試薬添付文書
Contents
1. B F 4 4 1 2 8C 20 C g 2 3 E TOSOH2. 6 AIA 1200 AIA 600 1 E TOSOH II PRL 2 E TOSOH Il PRL E TOSOH Il PRL 1 E TOSOH II P RL 2 3 E TOSOH II PR LAA RK 4 E TOSOH II SUB II 1 E TOSOH II 4 2 EFA TOSOH Il 5 E TOSOH Il 6 EFA b TOSOH Il PRL 1 1 AIA 1200 AI
3. 8 2 1 EAA HIV HBV HCV 2 3 1 2
4. 15 25 C 30 2 1 2 3 1 E TOSOH U P RL 2 100 w L 30 L 37 C 10 3 B F o 4
5. E TOSOH Il PRL E TOSOH Il PRL E TOSOH TII SUB II E TOSOH I E TOSOH II DYER 7 a 8 HAMA Human Anti mouse Antibody 9 2 G
6. 363 nm 447 nm O O 90 O 6 200 ng mL 1 5 5 AIA 1800 BRPRL 084 Fe arte CalibratoriLot 2003108802070000 Rate 120 100 aot 80 AD 20 0 ph 3 10 20 90 40 50 60 70 80 90 100 110 120 Cone 1 1 E TOSOH II PRL
7. 4 MM ee TRH Thyrotropin Releasing Hormone 1 1 EFA TOSOH II PRL 1 o FU Rate 1 5 nmol L s 2 BE TOSOH TII PRL 1 BE TOSOH II P RL 2 FU FU olk BE 0 4 2 5 nmol L s ng mL FU FU A B C A 2 FU nmol L s B 1 FU nmol L s C 2 ngmL 2 10 175 ng mL 100 20 PRL
8. BE TOSOH II P RL 3 10 175 ng mL 2 10 15 4 1 0 200 ng mL 1 0 ng mL 1 2 1 FU y Wer 2 x SD 10 20 000 ng mL 5 PRL 100 LH 0 03 FSH lt 0 01 TSH lt 0 01 hPL 0 01 hGH 0 04 6 y EIA X DIE LEE Re TOE RUTI y 0 972 x 0 510 r 0 999 n 47 RE BECO AM y x y 0 997 x 0 048 r 0 999 n 197
9. 121 20 3 1 2 8C 2 12 TOSOH Il PRL 100 1 E TOSOH II PRL 1 0 mL x2 2 1 0 mL E TOSOH IE PRL 9013553 RE E TOSOH II 0015968 EFA b TOSOH Il 100 mL x2 E TOSOH IARR 100 mL x24 0015955 E TOSOH Il 100 mL x4 0015956 E TOSOH IL 100 mL x4 1 16 805 807 1988 2 Tyson J E Hwang P Guyda H and Friesen H G Study of prolactin secretion in human pregnancy An J Obstet Gynecol 133 14 30 1972 3 Turkington R W Secretion of prolactin by patient with pituitary and
10. 2 3 134 3 6 16 3 ng mL 24 4 1 28 9 ng mL CLK 2 1 2 SI ng mL S g L gg ng mL x 1 0 PR nr nn ne nn nn nnn nn nn rn re nn rn rn nr rrr rrr rrr csr nn PRL Prolactin 7 23 1977 Shome B Parlow A F 22 000 198
11. 1 1 2 3 90 90 4 5 6
12. rosoH 2 ST AIA PACK PRL Esponelcku norpe nrenu Evrop t z kazn ci Europ iske kunder Europ ische Kunden European customers Evpwraiot neAateg 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 zakaznici Europeiska kunder bg Muctrpykuun 3a ynotpe a Ha pasanuHn esnnu ca Ha pasnono gt kenne Ha Hamma ye6calit www tosohbioscience eu B pasjena Ilomo u n nonapxka Service amp Support Xaprueno KOIIME MOKE fa One nOTyueHo Ha fax 32 13 66 47 49 wm e mail info raqa eu tosoh com Tosun DOIYKT CbIBbpXa MaTepmann YOBelIKM MAN XMUBOTMHCKM NPON3XOA M TPA6Ba Na ObAe TpeTupaH KATO TrOTeHTIMaTHO niekituo3en N vod k pou it v r zn ch jazyc ch je dostupn na na ich webov ch 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 raqa eu tosoh com A Tento v robek obsahuje materi ly poch zej c ze zv at nebo od lid a je t eba s nimi zach zet jako s potenci ln infek n mi Ce hu A Hasznalati utasit s t bb nyelven el rhet websz jtunkon www tosohbioscience eu a Service amp Support Szolg ltat s s Tamogatas szekcio alatt Nyom
13. II PRL 4 390 mg dL 17 mg dL ZT WAM 18 mg dL 1 600 mg dL 5 0 g dL 20 mg dL 100 U mL 5 EDTA 6 2 8 C 15 25 C 1 1 1 EFA TOSOH Il P RL 15 25 C 1 AL 2 SCRE CT 2 E TOSOH II PRL 2 8 C 7 3 E TO
14. hypothalamic tumors J Clin Endocrinol 34 159 164 1972 4 Shome B and Parlow A F Human pituitary prolactin hPRL The entire linear amino acid sequence J Clin Endocrinol Metab 45 1112 1115 1977 5 Antunes J L Housepian E M Franz A G Holub D A Hui R M Carmel P W and Quest D O Prolactin secreting pituitary tumors Ann Neurol 2 148 153 1977 6 Bohnet H G Dahlen H G Wuttke W and Schneider H P G Hyperprolactinemic anovulatory syndrome J Clin Endocrinol Metab 42 132 143 1976 7 Fahie Wilson M N Detection of Macroprolactin Causing Hyperprolactinaemia in Commercial Assays for Prolactin Clin Chem 46 2022 2023 2000 8 Hattori N The Frequency of Macroprolactinemia in Pregnant Women and the Heterogeneity of its Etiologies J Clin Endocrinol Metab 81 586 590 1996 0015355 x2 A 4 0 mL x44 252 1123 2743 1 0120 17 1200 TEL 0467 76 5384 FAX 0467 79 2550 O Tosoh 3 8 2 TEL 03 5427 5181 FAX 03 5427 5220 O
15. 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 ES the assay Heparin up to 100 U mL does not interfere with the assay REFERENCES 1 Frantz A G The Regulation of Prolactin Secretion in Humans In Frontiers in Neuroendocrinology Ganong W F and Martini L ed Oxford Press 1973 2 Frantz A G Physiology in Medicine Prolactin NEJM 198 201 1978 3 Gomez G Reyes F I and Faiman C Non puerperal Galactorrhea and Hyperprolactinemia Am J of Med 62 648 1977 4 Bohnet H G Dahlen H G Wuttke W and Schneider H P G Hyperprolactinemic Anovulatory Syndrome J Clin Endo and Metab 42 132 1975 5 Board J A and Bhatnagar A S Serum Prolactin Levels in Galactorrhea Am J Obstet Gynecol 123 41 1976 6 Martin J B Reichlin S and Brown G M Regulation of Prolactin Secretion and its Disorders In Clinical Neuroendocrinology F A Davis Company Philadelphia 1977 7 Sassin J F Frantz A G Weitzman E D and Rapen S Human Prolactin 24 Hour Pattern With Increased Release Duri
16. comand nd o prin fax la 32 13 66 47 49 sau prin e mail la info raqa eu tosoh com Acest produs contine materiale de provenient uman sau animal si trebuie tratate ca potential infectioase Ve jezicna 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 po ti info raqa eu tosoh com Ta izdelek vsebuje materiale Cloveskega ali zivalskega izvora kar lahko privede do okuzb 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 A See toode sisaldab inim v i loomse paritoluga aineid ning voib olla nakkusohtlik 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 Ce produit contient des substances animales ou humaines et doit par cons quent tre trait comme un produit potentiellement infectieux sk N vod na pou itie vo viacer ch jazykoch je dostupn na na ej web str nke www tosohbioscience eu v
17. 200 and 20 000 ng mL will read gt 200 ng mL The hook effect phenomenon may occur at prolactin concentrations gt 20 000 ng mL 7 TOSOH AIA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST AIA PACK PRL 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 PRL 0025255 AIA PACK PRL CALIBRATOR SET 0020355 AIA PACK PRL SAMPLE DILUTING SOLUTION 0020555 AIA PACK SUBSTRATE SET II 0020968 AIA PACK WASH CONCENTRATE 0020955 ATA PACK DILUENT CONCENTRATE 0020956 1 30 C AIA PACK DETECTOR STANDARDIZATION TEST CUP 0020970 AIA PACK SAMPLE TREATMENT CUP 0020971 ST AIA PACK PRL 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 days 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 Since physical or emotional stress may elevate blood levels of prolactin patients should be under resting b
18. 41 1004171001 099B 2 PRL Immuno Enzymometric Assay a III E TOSOH TPRL ST AIA PACK PRL 2009 4F 9 2 2005 12 1 20100EZZ00112000 1004171001 099B E TOSOH I PRL EIA l PRL 1 2 3 4 HBs HIV HCV 5
19. A 600 10 2 1 EIA IEMA 3 4 5 2 2 EIA IEMA
20. ILUENT CONCENTRATE 0020956 SAMPLE CUPS 0018581 AIA PACK DETECTOR STANDARDIZATION TEST CUP 0020970 AIA PACK SAMPLE TREATMENT CUP 0020971 Additional Requirements for ATA Nex IA AIA 21 only PIPETTE TIPS 0018552 PRELOADED PIPETTE TIPS 0018583 Additional Requirements for AIA 600 II AIA 1800 and AIA 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 Me AND PRECAUTIONS The ST AIA PACK PRL is intended for in vitro diagnostic use only 3 Test cups from different lots or different assays should not be mixed within a tray 3 The STAIA PACK PRL 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 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 PRL has been designed so that the high dose hook effect is not a problem for the vast majority of samples Samples with prolactin concentrations between
21. SOH Il PRL 1 E TTOSOH Il P RL 2 1 0 mL 2 8 C 1 EFA TOSOH U PRL WHO WHO 2nd IS 83 562 4 E TOSOH II 1 E TOSOH U UL 100 mL 15 25 C 3 Hl 2 8 C 7 5 E TOSOH I 1 2 5 L 15 25 C 30 6 E TOSOH USER 1 1 5L
22. and after spiking Sample Initial Prolactin Expected Measured Percent Value Added Value Value Recovery ng mL ng mL ng mL ng mL Serum Al 6 11 40 9 47 0 43 5 92 5 6 11 81 8 87 9 84 4 96 0 6 11 163 6 169 8 169 1 99 6 Serum B1 7 46 40 9 48 4 43 7 90 4 7 46 81 8 89 3 83 7 93 8 7 46 163 6 171 1 170 8 99 8 Serum Cl 3 01 40 9 43 9 40 4 91 9 3 01 81 8 84 8 80 2 94 5 3 01 163 6 166 7 167 0 100 2 b Dilution Three serum samples containing high concentrations of prolactin were serially diluted with AIA PACK PRL SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery ng mL ng mL Serum A2 none 186 2 7 5 10 139 7 131 7 94 3 5 0 10 93 1 83 8 90 0 2 5 10 46 6 40 4 86 8 1 0 10 18 6 16 1 86 6 Serum B2 none 181 5 7 5 10 136 1 126 0 92 6 5 0710 90 7 82 5 90 9 2 5 10 45 4 40 0 88 1 1 0 10 18 1 15 4 84 6 Serum C2 none 156 4 7 5 10 117 3 111 6 95 1 5 0 10 78 2 72 0 92 0 2 5 10 39 1 34 0 87 0 1 0 10 15 6 13 3 85 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 4 32 0 0898 2 1 Serum B3 20 6 0 299 1 5 Serum C3 100 7 1 77 1 8 b Total precision was determined by the
23. anual IN 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 AIA 21 ATA 600 II AIA 1800 AIA 2000 and AIA 360 B Assay Procedure 1 Ensure a sufficient quantity of ST AIA PACK PRL test cups for the number of samples to be run 2 Load patient samples as instructed in the Operator s Manual and proceed with analysis Note The AIA Nex IA AIA 21 AIA 600 II ATA 1800 and AIA 2000 will
24. asal conditions prior to sampling Also prolactin levels rise rapidly with sleep so samples ideally should not be taken until 1 2 hours after awakening Prolactin like other pituitary hormones is secreted episodically it may be advantageous to pool equal volumes of two or more sera from samples drawn at 6 18 minute intervals 12 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 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 ejiles 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 The sample required for analysis is 30 nL PROCEDURE For the AIA Nex IA AIA 21 AIA 600 II AIA 1800 AIA 2000 and AIA 360 please refer to th
25. duplicate assay of three controls 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 4 32 0 126 2 9 Serum B3 20 6 0 580 2 8 Serum C3 100 7 2 72 2 7 CORRELATION The correlation between serum x and heparinized plasma y on ST AIA PACK PRL was carried out using 197 patient specimens Slope 0 997 y Intercept 0 048 Correlation Coefficient 0 999 Range of Samples 2 2 192 5 Number of Samples 197 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as prolactin If these compounds are present in the specimen at the same concentration as prolactin the final result will be increased by these percentages Compound Cross reactivity PRL 100 LH 0 03 FSH lt 0 01 TSH lt 0 01 hPL lt 0 01 hGH 0 04 SENSITIVITY The minimal detectable concentration MDC of prolactin is estimated to be 1 0 ng mL The MDC is defined as the concentration of prolactin which corresponds to the rate of fluorescence that is two standard deviations from the mean rate of fluorescence of 20 replicate determinations of a ZERO CALIBRATOR 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 are
26. eir 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 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 t025L 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 PRL have been standardized on WHO 2nd IS 83 562 1986 The calibration curve for ST AIA PACK PRL 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 probe or detector lamp adjustment or change For further information
27. for diagnosis or therapy may contain human anti mouse antibodies HAMA Such specimens may show falsely elevated values when tested for prolactin e Samples containing macroprolactin may cause falsely elevated results 13 16 Macroprolactin is thought to be a complex of prolactin with human immunoglobulin G hlgG along with possible aggregates of prolactin 14 For a 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 15 Reference Ranges The interval given here was determined in 158 serum samples from apparently healthy Asian individuals Male n 134 Female n 24 3 6 16 3 ng mL 4 1 28 9 ng mL Conversion Factors Prolactin concentrations in this application are in units of ng mL Conversion to SI units of ug L and mIU L may be made using the following equations ng prolactin L ng mLx 1 0 mlU prolactin L ng mL x 27 0 PERFORMANCE CHARACTERISTICS ACCURACY a Recovery Three serum pools were spiked with three different levels of prolactin and assayed before
28. n PRL in human serum or heparinized plasma on TOSOH AIA System Analyzers SUMMARY AND EXPLANATION OF TEST Prolactin PRL is a protein of 198 amino acids with a molecular weight of approximately 21 000 Prolactin is secreted from the anterior pituitary gland and acts directly on the mammary gland to stimulate milk production 1 2 When secreted in excess it increases adrenal androgens and blunts the response of gonadotropes and gonadal cells to tropic factors by decreasing gonadoliberin Thus chronically elevated prolactin induces amenorrhea and infertility in women 3 5 and impotence in men Prolactin synthesis and secretion is under inhibitory control by the hypothalamus The hypothalamic prolactin inhibiting factor PIF is now established as dopamine 1 2 6 Measurement of prolactin concentrations in blood is essential in evaluating patients with infertility or suspected hypothalamic pituitary dysfunction Increased serum prolactin concentrations are observed in pregnancy and during lactation Other conditions associated with abnormal prolactin concentrations have been reported 3 6 7 11 PRINCIPLE OF THE ASSAY The ST AIA PACK PRL is a two site immunoenzymometric assay which is performed entirely in the AIA PACK test cups Prolactin 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 unb
29. n Papierexemplar erhalten Sie auf schriftliche Anfrage an Faxnummer 32 13 66 47 49 oder per E Mail an info raqa eu tosoh com Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle Infektionsquelle behandelt werden Tonodeoia pac www tosohbioscience eu otnv evotnta Service amp Support Mnopeite va AdBete thy vtuny popoh vno aAAovrag aitnon p ow gag otov aptOu 32 13 66 47 49 n p cw nAektpovikod Taxv poueiov info raga eu tosoh com A To npoi v avt mept xet VALKO avOpanivys y Corrs mpo Aevons kat da npene va avr uetwnileta wg SuvyntiKa RoAvoparko a Oa Bpeite Tc Odnyies xpnons oe 7rOAAEc yhoooss ory Staductvakn Lieto anas instrukcijas da d s valod s ir pieejamas m su interneta vietn www tosohbioscience eu sadala 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 is produkts satur cilv ku vai dz vnieku izejmateri lus un ir uzskat ms par potenci li infekciju saturo u Instrukcja Uzytkowania w r znych jezykach jest dostepna na naszej stronie internetowej www tosohbioscience eu w zakfadce 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 Produkt zawiera material pochodzenia ludzkiego lub zwierzecego i dlatego nalezy go t
30. ng Sleep Science 177 1205 1972 8 Noel G L Suh H K and Frantz A G Prolactin Release During Nursing and Breast Stimulation in Postpartum and Nonpostpartum Subjects J Clin Endo and Metab 38 413 1974 9 Turkington R W Underwood L E and Van Wyk J J Elevated Serum Prolactin Levels After Pituitary stalk Section in Man NEJM 285 707 1971 10 Turkington R W Secretion of Prolactin by Patients with Pituitary and Hypothalamic Tumors J Clin Endo 34 159 1972 11 Antunes J L Housepian E M Frantz A G Holub D A Hui R M Carmel P W and Quest D O Prolactin Secreting Pituitary Tumors Ann Neurol 2 148 1977 12 Pesce A J and Raplan L A ed Methods in Clinical Chemistry St Louis C V Mosby Company p 264 1987 13 Fahie Wilson M N Detection of Macroprolactin Causing Hyperprolactinaemia in Commercial Assays for Prolactin Clin Chem 46 2022 2023 2000 14 Hattori N The Frequency of Macroprolactinemia in Pregnant Women and the Heterogeneity of its Etiologies J Clin Endocrinol Metab 81 586 590 1996 15 Young D Effects of Drugs on Clinical Laboratory Tests 3rd Edition Washington DC American Association for Clinical Chemistry Press 1990 16 Beltran L Fahie Wilson M N McKenna T J Kavanagh L and Smith T P Serum Total Prolactin and Monomeric Prolactin Reference Intervals Determined by Precipitation with Polyethylene Glycol Evaluati
31. on and Validation on Common ImmunoAssay Platforms Clin Chem 54 1673 1681 2008 TOSOH CORPORATION 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 EC REP Transportstraat 4 B 3980 Tessenderlo Belgium Phone 32 13 66 88 30 Fax 32 13 66 47 49 E TOSOH BIOSCIENCE INC pplied 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 CK LVD K European Conformity In vitro diagnostic medical device Consult instructions for use Temperature limitation LOT dd Er lS 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
32. ound 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 prolactin concentration in the test sample A standard curve is constructed and unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK PRL Cat No 0025255 Plastic test cups containing lyophilized twelve magnetic beads coated with anti prolactin mouse monoclonal antibody and 100 pL of anti prolactin mouse monoclonal antibody to human prolactin 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 prolactin analysis using the ST AIA PACK PRL Cat No 0025255 on the TOSOH AIA Systems 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 AIA 1800 ST 0019836 AJA 1800 LA 0019837 AIA 2000 ST 0022100 AJA 2000 LA 0022101 AIA 600 I 0019014 AJA 600 IL BCR 0019328 AIA 360 0019945 AIA PACK SUBSTRATE SET II 0020968 AIA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK PRL CALIBRATOR SET 0020355 ZERO CALIBRATOR 0 ng mL POSITIVE CALIBRATOR 100 ng mL approx AIA PACK PRL SAMPLE DILUTING SOLUTION 0020555 AIA PACK WASH CONCENTRATE 0020955 AIA PACK D
33. raktowac jako potencjalnie zaka ny As instrug es de utilizacao encontram se disponiveis em diversos idiomas no nosso sitio www tosohbioscience eu na seccao Service amp Support Servicos e Assist ncia Pode ainda obter uma versao em papel atrav s do fax 32 13 66 47 49 ou do email info raqa eu tosoh com A Este produto cont m materiais de origem humana ou animal e deve ser tratado como potencialmente infeccioso en 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 raqa eu tosoh com IN This product contains human or animal source materials and should be treated as potentially infectious Las instrucciones de uso est n disponibles en diferentes idiomas en nuestra p gina 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 raga eu tosoh com IN Este producto contiene tejidos de origen humano o animal y debe ser tratado como producto potencialmente infeccioso ro Instructiuni de utilizare in diverse limbi sunt disponibile pe site ul nostru www tosohbioscience eu la sectiunea Service amp Support Service si asistent tehnic O versiune pe h rtie poate fi obtinut
34. 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 EPRL 064 Ys Ax B Calibrator Lot 2003106802070000 Rate HA ttt ttt HH D 0 10 20 30 40 50 60 70 80 90 100110 120 Conc 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 ZERO CALIBRATOR for ST AIA PACK PRL is provided ready for use TOSOH recommends that all calibrators be run in triplicate 4 POSITIVE CALIBRATOR for ST AIA PACK PRL is lyophilized It should be reconstituted with 1 0 mL of CAP Class I or NCCLS Type I Reagent Grade water TOSOH recommends that all calibrators be run in triplicate C Calibration Acceptability Criteria 1 The mean rate for the ZERO CALIBRATOR 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 information regarding calibration consult the TOSOH AIA System Operator s M
35. 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 AJA 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 prolactin concentration is found to be greater than the upper limit of the assay range 200 ng mL the specimen should be diluted with the AIA PACK PRL SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 200 ng mL is 1 10 or 1 100 It is desirable to dilute the specimen so that the diluted specimen reads between 5 and 200 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 curves for each analyte at one time Therefore up to two different lots of ST AIA PACK PRL
36. 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 A Tento v robok obsahuje material z udsk ch alebo zvierac ch zdrojov a malo by sa s n m zaobch dza ako s potenci lne infek n m materi lom 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 IN Denna produkt inneh ller material med humant eller animalt ursprung och skall behandlas som potentiellt infekti s 1004171001 099B Rev 09 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 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 PRL For Quantitative Measurement of prolactin PRL in Serum or Heparinized Plasma NAME AND INTENDED USE ST AIA PACK PRL is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of prolacti
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38. 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 041 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 prolactin concentration in ng mL For samples requiring dilution the AIA Nex IA AIA 21 ATA 600 IL 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 maintenance of the wash probe or detector lamp adjustment or change After daily maintenance at least t
39. wo levels of the control should be run in order to verify the overall performance of the TOSOH AIA 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 PRL the highest measurable concentration of prolactin in specimens without dilution is 200 ng mL and the lowest measurable concentration in specimens is 1 0 ng mL assay sensitivity Although the approximate value of the highest calibrator is 100 ng mL the exact concentration may be slightly different 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 spatial interference may occur e Specimens from patients taking medicines and or medical treatment may show erroneous results Specimens from patients who have received preparations of mouse monoclonal antibodies
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