試薬添付文書
Contents
1. 90 90 4 5 6 E2. B FORE 4 4 hGH 1 2 8C 20 C 2 3 E TOSOH I HGH
3. E TOSOH Il HGH ER 2 6 1 0 mL 2 lt BCR 1 E TOSOH I HGH WHO hGH WHO 2nd IS 98 574 E TOSOH II 1 E TOSOH I 1 100 mL 15 25 CC3 2 8 C 7 E TOSOH TI 1 2 5 L 15 25 C 30 E TOSOH II 1 5L
4. 80 73 7 hGH 2 1 ng mL 2 1 2 Si HGH BEZ ng mL 81 a g L u g hGH L ng hGH mL x 1 0 hGH human Growth Hormone 191 2 2 hGH GH GHRH 1 2 HGH GH
5. 15 25 C 30 2 1 2 3 ME 1 2 3 4 5 6 E TOSOH Il HGH 75 L 75 37 C 10 B F
6. AIA 1200 AIA 600 1 E TOSOH II HGH pi HGH HGH 2 E TOSOH II HGH E TOSOH II HGH E TOSOH II HGH E TOSOH Il HGH E TOSOH II HGH E TOSOH II HGH E TOSOH II HGH 3 BEB TOSOH II HGH 4 E TOSOH TI SUB II 1 E TOSOH II 4 2 E TOSOH Ul 5 B TOSOH II 6 B TOSOH II 1 2 3 4 5 6 GH 1 1 1
7. hGH hGH hGH 3 4 1 1 BE TOSOH Il HGH 1 FUL Rate 8 nmol L s 2 E TOSOH II HGH Em 1 BE TOSOH I HGH 6 FU hGH FU okk TE 1 510 nmol L s ng mL 3 E TOSOH II HGH 1 6 FU 1 lt 2 lt 3 lt 4 lt 5 lt 6 FU FU A B C A 6 O FU B Ben 1 FU C 6 hGH nmol L s nmol L s ng mL 2 hGH 2 38 ng mL 100 20 MATT HGH B TO
8. 1 1 0 mL 2 6 SE TOSOH II HGH 0025266 E TOSOH Il HGH BE TOSOH II HGH E TOSOH II E TOSOH I E TOSOH Il 0015955 E TOSOH Il 0015956 E TOSOH II l Raiti S Tolman R A eds Human growth hormone New York Plenum press 1986 2 BHRR 1986 3 Kaplan S A ea Clinical pediatric and adolescent endo crinology Philadelphia WB Saunders Co 1982 4 Irie M et al Increase of serum growth hormone concentration following thyrotropin releasing hormone injection in patients with acromegaly or giantism J Clin Endocrinol Metab 35 97 100 1972 5 Fraiser S in Raiti S ed Growth hormone stimulation tests in children Advances in human growth hormone research Washington D C U S Govt Printing Office 632 652 1973 0015366 SER 1 0 mL x2 0015968 100 mL x2 100 mL x2 252 1123
9. 2743 1 0120 17 1200 TEL 0467 76 5384 FAX 0467 79 2550 TosoH 3 8 2 TEL 03 5427 5181 FAX 03 5427 5220 Oy toso 2 ST AIA PACK HGH C in ee dar tia E a tc O A Haszn lati utas t s t bb nyelven el rhet websz jtunkon a uropmiske kunder Europ ische Kunden www tosohbioscience eu a Service amp Support Szolg ltat s European customers Evpwrtaio neA teg Clientes europeos Euroopa kliendid Consommateurs europ ens Eur pai gyfelek Clienti europei Europos klientai Eiropas klienti Klienci europejscy Clientes europeus Clientii europeni Evropski kupci Eur pski z kaznici Europeiska kunder AN Ez a term k emberi vagy llati forr sanyagokat tartalmaz ez rt lehets gesen fert z k nt kell kezelni 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 Muctrpykunn 3a ynoTpe6a Ha pasnmuHn esuum ca Ha pa3nonoxeHne Ha namna ye ca r www tosohbioscience eu B y Pasmea IIomom u nop oxka Service amp Support Xaprueno Istruzioni per 1 Uso in diverse lingue sono disponibili sul KOTTMe MO
10. 363 nm 447 nm hGH O O 90 45 ng mL 1 5 kk AIA 1800 HGH 029 Calibrator Lot 2003005506070000 Y A Bx x d Rate 250 200 150 160 50 0 9 10 20 30 40 50 Conc 1 1 2 3 E TOSOH II HGH hGH
11. 390 mg dL 17 mg dL ET WAW 18 mg dL 1 600 mg dL 5 0 gl dL 20 mg dL 100 U mL 5 EDTA 6 2 8C 15 25 C 1 1 2 3 4 5 6 E TOSOH II HGH 15 25 C 1 AL 2 SCRE C7 E TOSOH ll HGH 2 8 C 7 E TOSOH II HGH 1
12. TOSOH I HGH E TOSOH U HGH HARE E TOSOH II SUB II E TOSOH I E TOSOH TH 7 hGH HAMA Human Anti mouse Antibody 2 1 HIV HBV HCV
13. AIA 1200 AIA 600 10 2 hGH 1 REIA IEMA 3 hGH DUGH 4 5 2 2 1 EIA IEMA hGH hGH
14. es adequadas Pour les clients en Am rique du Nord et en Am rique du Sud veuillez consulter les documents AIA AAM sur le CD pour P information appropri e ST AIA PACK HGH For Quantitative Measurement of human growth hormone hGH in Serum or Heparinized Plasma NAME AND INTENDED USE ST AIA PACK HGH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of human growth hormone hGH in human serum or heparinized plasma on TOSOH AJA System Analyzers SUMMARY AND EXPLANATION OF TEST Human growth hormone also known as hGH or somatotropin is one of the main hormones produced by the anterior portion of the pituitary gland Unlike most hormones hGH acts to directly stimulate the target cells without the intermediate involvement of a target endocrine organ HGH promotes growth in soft tissue cartilage and bones aids protein synthesis and greatly influences the metabolism of carbohydrates and lipids HGH is a polypeptide made up of 191 amino acids and has a molecular weight of 21 500 daltons The half life of circulating human growth hormone is relatively short 20 30 minutes The release of hGH from the pituitary is influenced by a variety of factors including chemical stimuli and the balance between growth hormone releasing factor GHRF and somatostatin growth hormone release inhibiting hormone 1 2 Sleep stress exercise fasting high protein meals hypoglycemia and certain amino acids such as L dopa g
15. 2 3 1 2 121 C 20 3 1 2 8 C 2 127A 100
16. rekvireres pr fax 32 13 66 47 49 eller e mail info raqa eu tosoh com Lieto anas instrukcijas dazadas valod s ir pieejamas m su interneta vietn www tosohbioscience eu sada Service amp Support Apkalpo ana un Atbalsts Druk tu versiju iesp jams sa emt pa faksu 32 13 66 47 49 vai e pastu A Dette produkt indeholder menneskelige eller animalske tered acne tenon coy udgangsmaterialer og bor behandles som potentielt infektigst IN Sis produkts satur cilv ku vai dzivnieku izejmateri lus un ir uzskat ms par potenciali infekciju saturosu ES Bedienungsanleitungen in verschiedenen Sprachen sind anf 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 Instrukcja U ytkowania w r nych j zykach jest dost pna na naszej stronie internetowej www tosohbioscience eu w zak adce Service amp Support Serwis i Wsparcie O wersje papierow mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem info raqa eu tosoh com Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle y Produkt zawiera materia pochodzenia ludzkiego lub Infektionsquelle behandelt werden zwierz cego i dlatego nale y go traktowa jako potencjalnie sii zaka ny Oa Bpgtr tig O nyieg x
17. since human specimens will be used for samples and other quality control products in the lab may be derived from human serum please use standard laboratory safety procedures in handling all specimens and controls 5 Do not use beyond the expiration date 6 The ST AIA PACK HGH has been designed so that the high dose hook effect is not a problem for the vast majority of samples Samples with hGH concentrations between 45 and 1 100 ng mL will read gt 45 ng mL The hook effect phenomenon may occur at hGH concentrations gt 1 100 ng mL 7 TOSOH AIA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST AIA PACK HGH assay STORAGE AND STABILITY All unopened materials are stable until the expiration date on the label when stored at the specified temperature Materials Cat No 2 8 C ST AIA PACK HGH 0025266 AIA PACK HGH CALIBRATOR SET 0020366 AfA PACK HGH SAMPLE DILUTING SOLUTION 0020566 AIA PACK SUBSTRATE SET I 0020968 AIA PACK WASH CONCENTRATE 0020955 AIA PACK DILUENT CONCENTRATE 0020956 1 30 C AIA PACK DETECTOR STANDARDIZATION TEST CUP 0020970 AIA PACK SAMPLE TREATMENT CUP 0020971 ST AIA PACK HGH test cups may be stored at 18 25 C for up to 1 day Calibrators and Sample Diluting Solution should be used within 1 day and 7 days of opening or reconstituting respectively provided the vials are kept tightly sealed and refrigerated at 2 8 C Reconstituted substrate solution is stable for 3 d
18. spatial interference may occur Specimens from patients taking medicines and or medical treatment may show erroneous results e Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti mouse antibodies HAMA Such specimens may show falsely elevated values when tested for human growth hormone e For more complete understanding of the limitations of this procedure please refer to the SPECIMEN COLLECTION AND HANDLING WARNINGS AND PRECAUTIONS STORAGE AND STABILITY and PROCEDURAL NOTES sections in this insert sheet EXPECTED VALUES Each laboratory should determine a reference interval which corresponds to the characteristics of the population being tested As with all diagnostic procedures clinical results must be interpreted with regard to concomitant medications administered to the patient 6 Reference Ranges The reference value less than 2 1 ng mL was determined by applying parametric analysis to serum samples from 80 healthy Asian individuals 73 males and 7 females Conversion Factors HGH concentrations in this application are in units of ng mL Conversion to SI units of ug L and mIU mL may be made using the following equation ng hGH L nghGH mLx 1 0 mIU hGH mL ng hGH mL x30 PERFORMANCE CHARACTERISTICS ACCURACY a Recovery Three serum pools were spiked with three different levels of hGH and assayed before and after spiking Sample In
19. which is performed entirely in the AIA PACK test cups Growth hormone present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme labeled monoclonal antibody in the AIA PACK test cups The magnetic beads are washed to remove unbound enzyme labeled monoclonal antibody and are then incubated with a fluorogenic substrate 4 methylumbelliferyl phosphate 4MUP The amount of enzyme labeled monoclonal antibody that binds to the beads is directly proportional to the hGH concentration in the test sample A standard curve is constructed and unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AiA PACK HGH Cat No 0025266 Plastic test cups containing lyophilized twelve magnetic beads coated with anti HGH mouse monoclonal antibody and 75 pL of anti HGH mouse monoclonal antibody to human growth hormone conjugated to bovine alkaline phosphatase with sodium azide as a preservative MATERIALS REQUIRED BUT NOT PROVIDED The following materials are not provided but are required to perform human growth hormone analysis using the ST AIA PACK HGH Cat No 0025266 on the TOSOH AIA System Analyzers They are available separately from TOSOH Materials Cat No AIA Nex IA or AIA 21 0018539 AIA Nex IA or AIA 21 LA 0018540 AJA 1800 ST 0019836 AIA 1800 LA 0019837 AIA 2000 ST 0022100 ATA 2000 LA 0022101 AIA 600 II 0019014 AIA 600 II BCR 0019328 AIA 360 0019945 AIA PACK SUBST
20. 1006671001 059C 3 HGH Immuno Enzymometric Assay E TOSOH II HGH ST AIA PACK HGH 4 1006671001 059C 20094 5 3 2006 10 2 13A2X00174000013 OE TOSOH I HGH EIA GH 1 2 3 4 HBs HIV HCV 5 6
21. KE la 0 nonyueno Ha fax 32 13 66 47 49 wm e mail nostro sito web www tosohbioscience eu alla sezione Service info raga eu tosoh com amp Support Versione cartacea pu essere richiesta via fax al 32 13 66 47 49 o via e mail a info raqa eu tosoh com Tosu nponyKT Cb bpxKa MaTepuanu C YOBeLIKM MIN XMUBOTUHCKM IPONSXON M TpA BA Ja Ope TpeTUpaH KATO A Il prodotto contiene materiali di origine umana o animale NOTCHIMAHO UHPEKIMOSEH e va trattato come potenzialmente infettivo n vod k pou it v r zn ch jazyc ch je dostupn na na ich Fit Taran DEREN y See webovYch strankach www tosohbioscience eu v sekci Service Naudojimo instrukcijas vairiomis kalbomis galite rasti m s amp Support Ti t nou verzi m ete obdr et faxem slo 32 tinklalapio www tosohbioscience eu skyriuje Service amp 13 66 47 49 nebo e mailem info raqa eu tosoh com Support Popierine versij galite gauti faksu 32 13 66 47 49 arba el pa tu info raqa eu tosoh com A Tento vyrobek obsahuje materi ly pochazejici ze zvirat DER 3 a a si nebo od lid a je tfeba s nimi zach zet jako s potenci ln A Siame gaminyje yra mogaus arba gyv n kilm s med iag infek n mi tad elkit s taip tarsi jie gal t sukelti infekcij En Flersprogede brugsanvisninger findes p vores hjemmeside www tosohbioscience eu under Service amp Support sektionen Trykte brugsanvisninger kan
22. RATE SET II 0020968 AIA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK HGH CALIBRATOR SET 0020366 CALIBRATOR 1 0 ng mL CALIBRATOR 2 1 9 ng mL approx CALIBRATOR 3 3 8 ng mL approx CALIBRATOR 4 11 3 ng mL approx CALIBRATOR 5 22 6 ng mL approx CALIBRATOR 6 49 1 ng mL approx ATA PACK HGH SAMPLE DILUTING SOLUTION 0020566 AJA PACK WASH CONCENTRATE 0020955 AIA PACK DILUENT CONCENTRATE 0020956 SAMPLE CUPS 0018581 AIA PACK DETECTOR STANDARDIZATION TEST CUP 0020970 AIA PACK SAMPLE TREATMENT CUP 0020971 Additional Requirements for AIA Nex IA AIA 21 only PIPETTE TIPS 0018552 PRELOADED PIPETTE TIPS 0018583 Additional Requirements for AIA 600 II AIA 1800 and ATA 2000 PIPETTE TIPS 0019215 TIP RACK 0019216 PRELOADED PIPETTE TIPS 0022103 Only materials obtained from TOSOH should be used Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on TOSOH materials WARNINGS AND PRECAUTIONS 1 The ST AIA PACK HGH is intended for in vitro diagnostic use only 2 Test cups from different lots or different assays should not be mixed within a tray 3 The ST AIA PACK HGH contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides When disposing of such reagents always flush with large volumes of water to prevent azide build up 4 Human serum is not used in the preparation of this product however
23. SOH II HGH 3 hGH 2 38 ng mL 2 10 15 4 0 07 45 ng mL 0 07 ng mL 1 6 L BRE 1 FU y WH 2 x SD 10 1 100 ng mL x 8 5 hGH 100 Prolactin 0 335 hPL 0 005 TSH N D LH N D FSH N D hCG 0 002 N D 6 ASE y EIA x 3 y 0 938 x 0 042 r 0 999 n 50 BB ARCOS Vv mgt y x y 0 963 x 0 018 r 0 999 n 116 1 1
24. ated as potentially infectious Acest produs con ine materiale de provenien uman sau animal si trebuie tratate ca potential infec ioase Las instrucciones de uso estan disponibles en diferentes Sa E Bu idiomas en nuestra pagina web www tosohbioscience eu en la Vecjezicna navodila za uporabo so na voljo na nasi spletni secci n de Service amp Support Servicio y Soporte Tambi n strani www tosohbioscience eu v razdelku Service amp podemos enviarle una versi n impresa a trav s del fax 32 13 Support Servis in podpora V papirni obliki jih lahko 66 47 49 o por correo electr nico info raga eu tosoh com prejmete po faksu 32 13 66 47 49 ali elektronski po ti info raqa eu tosoh com A Este producto contiene tejidos de origen humano o animal y debe ser tratado como producto potencialmente infeccioso Penzdcle vsebuje materiale cloveskeea all Zivalakesa izvora kar lahko privede do okuzb L E3 N vod na pou itie vo viacer ch jazykoch je dostupn na na ej web str nke www tosohbioscience eu v sekcii Service amp Support Vytla en verziu mo no z ska faxom 32 13 66 47 49 alebo cez e mail info raqa eu tosoh com 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 g
25. ays at 18 25 C or 7 days at 2 8 C Working diluent and wash solutions are stable for 30 days at 18 25 C Reagents should not be used if they appear cloudy or discolored SPECIMEN COLLECTION AND HANDLING Serum or heparinized plasma is required for the assay EDTA and citrated plasma SHOULD NOT BE USED If using serum a venous blood sample is collected aseptically without additives Store at 18 25 C until a clot has formed usually 15 45 minutes then centrifuge to obtain the serum specimen for assay If using heparinized plasma a venous blood sample is collected aseptically with designated additive Centrifuge and separate plasma from the packed cells as soon as possible e Specimen types should not be used interchangeably during serial monitoring of an individual patient Measured concentrations may vary slightly between sample types in certain patients Samples may be stored at 2 8 C for up to 24 hours prior to analysis If the analysis cannot be done within 24 hours the sample should be stored frozen at 20 C or below for up to 60 days Repeated freeze thaw cycles should be avoided Turbid serum samples or samples containing particulate matter should be centrifuged prior to testing Prior to assay bring frozen samples to 18 25 C slowly and mix gently Diluted serum or heparinized plasma should be used within 24 hours and should not be stored The sample required for analysis is 75 pL PROCEDURE For the AJA N
26. e added to human specimens Hemoglobin up to 390 mg dL free bilirubin up to 17 mg dL and conjugated bilirubin up to 18 mg dL do not interfere with the assay Lipemia as indicated by triglyceride concentration up to 1 600 mg dL does not interfere with the assay Ascorbic acid up to 20 mg dL does not interfere with the assay e Protein as indicated by human albumin concentration up to 5 0 g dL does not interfere with the assay Heparin up to 100 U mL does not interfere with the assay REFERENCES 1 Raiti S Tolman R A eds Human Growth Hormone New York Plenum Press 1986 2 Fujita T et al Essentials of Endocrinology and Metabolism Tokyo Medical Press 34 77 1986 3 Kaplan S A ea Clinical Pediatric and Adolescent Endocrinology Philadelphia W B Saunders Co 1982 4 Irie M et al Increase of Serum Growth Hormone Concentration Following Thyrotropin Releasing Hormone Injection in Patients with Acromegaly or Giantism J Clin Endocrinol Metab 35 97 100 1972 5 Frasier S in Raiti S ed Growth Hormone Stimulation Tests in Children Advances in human growth hormone research Washington D C U S Govt Printing Office 632 652 1973 6 Young D Effects of Drugs on Clinical Laboratory Tests 3rd Edition Washington DC American Association for Clinical Chemistry Press 1990 TOSOH CORPORATION Shiba koen First Bldg 3 8 2 Shiba Minato ku Tokyo 105 8623 Ja
27. ex IA AIA 21 AIA 600 II AIA 1800 AIA 2000 and AIA 360 please refer to their Operator s Manual for detailed instructions Reagent Preparation A Substrate Solution Bring all reagents to 18 25 C before preparing the working reagent Add the entire contents of the AIA PACK SUBSTRATE RECONSTITUENT II 100 mL to the lyophilized AIA PACK SUBSTRATE REAGENT I and mix thoroughly to dissolve the solid material B Wash Solution Add the entire contents of the AIA PACK WASH CONCENTRATE 100 mL to approximately 2 0 L of CAP Class I or NCCLS Type I Reagent Grade water mix well and adjust the final volume to 2 5 L C Diluent Add the entire contents of the AIA PACK DILUENT CONCENTRATE 100 mL to approximately 4 0 L of CAP Class I or NCCLS Type I Reagent Grade water mix well and adjust the final volume to 5 0 L ll Calibration Procedure A Calibration Curve The calibrators for use with the ST AIA PACK HGH have been standardized on WHO 2nd IS 98 574 The calibration curve for ST AIA PACK HGH is stable for up to 90 days Calibration stability is monitored by quality control performance and is dependent on proper reagent handling and TOSOH AIA System maintenance according to the manufacturer s instructions Recalibration may be necessary more frequently if controls are out of the established range for this assay or when certain service procedures are performed e g temperature adjustment sampling mechanism changes maintenance of the wash
28. itial hGH Expected Measured Percent Value Added Value Value Recovery ng mL ng mL name ng mL Serum Al 0 08 32 15 2 23 30 50 94 6 0 08 16 07 len 15 28 946 0 08 8 04 8 12 773 95 2 Serum Bl 0 23 32 15 32 38 30 27 93 5 0 23 16 07 16 31 14 94 91 6 0 23 8 04 8 27 7 73 93 5 Serum Cl 1 65 32 15 33 79 34 56 102 3 1 65 16 07 17 72 18 18 102 6 1 65 8 04 9 68 10 19 105 3 b Dilution Three serum samples containing high concentrations of hGH were serially diluted with AIA PACK HGH SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery ng mL ng mL Serum A2 none 41 20 75 10 30 90 31 55 102 1 5 0 10 20 60 21 56 104 6 2 5 10 10 30 10 90 105 8 10 10 4 12 4 47 108 6 Serum B2 none 40 22 75 10 30 16 29 55 98 0 5 0 10 20 11 19 88 98 9 2 5 10 10 05 10 04 99 8 1 0 10 4 02 4 04 100 4 Serum C2 none 39 26 75 10 29 44 29 74 101 0 5 0 10 19 63 20 27 103 3 2 5 10 9 81 10 24 104 3 1 0 10 3 93 4 13 105 3 PRECISION a Within run precision was determined using three controls in a total of 20 runs Within each run one set of duplicates per control was assayed The mean of each duplicate was used to obtain the pooled standard deviation SD which was then used to calculate the coefficient of variation CV Sample Mean Pooled SD CV ng mL ng mL Serum A3 2 60 0 048 19 Serum B3 7 87 0 100 13 Serum C3 25 3 0 227 0 9 b Total precision was determined by the duplicate assay of three c
29. lucagon arginine and histamine all cause increases in hGH secretion HGH release is inhibited by glucose cortisol free fatty acids and circulating hGH g The effect of hypersecretion of growth hormone depends on the age of the patient Acromegaly a progressive enlargement of the extremities is caused by excess hGH in adults In children hypersecretion causes the phenomenon of accelerated growth with weakened bones and muscles termed gigantism Hypersecretion can be caused by pituitary hyperplasia or tumors or by secondary factors such as a lack of release inhibiting factors or ectopic production of hGH by certain types of carcinoma 3 5 Hyposecretion of hGH may be caused by lesions within the hypothalamus an increase in the production of somatostatin a lack of growth hormone releasing factor pituitary tumors which destroy the cells producing hGH or even damage to the pituitary by external factors such as trauma or infection Children deficient in hGH are said to have a condition known as pituitary dwarfism Random growth hormone measurement is not usually meaningful Screening tests for hGH deficiency hGH hypersecretion and assessment of pituitary hypothalamic function utilize a variety of provocative tests challenge tests In this type of testing serial blood samples are drawn and hGH response is measured against criteria for the specific testing protocol PRINCIPLE OF THE ASSAY The ST AIA PACK HGH is a two site immunoenzymometric assay
30. nce of the wash probe or detector lamp adjustment or change After daily maintenance at least two levels of the control should be run in order to verify the overall performance of the TOSOH AJA System Analyzers 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 with the strict regulatory agency under which the laboratory operates LIMITATIONS OF THE PROCEDURE For diagnostic purposes the results obtained from this assay should be used in conjunction with other data e g symptoms results of other tests clinical impressions therapy etc Using ST AIA PACK HGH the highest measurable concentration of human growth hormone in specimens without dilution is 45 ng mL and the lowest measurable concentration in specimens is 0 07 ng mL assay sensitivity Although the approximate value of the highest calibrator is 49 7 ng mL the exact concentration may be slightly different The assay specification ASSAY RANGE HIGH should be defined as the upper limit of the assay range 45 ng mL Although hemolysis has an insignificant effect on the assay hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution Lipemia has an insignificant effect on the assay except in the case of gross lipemia where
31. ontrols in 20 separate runs The means of each run were used to calculate the pooled standard deviation SD and coefficient of variation CV Sample Mean Pooled SD CV ng mL ng mL Serum A3 2 60 0 105 40 Serum B3 787 0 262 33 Serum C3 25 3 0 695 2 7 CORRELATION The correlation between serum x and heparinized plasma y on ST AIA PACK HGH was carried out using 116 patient specimens Slope 0 963 y Intercept 0 018 Correlation Coefficient 0 999 Range of Samples 0 07 45 17 Number of Samples 116 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as hGH If these compounds are present in the specimen at the same concentration as hGH the final result will be increased by these percentages Compound Cross reactivity hGH 100 Prolactin 0 335 hPL 0 005 TSH N D LH N D FSH N D hCG 0 002 N D not detectable SENSITIVITY The minimal detectable concentration MDC of human growth hormone is estimated to be 0 07 ng mL The MDC is defined as the concentration of hGH which corresponds to the rate of fluorescence that is two standard deviations from the mean rate of fluorescence of 20 replicate determinations of a CALIBRATOR 1 INTERFERENCE Interference is defined for the purposes of this study as recovery outside of 10 of the known mean concentration of the specimen after the following substances ar
32. ormation regarding calibration consult the TOSOH AIA System Operator s Manual Ill Quality Control Procedure A Commercially Available Controls Commercially available controls should be run at least once per day It is recommended that at least two levels of controls normal and abnormal be used Laboratory policy for this particular assay designates the following Control Material Frequency Lot number of control material acceptable limits and corrective action to be taken if controls do not meet laboratory criteria will be found in a separate quality control document maintained by the laboratory B Quality Control Procedure 1 Assay quality control specimens as instructed in the specific Operator s Manual for your analyzer In addition refer to the TOSOH AIA System Operator s Manual for detailed instructions on defining and editing the files 2 Quality control material to be run with this assay is defined by individual laboratory policy IV Specimen Processing A Preparation Following specific instructions in the Operator s Manual for the analyzer place samples on the instrument appropriately Barcoded primary tubes as well as sample cups can be run on the AIA Nex IA ATA 21 AIA 600 II AIA 1800 ALA 2000 and AIA 360 B Assay Procedure 1 Ensure a sufficient quantity of ST AIA PACK HGH test cups for the number of samples to be run 2 Load patient samples as instructed in the Operator s Manual and proceed with anal
33. pan Phone 81 3 5427 5181 Fax 81 3 5427 5220 TOSOH EUROPE N V IEC REP Transportstraat 4 B 3980 Tessenderlo Belgium Phone 32 13 66 88 30 Fax 32 13 66 47 49 TOSOH BIOSCIENCE INC Supplied by 6000 Shoreline Ct Suite 101 South San Francisco CA94080 USA Phone 1 650 615 4970 Fax 1 650 615 0415 Phone 800 248 6764 Fax 800 685 7595 CC VD 5 Xx European Conformity In vitro diagnostic medical device Consult instructions for use Temperature limitation LOT MM ER gg Authorized representative in the European Community Supplied by N Catalogue number Supplied by Sufficient for Part number Batch code Lot number Manufacturer Use by date
34. pnons oe 7OAAEc yAwoasg otn Sradectvaki Tonodeoia nac www tosohbioscience eu otnv ev tnta Service amp Support Mnopeite va Berg tnv vrurn popoh vroB llovras As instru es de utiliza o encontram se dispon veis em diversos idiomas no nosso sitio www tosohbioscience eu na aitnon p co gag otrov apt u 32 13 66 47 49 Eoo sec o Service amp Support Servi os e Assist ncia Pode ainda NAEKTPOVIKOD Taxv poueiov info raqa eu tosoh com obter uma vers o em papel atrav s do fax 32 13 66 47 49 ou A i i A do email info raqa eu tosoh com To npo v avt replEXEL vA k avOpwrnivys A Cwucis rpo levons kat da npenei va avtipetwmivetat w vvn tia A Este produto cont m materiais de origem humana ou OADOLCt UKO animal e deve ser tratado como potencialmente infeccioso Instructions For Use in multiple languages are available on our ro Instructiuni de utilizare in diverse limbi sunt disponibile pe website www tosohbioscience eu under the Service site ul nostru www tosohbioscience eu la sectiunea Service Support section A paper version can be obtained by fax 32 amp Support Service si asistent tehnic O versiune pe h rtie 13 66 47 49 or e mail info raqa eu tosoh com poate fi obtinut comand nd o prin fax la 32 13 66 47 49 sau prin e mail la info raqa eu tosoh com IN This product contains human or animal source materials i ae gt and should be tre
35. probe or detector lamp adjustment or change For further information regarding instrument operation consult the TOSOH AIA System Operator s Manual A sample calibration curve from AIA 1800 follows and shows the algorithm used for calculating results RHGH 029 Calibrator Lot 2003005506070000 Fe Ag B r D Rate 250 200 150 100 50 0 9 10 20 30 40 50 Cone B Calibration Procedure 1 Refer to the appropriate TOSOH AIA System Operator s Manual for the procedural instructions 2 Verify that both the calibrator lot and concentration numbers have been correctly entered into the software 3 CALIBRATOR 1 for ST AIA PACK HGH is provided ready for use TOSOH recommends that all calibrators should be run in triplicate 4 CALIBRATOR 2 6 for ST AIA PACK HGH are lyophilized All levels should be reconstituted with 1 0 mL of CAP Class I or NCCLS Type I Reagent Grade water TOSOH recommends that all calibrators should be run in triplicate C Calibration Acceptability Criteria 1 The mean rate for the CALIBRATOR 1 should be lt 3 0 nmol L s 2 Since there is a direct relationship between concentration and rate the rate should increase as the concentration increases 3 The replicate values should be within a 10 range D Calibration Review and Acceptance 1 Review the calibration curve carefully using the criteria listed above 2 Edit the calibration if necessary then accept the calibration For further inf
36. s for each analyte at one time Therefore up to two different lots of ST AIA PACK HGH test cups can be used during the same run 5 If the assay specifications for this test are not ready in the system software the specifications must be entered under test code 066 CALCULATION OF RESULTS The TOSOH AIA System Analyzers perform all sample and reagent handling operations automatically The TOSOH AIA System Analyzers read the rate of fluorescence produced by the reaction and automatically convert the rate to human growth hormone concentration in ng mL For samples requiring dilution the AIA Nex IA AJA 21 AIA 600 II AIA 1800 and AIA 2000 will automatically perform dilutions and calculate results if the dilution factors are entered into the software Dilution factors may be entered into the Test File or pre defined dilution factors may be selected in Specimen Processing EVALUATION OF RESULTS Quality Control In order to monitor and evaluate the precision of the analytical performance it is recommended that commercially available control samples should be assayed according to the local regulations The minimum recommendations for the frequency of running internal control material are After calibration three levels of the internal control are run in order to accept the calibration curve The three levels of controls are repeated when certain service procedures are performed e g temperature adjustment sampling mechanism changes maintena
37. t See toode sisaldab inim v i loomse p ritoluga aineid ning IN Tento v robok obsahuje material z udsk ch alebo zvierac ch v ib olla nakkusohtlik zdrojov a malo by sa s n m zaobch dza ako s potenci lne infek n m materi lom Les instructions d utilisation sont disponibles en plusieurs langues sur notre site web www tosohbioscience eu dans la rubrique Service amp Support Vous pouvez obtenir un exemplaire papier par fax au n 32 13 66 47 49 ou par e mail P adresse info raqa eu tosoh com 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 Ce produit contient des substances animales ou humaines et doit par cons quent tre trait comme un produit potentiellement infectieux A Denna produkt inneh ller material med humant eller animalt ursprung och skall behandlas som potentiellt infekti s 1006671001 059C Rev 05 09 Attention For North and South American Customers Please refer to the AIA AAM Docs on CD for the appropriate information Para los Clientes en Norte y Sur Am rica favor de referirse a los documentos AIA AAM en Disco para la informaci n apropiada Aos clientes da Am rica do Norte e Am rica do Sul favor consultar os documentos do AIA AAM que est o em CD para informa
38. ysis Note The AIA Nex IA AIA 21 AIA 600 II AIA 1800 and AIA 2000 will require AIA PACK SAMPLE TREATMENT CUPs if onboard dilutions are utilized PROCEDURAL NOTES 1 Lyophilized substrate must be completely dissolved 2 Ligand assays performed by the TOSOH AIA System Analyzers require that the laboratory use water designated by the College of American Pathologists as Class I or by NCCLS as Type I Water should be tested at least once per month and should be free of particulate matter including bacteria The pH of the water should also be routinely tested For further information consult the NCCLS document Preparation and Testing of Reagent Water in the Clinical Laboratory NCCLS Document C3 A3 Volume 11 No 13 originally approved as a guideline by NCCLS in October 1997 3 If a specimen human growth hormone concentration is found to be greater than the upper limit of the assay range 45 ng mL the specimen should be diluted with the AIA PACK HGH SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 45 ng mL is 1 10 or 1 100 It is desirable to dilute the specimen so that the diluted specimen reads between 0 07 and 45 ng mL The dilution factor should be entered into the software For further information on the dilution of specimens refer to the TOSOH AIA System Operator s Manual 4 The TOSOH AIA System Analyzers can store two different calibration curve
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