FREND Testosterone_Package insert (v.0.0)
Contents
1. outlined in CLSI document EP09 A2 IR Samples n 120 were measured in duplicate on both systems Linear regression analysis was utilized to demonstrate a slope that 1 0 0 2 and a correlation coefficient R of gt 0 92 14 000 y 0978x 0 0868 R 09591 es ee 0 000 2000 4000 6000 8000 10 000 12 000 14000 16 000 Predicate devices A ng mL Specificity FREND Testosterone demonstrates cross reactivity with the following related substances at the concentrations indicated bellows CLS document EP7 A2 was used to analyze and calculate cross reactivity using serum samples at three levels of Testosterone within the normal range Testosterone concentration level Substance Concentration Low Median High Cross reactivity 17 a ethynylestradiol 100 ng mL 99 8 97 0 98 5 17 a hydroxyprogesterone 100 ng mL 106 8 103 9 96 0 19 Norethinrone 100 ng mL 101 5 93 2 102 7 19 Norethindrone acetate 100 ng mL 94 4 93 1 93 4 Cholramphenicol4 Androsen 3 17 dione 10 00 ng mL 108 5 993 98 4 Androstenedione 5 a DHT 50 ng mL 97 0 100 3 105 7 Androsterone 50 000 ng mL 100 9 106 1 105 5 Corticosterone 5 000 ng mL 105 0 99 8 101 8 Cortisone 1 000 ng mL 99 8 96 9 103 5 Danazol 1 000 ng mL 105 6 105 8 96 9 Estradiol 1 000 ng mL 89 1 98 9 96 7 Estriol 100 ng mL 93 9 98 6 97 4 Estrone 500 ng mL 94 7 95 4 106 1 Norgestrel 100 ng mL 90 4 94 1 105 8 Progesterone 1 000 ng mL 97 2 98 2 95 1 Reichstein s substance S 11 Deo2. in licensed clinical laboratories with trained technologies Performance characteristics Performance characteristics were evaluated for the FREND Testosterone as follows 11 Precision Clinical and Laboratory Standards Institute CLSI document EP5 A2 was utilized as a guidance for precision studies on FREND Testosterone Three human serum based panels were assayed in two replicates twice per day over a period of 20 days sample Mean Within run Between run Between day Within laboratory D rg ml so cv so c so so ov 1 1 56 0 128 8 2 0 047 3 1 0 010 0 6 0 137 8 8 2 5 98 0 313 5 2 0 054 0 9 0 135 23 0 345 58 3 12 04 0 609 5 1 0 239 2 0 0 094 0 8 0 660 5 5 Dilution linearity The range of linearity in serum was established using CLSI document EP6 A FREND Testosterone was found to have linearity within the reportable range of 0 20 ng mL 15 00 ng mL with a mean recovery of 100 10 The dilution linearity study was performed by diluting a high concentration Testosterone specimen with a low concentration Testosterone specimen Results are summarized in the graphs below but may vary in individual laboratories an aos 00779 1600 per lt J uo A gt on f 1000 fo a g ee x a0 E ra j w y o K aw m oo o ao Expected value ngit Comparative analysis FREND Testosterone was compared to the predicate device using guidelines
3. NESPI FRTE 001EN V 0 0 Nano ntTek CE FREND Testosterone Total Testosterone Intended use The FREND Testosterone test is a fluorescent nanoparticle immunoassay designed for in vitro quantitative measurement of total testosterone in human serum and plasma EDTA and Lithium heparin The FREND Testosterone microfluidic flow cartridge is designed for use in the FREND System fluorescent immunoassay reader Summary and explanation of test Testosterone is a male sex hormone secreted by Leydig or interstitial cells of the testes Testosterone levels are controlled by luteinizing hormone secreted by the pituitary gland via negative feedback on the pituitary gland and hypothalamus Serum concentrations of testosterone sequentially rise and fall through the fetal stage until 6 months after delivery due to maternal hormonal changes and then remain low e g 0 3 ng mL between six months of age and puberty After puberty the increase of testosterone levels in males is gradual until it reaches adult level Table 1 In females testosterone is produced mainly by conversion of prehormones Table 1 Typical Physiological Testosterone Level Male ng mL Female ng mL Prepubertal 0 01 1 77 0 01 0 20 Pubertal 0 02 8 00 0 02 0 40 Adult 2 80 11 00 0 15 0 70 1 Circulating testosterone is 98 protein bound in males with slightly less being bound in females The proteins responsible for binding test
4. ce Heating block provided with FREND System should be turned on 7 8 minutes before use If using refrigerated patient samples remove those from the refrigerator and allow to them to come to room temperature prior to testing If frozen samples will be utilized be sure these are removed from the freezer thawed naturally and then mixed gently but thoroughly prior to testing Testing should not begin on these previously frozen samples until they have reached room temperature There are no other reagents or sample preparations necessary Assay procedure 1 Prepare the FREND Testosterone cartridge pretreatment tube and specimen Open the pouch and place the FREND Testosterone cartridge on the heating block at 37 2 Transfer 70 uL of specimen to the pretreatment tube and mix well Caution Pellet in the tube bottom should be completely dissolved 3 Put the tube in the hole of heating block and incubate for 5 minutes at 37 C 4 Pipette 35 uL of the incubated sample into the sample inlet on the cartridge using a suitable micro pipette equipped with a fresh pipette tip 5 Press the Test button on the Main screen of the FREND System 6 The system moves to the Patient ID screen automatically 7 Type the Patient ID and press the Enter button to begin the test 8 Insert the cartridge into the cartridge slot using the cartridge arrow as a guide A Caution Please check the direction of the cartridge b
5. ce of the system 5 Whenever required by your laboratory s quality control requirements Internal procedural controls FREND Testosterone test cartridge contains built in control feature Fluorescence signal in the reference zone of each cartridge shows 1 that enough volume is added 2 that proper flow is obtained and 3 that the antibody is reactive If this reference zone signal is missing or lower than threshold the FREND System consider it as an incorrect or failed test not producing a test result but an error message In addition with each cartridge run the system monitors in part for 1 flow of sample 2 speed of sample flow 3 shelf life of cartridge components 4 function of internal barcode scanner and 5 function of scanner s mechanical components External quality control testing Commercially available controls from a variety of manufacturers are available that contain 25 hydroxy Testosterone as a measured analyte It is recommended that a minimum of two 2 levels of controls be run at least once per month or once for each new lot whichever comes earlier However Controls should be run with a minimum frequency depending on number of tests run in the laboratory Each laboratory should establish its own criteria based on the following parameters 1 Each new lot 2 Each new shipment even if from the same lot previously received 3 Each new operator an individual who has not run the t
6. efore insertion and assure the insertion is complete It is recommended to insert the cartridge after the sample loading after 30 seconds elapsed in less than 5 minutes to obtain the optimal result of test 9 When the reaction in the cartridge is completed the FREND System will automatically begin the reading process 10 When the measurements are completed the cartridge will automatically be expelled and the results displayed A Caution Do not disconnect power cord or shut off power from the FREND System while a cartridge is in the reading chamber This may cause a system error 11 If the FREND System is connected to the optional printer press the Print button and the results will be output on the printer paper 12 For more detailed instructions please refer to the FREND System User Manual Procedural notes If a specimen Testosterone concentration is found to be greater than the linearity limit of the assay of 15 00 ng mL and a definitive result is required the specimen should be diluted with low concentration sample that has been previously measured on the FREND Testosterone and then re assayed according to the Assay Procedure The recommended dilution for samples with an initial result of gt 15 00 ng mL is 1 2 Dilutions must be made manually and the final result on the diluted sample calculated manually by multiplying the result obtained on the diluted sample by the dilution factor X Original Unk
7. ere 1 Insert the FREND System electrical cord into an appropriate outlet 2 Insert the Code chip into the Code chip slot at the rear of the FREND System ollowing the arrows 3 Press the Setup button on the Main screen 4 Press the Code chip button on the Setup screen 5 The information embedded on the FREND Testosterone Code chip is automatically saved on the FREND System 6 When the Code chip installation is completed press the OK button to go to the Setup screen 7 Press the Item button on the Setup screen 8 Check the FREND Testosterone cartridge lot number and the installation date of the Code chip 9 Press the Home button to go to the Main screen to begin running external quality control and patient samples Quality control FREND QC Cartridge contains multiple controls to check optic part of the system By testing QC Cartridge part of analytical components of the system of 1 laser power 2 alignment and 3 mechanical integrity are confirmed For each day of patient testing perform QC Cartridge testing Refer to the quality control procedures section in the User Manual of FREND System In brief perform QC Cartridge testing for the following conditions 1 Upon initial setup of the system 2 Each day of patient testing 3 When the system has been transported or moved 4 Whenever there is uncertainty about the performan
8. ests for at least two weeks 4 Monthly as a continued check on storage conditions 5 Whenever problems storage operator or other are identified 6 Or other times as required by your laboratory s standard QC procedures Individual laboratory policy will dictate exactly which control materials and lot numbers should be run the frequency with which controls are to be tested criteria for acceptance of the results and required corrective action to be taken if results do not meet laboratory criteria If any external quality control sample values are out of the acceptable range it will be necessary to investigate the problem before reporting patient results to assure there is not an instrument or software malfunction Do not assay patient samples on the FREND System using FREND Testosterone if quality control on how to determine acceptability of external control material results Each laboratory operates under a different set of regulations Every laboratory must follow the standardized procedures acceptable to the regulatory agencies to which the laboratory is responsible Specimen processing Preparation Remove sufficient cartridges and pretreatment tubes of FREND Testosterone from the refrigerator to test the number of patient samples and required external quality materials Allow the tubes and the sealed pouches containing the cartridges to come to room temperature for 15 30 minutes prior to the start of the testing sequen
9. highest concentration of Testosterone me asurable without dilution The lowest measurable concentration is 0 20 ng mL the assay limit of detection 3 Specimens from patients with heterophilic antibodies such as anti mouse HAMA anti goat HAGA or anti rabbit HARA antibodies maybe show falsely elevated or depressed values or may result in an incomplete test Patients rou tinely exposed to animals or animal serum products can be prone to these types of heterophilic interferences 4 Certain medications may interfere with assay performance All results should be interpreted with respect to the clinical picture of the patient 5 Although hemolysis has an insignificant effect on the assay hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be in terpreted with caution 6 Lipemia has an insignificant effect on the assay except in the case of gross li pemia where interference with the lateral flow of the sample in the cartridge may occur 7 The concentration of Testosterone in a given sample determined with assays from different manufacturers can vary due to differences in assay methods calibration and antibody specificity 8 Please refer to the Specimen Collection and Handling Warnings and Precau tions Storage and Stability and Procedural Notes sections in this insert sheet 9 FREND Testosterone has not been validated in point of care settings 10 FREND Testosterone is to be used
10. nown Concentration of Testosterone Concentration of diluted sample 2 Concentration of low level sample Calculation of results The FREND System performs all sample and reagent handling operations automatically within the cartridge once the sample has been manually loaded to the sample inlet in the cartridge and the cartridge placed into the FREND System The rate of fluorescence produced by the reaction is read at various intervals during the analysis process blank reading are subtracted after which the net rate is automatically converted to Testosterone concentration in ng mL based upon information stored on the FREND Testosterone Code chip This result is then output on the screen and to the optional printer It is also stored in memory on the FREND System Screen displayed for various concentration scenarios Displayed result Description Testosterone concentration Less than 0 20 ng mL align von Testosterone concentration aie Not less than 0 20 ng mL and not higher than 15 00 ng mL Testosterone concentration Higher than 15 00 ng mL 10 Limitations of the procedure 1 When used 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 medical history therapy etc 2 The FREND System paired with a FREND Testosterone cartridge is progra mmed to report 15 00 ng mL as the
11. ntration is calculated by the FREND System Material provided Contents Catalogue number 20 FREND Testosterone cartridge s FRTE 020 20 FREND Testosterone pretreatment tube s 01 FREND Testosterone Code chip 01 FREND Testosterone Package Insert One cartridge contains Testosterone 218 80 21 88 ng Monoclonal anti testosterone antibody 32 0 3 2 ng Fluorescent particles 1 80 0 18 ug One pretreatment tube contains Gold antibody conjugates 30 0 3 0 ug Materials required but not provided The FREND System Micro pipette capable of delivering 35 and 70 uL Heating block for tube and cartridge incubation at 37 C Timer for incubation step Personal protective equipment and biohazard waste Warning and Precautions The FREND Testosterone cartridges are intended for in vitro diagnostic use only Testosterone cartridges are only to be used on the FREND System Testosterone cartridges are disposable single use devices Do not reuse them under any circumstances Allow sealed cartridges to come to room temperature for 15 30 minutes prior to use Cartridges and pretreatment tube should not be frozen Assure the humidity in the laboratory is in the 10 80 range when tests are run Assure the room temperature remains in the range of 22 30 C when tests are run Avoid cross contamination between samples by using a new pipette tip for each new specimen Avoid high humidity direct sunlight or hea
12. ope Community ER aL AANE Invitro diagnostic medical device y A bd Temperature limitation s lt Contains sufficient for lt n gt tests 15 Nano nfek ivd nanoentek com www nanoentekinc com wd Manufactured by NanoEnTek Inc HQ 12F 5 Digital ro 26 gil Guro gu Seoul 08389 Korea Tel 82 2 6220 7940 Fax 82 2 6220 7721 EC REP MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany US Branch NanoEnTek USA Inc 5627 Stoneridge Drive Suite 304 Pleasanton CA 94588 USA Tel 1 925 225 0108 1 888 988 0108 Toll free Fax 1 925 225 0109 Revised on 2015 07 06 16
13. osterone are as Sex Hormone Binding Globulin SHBG also referred to as Testosterone Binding Globulin TeBG and serum albumin Clinically testosterone monitoring is used to help diagnose and differentiate endocrine disorders In males these include hypogonadism testicular failure infertility hypopituitarism and hyperprolactinemia In females changes in serum testosterone levels can be caused by polycystic ovary syndrome adrenal hyperplasia infertility hirsutism amenorrhea obesity and virilization Principle of the assay The FREND Testosterone test cartridge is a one time use rapid competitive immunoassay utilizing fluorescent nanoparticle in microfluidic flow to capture and quantify total testosterone in serum and plasma specimens The drop of 70uL patient sample is placed in the FREND Testosterone pretreatment tube where the sample interacts with a proprietary mix of pretreatment solution Initially patient sample is mixed with testosterone antibody labeled particles forming immune complexes with total testosterone in the patient sample then incubated for 5 minutes at 37 C The drop of 35 uL mixture is added to the FREND Testosterone cartridge interacting with testosterone conjugated fluorescent nanoparticles The mixture moves via Capillary action to the detection region where fluorescent nanoparticle complexes are grabbed The fluorescence intensities from the complexes are measured and total testosterone conce
14. rials are stable until the expiration date on the label when stored at the specified temperature Reagent stability has been demonstrated for twelve months from the date of manufacture The expiration date is clearly indicated on the product box and the cartridges Materials Catalogue number Refrigerator temperature storage 2 8 C FREND Testosterone cartridges FRTE 020 FREND Testosterone pretreatment tubes None Specimen collection and handling Human serum and plasma EDTA and Lithium heparin samples are suitable for use with FREND Testosterone cartridges Follow instructions detailed in this package insert as well as the specimen collection tube manufacturer s instructions for specimen collection and preparation including manufacturer s instructions for centrifugation time and speed For serum a blood sample is collected aseptically without additives by venous puncture After allowing the sample to clot for 30 minutes at room temperature the collection tube should be centrifuged for 10 minutes at 3 000 rpm For plasma EDTA and Lithium heparin a venous blood sample is collected aseptically with the designated additive After allowing the specimen to sufficiently mix with anticoagulant at room temperature the sample tube can be centrifuged for 10 minutes at 3 000 rpm Samples may be stored at 2 8 for up to 6 hours prior to analysis If the analysis is scheduled to be done at some later time the sample should be stored fro
15. t in the area used for cartridge storage Inaccurate results are possible if the sample used is contaminated in any way Using specimens containing clotted fibrin could result in erroneous results Over or under loading the cartridge with sample may result in inaccurate results Human specimens are not used in the preparation of this product however sin ce human specimens will be used for samples and other quality control products in the lab may be derived from human materials Please use Universal Precaution s when handling all specimens and controls Do not use the cartridges and pretreatment tubes beyond the expiration date on the pouch Do not use the cartridge and pretreatment tubes if the pouch is damaged or the seal is broken Perform testing as specified in the Package Insert and User Manual Keep the cartridge and pretreatment tube sealed in the pouch until just ready or use Use the cartridge and pretreatment tube immediately after opening the pouch Wear disposable gloves when handling the cartridges pretreatment tubes and the samples Wash hands thoroughly and often after handling reagent cartridges or samples Do not ingest the silica gel package found in the cartridge pouch estosterone has been designed so that the high dose hook effect does not affect the vast majority of samples Handle specimens in accordance with the OSHA Standard on Bloodborne Pat hogens Storage and Stability All unopened mate
16. xycortisol 1 000 ng mL 94 4 92 8 100 7 Trans Dehydroandrosterone DHEA 10 000 ng mL 106 8 107 3 103 2 13 Analytical sensitivity The limit of blank LoB and limit of detection LoD was determined using guidelines found in CLS document EP17 A LoB was determined from 60 replicate measurements using a calibrator A Testosterone depleted serum LoD was determined using 12 replicates measurements of five low level patient samples LoB ng mL LoD ng mL LoQ ng mL 0 10 0 14 0 14 Interference FREND Testosterone demonstrates lt 10 interference with the following substances at the concentrations indicated below Hemoglobin Bilirubin Triglycerides Total protein and Biotin CLS document EP7 A2 was used to analyze and calculate percent interference using serum samples at three levels of Testosterone within the normal range Substance Concentration Hemoglobin 100 mg dL Bilirubin 15 mg mL Triglyceride 1 g dL Total protein 12 g dL Biotin 30 g dL References 1 Burtis C A and AshwoodE r Ed Tietz Textbook of Clinical Chemistry 2nd Edition W B Saunders Company 1994 1850 51 2 Dunn J F Nisula B C and Rodbard D Journal of Clinical Endocrinology and Metabolism 1981 53 58 68 14 Glossary of symbols Do not reuse me Use by YYYY MM DD Lot number E Catalog number Warning or Caution Manufactured by Authorized representative in the Eur
17. zen at 20 or below for future use Repeated freeze thaw cycles should be avoided Prior to assay slowly bring frozen samples to room temperature 18 25 C and mix gently but thoroughly before test For optimal results avoid grossly hemolytic lipemic or turbid specimens Specimens should be free of aggregated fibrin red blood cells or other particulate matter When pipetting into the FREND Testosterone cartridge sample inlet ensure that bubbles in the sample are avoided Bubbles may restrict flow and result in an incomplete or erroneous test result Procedure Calibration There is no need for calibration to be performed by the end user as is generally required on other automated laboratory equipment All calibration statistics and information have been electronically stored on the FREND Testosterone Code chip included in each box of FREND Testosterone cartridges The FREND Testosterone Code chip is specific for each manufactured lot of FREND Testosterone cartridges Calibration information should always be checked by running external quality control samples to verify that the results obtained for Testosterone on the FREND System using the FREND Testosterone cartridges of a specific lot meet the laboratory criterion for acceptability Code chip installation Please refer to the FREND System user manual for more detailed instructions relative to the Code chip installation Abbreviated instructions follow h
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