8 HSi HbAlc J HbAle HSi HLC 723G8 VY HLC 723G8 STOP OK Co N lt lt on wm Ve
11. HLC 723G8 2 0 4 0 6 0 8 0 10 0 12 0 14 0 HLC 723G7 The correlation between the s A 96 for HLC 723G8 and HLC 723GHbV A1c2 2 analyzers S A c HLC 723G8 2 0 40 6 0 8 0 10 0 12 0 14 0 HLC 723GHbV 17 Precision 1 Intra assay n 10 The intra assay precision n 10 factors of the s A for three types of control samples are shown below Low Medium High Mean 5 47 7 68 9 90 SD 0 05 0 06 0 00 CV 0 91 0 78 0 00 2 Inter assay n 10 The inter assay precision n 10 factors measured once a day for a 10 day period of the s A 96 for two types of control samples are shown below Low High Mean 5 52 9 88 SD 0 04 0 06 CV 96 0 72 0 61 18 Interferences A substance is considered to interfere when the recovery of a known specimen falls outside a 10 acceptability range Concentrations of interfering substances in this IFU are in units of g L Conversion to units of mg dL may be made using the following equation mg dL g L X 100 1 No effect was observed below 10 g L for glucose 0 25 g L for sodium cyanate and 0 20 g L for acetaldehyde Glucose Effect of labile Aic Control concentration g L Sodium cyanate Effect of carbamyl Hb Control concentration g L Acetaldehyde Effect of aldehyde Hb Hb 0 00 0 05 0 10 0 15 0 20 0 25 Control concentration g L 2 No effect was observed fo
12. Service amp Support sektionen Trykte brugsanvisninger kan rekvireres pr fax 32 13 66 47 49 eller e mail info raqa eu tosoh com Nuv rende Version G8S 01010 instrukcja U ytkowania w r znych j zykach jest dost pna na naszej stronie internetowej www tosohbioscience eu w zak adce Service amp Support Serwis i Wsparcie O wersj papierow mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem info raqa eu tosoh com Aktualna Wersja G8S 01010 Bedienungsanleitungen in verschiedenen Sprachen sind auf unserer Webseite www tosohbioscience eu Im Kapitel Service amp Support erh ltlich Ein Papierexemplar erhalten Sie auf schriftliche Anfrage an Faxnummer 32 13 66 47 49 oder per E Mail an info raqa eu tosoh com Aktuelle Version G8S 01010 As instruc es de utilizacao encontram se disponiveis em diversos idiomas no nosso sitio www tosohbioscience eu na sec o Service amp Support Servi os e Assist ncia Pode ainda obter uma vers o em papel atrav s do fax 32 13 66 47 49 ou do email info raqa eu tosoh com Versao Actual G8S 01010 Oa ipsire ric Odnyieg xp on os ToAAEc YAOOogc OTN Siadiktuakr rorroGeo a pa www tosohbioscience eu otnv v rnra Service amp Support Mrrops re va AdBete rnv EVTUTn popp urroB ANovrac alrnon p ow pag otov api8u 32 13 66 47 49 u ow nAckrpoviko TdXU5pOHgloU info raga eu tosoh com Tp xouca Ek8oon G8S 010
13. 3 Reference Data seen 20 Measurement Values no moe 20 Evaluation of Results Mee 20 2 Expected Values see 4MMMMMHSeHmHHHH 21 Performance Characteristics eee eee eee eee eee ee eee 21 Precision e e eK RMMMMMMHMHHHHHHRMMRHMMMMHMHHHH 23 Interferences eee eee eee eee eee eee eee eee eee eee eee eee eee eee eee eee 24 Specimen Collection and Handling eee 25 Revised in April 2012 1 Introduction The G8 Elution Buffer HSi is designed exclusively for use with the Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 referred to as HLC 723G8 in the IFU which is based on the principle of High Performance Liquid Chromatography assay It is not designed for and should never be used with any other type of system The G8 Elution Buffer HSi is intended for in vitro diagnostic use for the measurement of hemoglobin A HbA in blood specimens Glycohemoglobin GHb is a general term for complexes where the whole blood glucose is non enzymatically bound to the or chains of human hemoglobin Within these complexes HbA which is a complex of glucose and the N terminus of the chain is the most quantitatively prevalent HbA is non enzymatically synthesized in two steps Step 1 The glucose aldehyde group reacts with the free amino group on the valine comprising the N terminus of the 5 chain to form the Schiff base labile HbA L A Step 2 Stable ketoamine stable HbA s A is then formed by a re
14. raqa eu tosoh com Aktu lna Verzia G8S 01010 Eri keeltes kasutusjuhendid on saadaval meie veebilehel www tosohbioscience eu alajaotuses Service amp Support Paberkandjal versiooni saab tellida faksinumbril 32 13 66 47 49 v i e posti teel info raqa eu tosoh com Kehtiv Versioon G8S 01010 Bruksanvisning p flera spr k finns att tillg p v r webbplats www tosohbioscience eu under rubriken Service amp Support En pappersversion kan erh llas per fax 32 13 66 47 49 eller e post info raqa eu tosoh com Aktuell Version G8S 01010 Les instructions d utilisation sont disponibles en plusieurs langues sur notre site web www tosohbioscience eu dans la rubrique lt Service amp Support gt Vous pouvez obtenir un exemplaire papier par fax au n 32 13 66 47 49 ou par e mail l adresse info raqa eu tosoh com Version Actuelle G8S 01010 AHasznalati utasit s t bb nyelven el rhet websz jtunkon www tosohbioscience eu a Service amp Support Szolgaltatas s T mogat s szekci alatt Nyomtatott v ltozat ig nyelhet faxon a 32 13 66 47 49 es telefonsz mon vagy e mailben info raqa eu tosoh com Aktu lis V ltozat G8S 01010 Istruzioni per l Uso in diverse lingue sono disponibili sul nostro sito web www tosohbioscience eu alla sezione Service amp Support Versione cartacea pu essere richiesta via fax al 32 13 66 47 49 o via e mail a jnfo
15. raqa eu tosoh com Versione Attuale G8S 01010 Naudojimo instrukcijas vairiomis kalbomis galite rasti m s tinklalapio www tosohbioscience eu skyriuje Service amp Support Popierine versij galite gauti faksu 32 13 66 47 49 arba el pa tu info raqa eu tosoh com Naujausia Versija G8S 01010 Symbols on the product labels C European Conformity Catalogue number Part number Use by date For specified column lot only Manufacturer In vitro diagnostic medical device Batch code Lot number SN Serial number Column number Authorized representative in the European Community Consult instructions for use Temperature limitation NET Net volume after reconstitution for lyophilized material OO ON O Q Q N e a X OMAN OO ON gt CONTENTS Introduction eens ee 15 Prior to Use Wooo 16 i Warnings and Precautions Deere cece cree ener cece ee sesccessevene 16 Content eee eee eee eee eee eee ee ee eee ee ee eee eee eee eee ee eee eee ey 16 Related Components eer eee eee eee eee eee eee eee eee eee ee eee ee 17 1 Storage and Stability eee eee eee eee eee eee ee eee eee eee ee eee ee 17 P Specimens eee eee eee eee eee ee eee eee ee eee ee eee eee eee eee eee eee 17 3 Assay Principle eee reer rere eee eee eee eee ee eee eee eee eee eee eee eee 47 Installation ro 17 f Assay Procedures e 18 Precautions for US 18
16. sS gt a 8 20 a M w oo lt gt Sans co ecc I 9 4 oog scarce lt lt q d o 13 Measurement Values Measurement values 96 indicate the percentage of each peak in relation to the Total Area excluding the front peak FP Note the minimum unit of measurement displayed is 0 1 96 14 Evaluation of Results Quality Control In order to monitor and evaluate the precision and analytical performance it is recommended that control samples should be run daily If one or more control sample value s is out of the acceptable range it is necessary to investigate the validity of the calibration curve before reporting patient results Standard laboratory procedures should be followed in accordance to the strictest regulatory agency under which the laboratory operates 15 Expected Values Reference ranges non diabetic HbA s A 4 0 6 0 mean 5 0 SD 0 5 Ref American Diabetes Association Standards of medical care for patients with diabetes mellitus Diabetes Care 2000 23 Suppl 1 S32 42 The values referred to within this document have been determined with a NGSP certified method It is known that the relationship between HbA results from the NGSP network 96 and the IFCC network mmol mol is expressed by using the following equation See http www ifcchba1c net IFCC 08 asp NGSP 0 09148 X IFCC 2 152 16 Performance Characteri
17. 10 Instructiuni de utilizare in diverse limbi sunt disponibile pe site ul nostru www tosohbioscience eu la sectiunea Service amp Support Service si asisten tehnic O versiune pe h rtie poate fi ob inut comand nd o prin fax la 32 13 66 47 49 sau prin e mail la info raqa eu tosoh com Versiune Actuala G8S 01010 Instructions For Use in multiple languages are available on our website www tosohbioscience eu under the Service amp Support section A paper version can be obtained by fax 32 13 66 47 49 or e mail info raga eu tosoh com Actual Version G8S 01010 Vegjezi na navodila za uporabo so na voljo na na i spletni strani www tosohbioscience eu v razdelku Service amp Support Servis in podpora V papirni obliki jih lahko prejmete po faksu 32 13 66 47 49 ali elektronski posti info raga eu tosoh com Aktualna Razli ica G8S 01010 Las instrucciones de uso est n disponibles en diferentes idiomas en nuestra pagina web www tosohbioscience eu en la secci n de Service amp Support Servicio y Soporte Tambi n podemos enviarle una versi n impresa a trav s del fax 32 13 66 47 49 o por correo electr nico info raqa eu tosoh com Versi n Real G8S 01010 N vod na pouzitie vo viacerych jazykoch je dostupny na na ej web str nke www tosohbioscience eu v sekcii Service amp Support Wtla amp en verziu mo no ziska faxom 32 13 66 47 49 alebo cez e mail info
18. 80 Tessenderlo Belgium Phone 32 13 66 88 30 Fax 32 13 66 47 49 This manual may not be reprinted or copied in whole or in part without written consent of Tosoh Corporation The contents of the manual are subject to change without notice HLC TSKgel HLC is the registered trademark of Tosoh Corporation in Japan TSKgel is the registered trademark of Tosoh Corporation in Japan United States China etc Printed in Japan T1205 15
19. I EIE E E ETT RRR EAR RE ER EER ER EE TK PT sesessecocssssscccossssssscocsssssssooeoes 3 EIE 9 POLO LR FC 10 WREST iss Ng vins ME REUS E E 11 LEE 12 EET 13 swasauasapawasasqascqkupawusqaskassaawasas 14 TT TK 15 rere eee errr rere ere ee reer errr e er eerie 16 ere mo ND m OND a 2012 4 2009 8 1 HLC 723G8 HLC 723G8 4 GHb HO N HbAi HbA 2
20. Rev DL008J010 DLO008E010 HLC 723G8 TOSOH Automated Glycohemoglobin Analyzer HLC 723G8 Instructions For Use G8 HSi 1 S 2 M S 3 M S G8 Elution Buffer HSi No 1 S No 2 S No 3 S C TOSOH CORPORATION TOSOH e e e e e e e
21. a 9 HLC 723G8 10 1 T amp BEWeO EHI t Z O Pe HLC 793G8 2 UE T dE ES fg BRE Os 26b HLC 723G8 TSKgel G8 HSi HSi Pr vifi s LL EPN A npa 1 G8 AER HSI 3 lt ot A column OND 4ny hha De 4 OEE SEVIS Crees el Mi avidi aE a x s Gs Tee TIT EN 3 7
22. action known as the amadori rearrangement Due to the fact that L A the intermediate product of this reaction changes rapidly in response to the changes in whole blood glucose concentrations S A is now generally used to measure HbA It provides the best indication of average glucose levels over the most recent 1 to 3 month period because it does not fluctuate in response to physiological factors In the past it was difficult to achieve quick separation of L A and S A on a column therefore sample pretreatment to remove L A was necessary before assaying s A The new Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 features quick separation of L A and s A on the column 1 0 min with no need for sample treatment when assaying s A 2 Prior to Use Inspect the packaging and the exterior of the aluminum pack for any signs of damage prior to use If any damages are visible contact your local Tosoh sales representative Confirm the following document is included in the package Instructions For Use 1 copy in each box 3 Warnings and Precautions 1 This product is for in vitro diagnostic use only 2 This product is intended for use on the Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 Standard Analysis Mode only 3 Do not use this product beyond the expiration date 4 Content The following types of elution buffers are designed for exclusive use with the HLC 723G8 Catalogue No Description Packag
23. ance with local laws and regulations NOTE Keep this IFU with the product for future reference EU rev G8S 01010 Emponewckw norpe6urenn Evrop amp ti z kaznici Europ iske kunder Europ ische Kunden European customers Eupurraior mAGrc Clientes europeos Euroopa kliendid Consommateurs europ ens Eur pai gyfelek Clienti europei Europos klientai Eiropas klienti Klienci europejscy Clientes europeus Clienti europeni Evropski kupci Eur pski z kazn ci Europeiska kunder Vucrpyku sa ynorpe6a Ha Da3TIMHHM eau ca Ha pasnonoxkeHue Ha HalM ye6caMT www tosohbioscience eu B paanena Momo n nonnptxxa Service amp Support XapTMeHO konne Moxe na 6bge nonydeHo Ha fax 32 13 66 47 49 unu e mail info raqa eugtosoh com AkTyanHa Bepcus G8S 01010 Lietosanas instrukcijas dazadas valodas ir pieejamas m su interneta vietn www tosohbioscience eu sada Service amp Support Apkalpo ana un Atbalsts Drukatu versiju iesp jams sa emt pa faksu 32 13 66 47 49 vai e pastu info raqa eu tosoh com Aktu l Versija G8S 01010 Navod k pouziti v r znych jazycich je dostupny na na ich webovych str nk ch www tosohbioscience eu v sekci Service amp Support Ti t nou verzi m ete obdr et faxem slo 32 13 66 47 49 nebo e mailem info raga eu tosoh com Aktu ln Verze G8S 01010 Flersprogede brugsanvisninger findes pa vores hjemmeside www tosohbioscience eu under
24. e contents 0021800 G8 Elution Buffer HSi No 1 S 10800 mL 0021801 G8 Elution Buffer HSi No 2 S 10X800 mL 0021802 G8 Elution Buffer HSi No 3 S 10800 mL G8 Elution Buffer HSi are organic acid buffers Each contains less than 0 05 sodium azide as a preservative Assay mode Standard Analysis Mode Applicable analyzers Tosoh Automated Glycohemoglobin Analyzer HLC 723G8 5 Related Components Catalogue No Hemoglobin A1c Calibrator Set 0018767 Hemoglobin A1c Control Set 0021974 TSKgel G8 HSi 0021498 HSi Hemolysis amp Wash Solution L 0018431 HSi Hemolysis amp Wash Solution LL 0019550 6 Storage and Stability All unopened materials are stable until the expiration date on the label when stored at 4 to 30 C The expiration date indicated on the package box and aluminum pack labels Stable for 3 months after opening when stored at 4 to 25 C 7 Specimens Whole blood samples 8 Assay Principle The HLC 723G8 is based on the High Performance Liquid Chromatography HPLC principle Cation exchange columns employ the differences in ionic interactions between hemoglobin components to separate them into a total of six fractions in a span of 1 0 min A step gradient elution is used to separate and assay HbF s A and Total A with three types of G8 Elution Buffer HSi G8 Elution Buffer HSi No 1 2 and 3 S of different salt concentrations 9 Installation Be sure to read the IFU includ
25. ed with the G8 Elution Buffer HSi TSKgel G8 HSi Hemoglobin A1c Calibrator Set Hemoglobin A1c Control Set and HSi Hemolysis amp Wash Solution as well as the HLC 723G8 Operator s Manual 1 Press the Stop key on the HLC 723G8 system operation panel to enable the STAND BY state 2 Remove the cap from the elution buffer pack 3 Make sure to insert the tube matching the color of the elution buffer pack being installed 4 Gently squeeze the elution buffer pack by hand to remove all excess air and tighten cap firmly into place to create a vacuum that will prevent air from entering during operation 5 Press the MAINTE key and then the REAGENT CHANGE key 6 Press the keys of the reagents to be replaced on the REAGENT CHANGE screen 7 Press the CHANGE key A confirmation message will be displayed If everything is all right press the OK key 10 Assay Procedures Refer to the HLC 723G8 Operator s Manual for detailed instructions 11 Precautions for Use 1 Carefully read the instructions contained in this IFU and related Instructions For Use provided with HLC 723G8 TSKgel G8 HSi Hemoglobin A1c Calibrator Set Hemoglobin A1c Control Set and HSi Hemolysis amp Wash Solution 2 The G8 Elution Buffer HSi is designed exclusively for use in combination with the HLC 723G8 analyzer system TSKgel G8 HSi and HSi Hemolysis amp Wash Solution indicated below never in any other combination Tosoh Automated Glycohemoglobin Anal
26. r the following agents up to the concentrations indicated in the table Free bilirubin to 0 19 g L Conjugated bilirubin to 0 20 g L Chyle to 2 130 Formazine turbidity Aspirin to 0 50 g L 3 The presence of HbD HbS HbC and HbE interferes with the assay High HbF and specific types of hemoglobin variants may interfere with the assay 4 In the presence of HbE a shoulder or small peak may be observed behind s A peak 5 Low concentrations of hemoglobin may cause the Total Area of the chromatogram to be lt 500 6 A reduced concentration of HbA may be observed in patients due to limited life span of red blood cells interpret clinical results with caution 7 Hemolysis does not interfere with HbA assay results 19 Specimen Collection and Handling A whole blood sample is required for the assay No special preparation is necessary A venous blood sample is collected aseptically The blood samples in primary tubes which contain EDTA NaF Heparin or Citric acid may be stored at 25 C for 24 hours prior to analysis or at 4 C for 14 days TOSOH wm 3 8 2 105 8623 TEL 03 5427 5181 FAX 03 5427 5220 ill TOSOH CORPORATION BIOSCIENCE DIVISION Shiba Koen First Bldg 3 8 2 Shiba Minato ku Tokyo 105 8623 Japan Phone 81 3 5427 5181 Fax 81 3 5427 5220 TOSOH EUROPE N V Transportstraat 4 B 39
27. stics 1 Dilution Linearity The tests were performed with Hemoglobin A1c Control diluted with various percentage factors to determine the effect on the s A 96 value Linearity was observed for the Total Area in the 500 to 2700 range and measurement in the range of 700 to 2500 is recommended to give more reliable results Total Area S Aic 96 324 50 9 4 652 54 9 9 939 78 9 9 1199 05 9 9 1552 53 10 0 1833 12 10 0 2104 36 10 1 2321 57 10 1 2610 74 10 1 2858 85 10 2 2 Recovery The table below shows the recovery ratios for two types of samples mixed in different percentage factors High s Ai Low s Ai Measurement Theoretical Recovery sample sample value value ratio ratio ratio S A 96 S A 96 96 0 10 2 7 1 9 4 7 4 7 100 0 2 8 6 5 6 7 97 0 3 T 8 4 8 5 98 8 4 6 10 2 10 3 99 0 5 5 11 9 12 2 97 5 6 4 13 6 13 9 97 8 7 3 15 3 15 5 98 7 8 2 17 0 17 3 98 3 9 1 18 8 19 0 98 9 10 0 20 1 3 Correlation The correlation between the s A 9e values for the HLC 723G8 and HLC 723G7 analyzers and for the HLC 723G8 and HLC 723GHbV A1c2 2 analyzers are shown in the graph below These methods are certified by National Glycohemoglobin Standardization Program NGSP The correlation between the s A 96 for HLC 723G8 and HLC 723G7 analyzers y 0 989x 0 059 0 999
28. when elution buffer is almost empty Avoid refilling leftover elution buffer into aluminum pack as this can produce unreliable assay results 9 For safe waste disposal it is recommended that each laboratory complies with established laboratory procedures and local state and federal regulations 12 Reference Data from the HLC 723G8 Assay Examples Format 100 Control oo o 2 x aw eon 7 GO Qa NOS ac ciu wo Bie c os c o s eo o lt oQGws o a gt o u e co d 8 So 0 z 8z wonooooox us S n x ZSOQN60TORU s e xc e e o o o o o Z S AES lt m oc oc EI gt lt 0 Za e onomanme e w i Pri ar et tar ar a en ce 5 Once 288 occz 2 a w oo T lt a Svea o sor zat Ico 2 S J o qo o a ic wo SS6n66na5 X T Od fb eon o 9 odoo Sss Y T TNORS u o NO 8 gt Soi 9 z wooooooox ms SS x N 2 e Smo 9 See ces Ei SES 2 9 oc qe E Lj S S48 z Z ossocos lt o Q a E M ooze S
29. yzer HLC 723G8 TSKgel G8 HSi HSi Hemolysis amp Wash Solution L LL 3 Always use the G8 Elution Buffer HSi in combination with the TSKgel G8 HSi of the identical lot number The column lot number is indicated by a single uppercase alphabetical character A B etc on the label of column box The elution buffer label displays an alphabetic character corresponding to the column lot number as shown below Note that the G8 Elution Buffer HSi No 3 is compatible with all lots or vot A column ONT 4 Return the elution buffer to room temperature before use 5 When first opening the aluminum pack to insert the suction tube gently squeeze the elution buffer pack by hand to remove all excess air and tighten bottle cap firmly to create a vacuum that will prevent air from entering during operation 6 Never use reagents that have exceeded the expiration date printed on their labels Assay results for expired reagents will not be reliable Also note that reagents must be used within three months after opening provided that the container is correctly maintained in vacuum state 7 When there is leftover reagent in the aluminum pack that must be removed from the analyzer and stored again gently squeeze the elution buffer pack by hand to remove all excess air and tighten the bottle cap firmly to create a vacuum that will prevent air from entering during storage and store between 4 and 25 C 8 Always replace with an aluminum pack
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