BioSign hCG CE urine-reader.p65
Contents
1. the transportation of etiologic agents Procedure Test Procedure Summary The procedure consists of adding the specimen to the sample well in the device inserting the device into the DXpress Reader and following the instructions to get the result Procedural Notes e Allow the dropper to fill with sample without air bubbles e Handle all specimens as if capable of transmitting disease e After testing dispose of the BioSign device and the specimen dispenser following good laboratory practices Consider each material that comes in contact with specimen to be potentially infectious Using Dxpress Reader For complete instructions including installation and start up refer to the DXpress Reader User Manual Operators must consult the DXpress Reader User Manual prior to use and become familiar with the processes and quality control procedures Performing Self Check Each time the DXpress Reader is turned on Self Check is automatically performed and the operator may then proceed to Calibration QC If the DXpress Reader is left on or in power save mode the operator should perform Self Check daily as follows From the Main Menu select 2 RUN QC Then select 1 SELF CHECK Self Check takes about 15 seconds PASS or FAIL results will be displayed printed when testing is completed All Self Check items should pass before testing patient samples Note Perform Calibration QC in accordance with your laborat2. P 51103 BioSign hCG Urine Pregnancy Test For Professional n Vitro Diagnostic Use Only Rapid Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin in Urine with DXpress Reader For the Early Detection of Pregnancy PBM CDC Analyte Identifier Code 9642 CDC Test System Identifier Code 49200 Stock No BSP 121 BSP 121 10 Intended Use BioSign hCG Test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin hCG in urine for the early confirmation of pregnancy This test is intended to be used with the DXpress Reader 35 Test Kit 10 Test Kit Summary and Explanation Human chorionic gonadotropin hCG is a glycoprotein hormone produced by the placental trophoblastic cells shortly after the implantation of fertilized ovum in the uterine wall The primary function of hCG is to maintain the corpus luteum during early pregnancy The appearance of hCG in urine soon after conception and its rapid rise in concentration make it an excellent marker for confirmation of pregnancy The hormone can be detected in urine as early as 7 to 10 days after conception The concentration of hCG continues to rise rapidly frequently exceeding 100 mIU mL by the first missed menstrual period and peaking in the 100 000 200 000 mIU mL range by 10 to 12 weeks into pregnancy The hormone is comprised of two non covalently bound dissimilar subunits containing approximately 30 carbohydra
3. Standard HCG levels in normal early pregnant women vary and hCG levels often exceed 100 mIU mL by the first day of the missed menstrual period The test is usually capable of detecting hCG by the first day of the missed menstrual period Performance Characteristics Comparison Study A total of 65 clinical samples were studied These specimens were assayed with BioSign hCG Test and a predicate device according to the respective test s protocol The summary of the results is shown in Table 1 Table 1 BioSign vs Predicate Device BioSign hCG Positive Borderline Negative Total Predicate Positive 37 1 0 38 Device Negative 0 1 26 27 Total 37 2 26 65 Two samples gave discrepant results between BioSign hCG and the predicate devices These two samples contained hCG but the amount of hCG present in these samples was less than 25mIU mL The BioSign hCG gave borderline indeterminate results for these two samples while the predicate device gave 1 positive and 1 negative result for these two samples All discrepant samples had less than 25 mIU mL hCG BioSign hCG Test gave correct results borderline or negative for all these samples Sensitivity To evaluate analytical sensitivity of BioSign hCG Test the following experiment was performed Pooled negative from non pregnant people was spiked with hCG at several levels Each level was tested 20 times with two lots The result is summarized in Table 2 This dat
4. a supports that BioSign hCG Test detects hCG concentrations equal to or greater than 25 mIU mL calibrated to the WHO 4th International Standard Table 2 BioSign hCG Sensitivity Study hCG mIU mL Percent Positive N 0 0 3 0 5 0 10 0 15 30 6 20 80 16 25 100 20 40 100 20 Precision Study The precision of BioSign hCG Test was determined by carrying out the test with hCG spiked into pooled negative samples Four levels of hCG concentra tion were tested for three days with 2 lots and three DXpress readers There were no significant differences between readers between days or between lots Table 3 shows the precision data combining all repeated tests Table 3 Summary of Precision Study Data hCG Conc Total No No of No of No of Correct mIU mL Tested Positive Borderline Negative Results 0 180 0 0 180 100 5 180 0 3 177 98 3 25 180 179 1 0 99 4 40 180 180 0 0 100 Physicians Office Laboratory Evaluation Reproducibility of BioSign hCG test results was evaluated at three physi cians office laboratories using a total of 120 blind control samples Each panel consisted of five negative samples five at 5 mIU mL five at 25 mIU mL and five at 100 mIU mL hCG The results obtained at each site agreed 100 with expected results Specificity The assay is free from interference with other commonly known homologous hormones when tested at the levels specified below Homolog
5. ahl O P Dissociation and Recombination of the Subunits of Human Chorionic Gonadotropin Biochem Biophys Res Commun 40 422 1970 6 Ross G T Clinical Relevance of Research on the Structure of Human Chorionic Gonadotropin Am J Obstet Gynecol 129 795 1977 7 Reuter A M Gaspard U J Deville J L Vrindts Gevaert Y and Franchimont P Serum Concentrations of Human Chorionic Gonadotropin and its Alpha and Beta Subunits 1 During Normal Singleton and Twin Pregnancies Clin Endocrinol 13 305 1980 8 Morrow C P et al Clinical and Laboratory Correlates of Molar Pregnancy and Trophoblastic Disease Am J Obstet Gynecol 50 424 430 1977 9 Dawood M Y Saxena B B and Landesman R Human Chorionic Gona dotropin and its Subunits in Hydatidiform Mole and Choriocarcinoma Am J Obstet Gynecol 50 172 181 1977 10 Braunstein G D Vaitukaitis J L Carbone P P and Ross G T Ectopic Production of Human Chorionic Gonadotropin by Neoplasms Ann Inter Med 78 39 45 1973 11 Murray H Baakdah H Bardell T and Tulandi T Diagnosis and treatment of ectopic pregnancy CMAJ 173 8 905 912 2005 12 Snyder JA et al Diagnostic Considerations in the Measurement of Human Chorionic Gonadotropin in Aging Women Clin Chem 51 1830 5 2005 13 Cole L A Immunoassay of human chorionic gonadotropin its free subunits and metabolites Clin Chem 43 12 2233 2243 1997 14 Steier J A Bergsjo P an
6. d Myking O L Human Chorionic Gonadotropin in Maternal Plasma After Induced Abortion Spontaneous Abortion and Removed Ectopic Pregnancy Am J Obstet Gynecol 64 391 394 1984 15 Wilcox A J Weinberg C R O Connor J F Baird D D Schlatterer J P Canfield R E Armstrong E G Nisula B C Incidence of early loss of pregnancy N Engl J Med 1988 319 189 194 Symbols Key H z EHE RE m x lt v rd e YYYY MM DD 30 C 86 F xcs A Max Min E a cS lt 4 8 lt lt Manufactured by CE Mark Authorized Representative In Vitro Diagnostic Medical Device Catalog Number Consult Instructions for Use Batch Code Use By date in year month day format Temperature Limitation Contains sufficient for lt n gt tests Do not reuse Contents Test Device Transfer Pipette Instructions for Use Pregnancy Test BioSign is a Registered Trademark of Princeton BioMeditech Corporation Patent No 5 559 041 cE 2000 PBM Printed in U S A Revised Apr 2006 P 51103 0426BL MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany 49 68 94 58 10 20 Manufactured by mal Princeton BioMeditech Corporation Princeton NJ 08543 7139 U S A 1 732 274 1000 www pbmc com
7. hCG present in men and in non pregnant women concentrations 3 to 100 mIU mL may result in positive results User Quality Control Internal Control Each BioSign hCG Test device has a built in control The Control line is an internal positive procedural control A distinct reddish purple Control line should appear at the C position indicating an adequate sample volume is used the sample and reagent are wicking on the membrane and the reagents at the Control line and the conjugate color indicator are reactive In addition the clearing background in the Result window by providing a distinct readable result may be considered an internal negative procedural control If background color appears in the Result window which interferes with the result interpretation of the reader then the result is invalid If the problem persists contact PBM for technical assistance External Control External controls may also be used to assure that the reagents are working properly and that the assay procedure is followed correctly It is recommended that a control be tested before using a new lot or anew shipment of kits as good laboratory testing practice and that users follow federal state and local guidelines for quality control requirements For information on how to obtain controls contact PBM Technical Services Expected Values BioSign hCG Test is capable of detecting hCG level of 25 mIU mL calibrated against the WHO 4th International
8. ing of another specimen obtained at least 48 hours later is recommended e The hCG level may remain detectable for several weeks after normal delivery delivery by caesarean section spontaneous abortion or thera peutic abortion e The test is highly sensitive and specimens which test positive during the initial days after conception may later be negative due to natural termination of the pregnancy Natural termination occurs in 22 of clinically unrecognized pregnancies and 31 of pregnancies overall Subsequent testing of a new urine sample after an additional 48 hours is recommended in order to confirm that the hCG level is rising as indicated in a normal pregnancy e Elevated hCG levels have been reported in patients with both gestational and nongestational trophoblastic diseases The hCG of trophoblastic neoplasms is similar to that found in pregnancy so these conditions including choriocarcinoma and hydatidiform mole should be ruled out before pregnancy is diagnosed e The physician should evaluate data obtained with this kit in light of other clinical information e Samples which contain excessive bacterial contamination or which have been subjected to repeated freezing and thawing should not be used because such specimens can give spurious results e Degradation of hCG in sample may occur by a certain protease during storage even at 4 C and give a negative test result e Inrare occasions persistent low levels of
9. ory procedures Consult the DXpress Reader User Manual for more information Testing Patient Samples Patient samples may be tested using the DXpress Reader Scheduler mode as described below To use other modes batch mode or read now mode consult the DXpress Reader User Manual 1 Open the pouch and remove the test device e Write the patient ID on the test device e Place the test device on a level surface 2 Entertest information in the DXpress Reader e From the Main Menu select 1 RUN PATIENT Scan lot number barcode from the box or pouch e Confirmtest device information and lotnumber as displayed onthe screen and press ENTER Scan or enter the Operator ID e Scan or enter the Patient ID e Fromthe Incubation Time window select SCHEDULER 3 Addpatient sample to the test device by holding the dropper in avertical position and adding 3 drops of sample into the sample well Press ENTER on the Dxpress Reader Add 3 drops 110 uL A Oo 99y 4 Place the test device inthe Reader tray and close the tray 5 After 5 minutes of incubation the DXpress Reader will automatically display the results on the screen e Results may be printed by pressing PRINT button e Atthis point the test device may be removed and appropri ately discarded Interpretation of Results Positive The instrument will automatically determine the result as positive if the test line intensit
10. ot interchange materials from different product lots and do not use beyond the expiration date e The test device should remain in its sealed pouch until ready for use Storage and Stability BioSign hCG Test kit is to be stored at 2 C to 30 C 35 F to 86 F in the sealed pouch Specimen Collection and Preparation e Approximately 110 uL of sample is required for each test e Specimens containing particulate matter may give inconsistent test results Such specimens should be clarified by centrifugation prior to assaying e Frozen specimens must be completely thawed thoroughly mixed and brought to room temperature prior to testing by allowing the specimens to stand at room temperature for at least 30 minutes e For optimal early detection of pregnancy a first morning urine specimen is preferred since it generally contains the highest concentration of hCG of the day However randomly collected urine specimens may be used e Collect the urine specimen in a clean glass or plastic cup Specimen Storage e If testing will not be performed immediately the specimens should be refrigerated 2 C to 8 C for up to 72 hours prior to assay e Forprolonged storage specimens should be frozen and stored below 20 C Frozen specimens must be completely thawed thoroughly mixed before using Avoid repeated freezing and thawing e Ifspecimens are to be shipped they should be packed in compliance with Federal regulations covering
11. ous Hormones hFSH 1000 mIU mL hLH 300 mIU mL hTSH 1000 pIU mL Interfering Substances Potentially interfering substances were prepared at the following concentra tions containing either 0 or 25 mIU mL hCG These samples were tested with the BioSign hCG Test No interference was found Table 4 at these concentration Table 4 Interfering Substances and Concentrations Tested Substance Added Concentration Added Acetaminophen 20 mg dL Acetylsalicylic Acid 20 mg dL Ampicillin 20 mg dL Ascorbic Acid 20 mg dL Atropine 20 mg dL Caffeine 20 mg dL Gentisic Acid 20 mg dL Phenothiazine 20 mg dL Phenylpropanolamine 20 mg dL Salicylic Acid 20 mg dL Tetracycline 20 mg dL Bilirubin 1 mg dL Glucose 2000 mg dL Hemoglobin 1 mg dL Ketones 100 mg dL References 1 Braunstein G D Rasor J Adler D Danzer H and Wade M E Serum Human Chorionic Gonadotropin Levels Throughout Normal Pregnancy Am J Obstet Gynecol 126 678 1976 2 Krieg A F Pregnancy Tests and Evaluation of Placental Function in Clinical Diagnosis and Management by Laboratory Methods 16th ed Henry J B ed W B Saunders Co Philadelphia pp 680 1979 3 Brody S and Carlstrom G Immunoassay of Human Chorionic Gonadot ropin in Normal and Pathologic Pregnancy J Clin Endocrinol Metab 22 564 1962 4 Hussa R O Human Chorionic Gonadotropin A Clinical Marker Review of its Biosynthesis Ligand Review 3 6 1981 5 Swaminathan N and B
12. te by weight The alpha subunit is structurally similar to other human pituitary glycoprotein hormones whereas the beta 8 subunit confers unique biological and immunological specificity to the molecule Principle The BioSign hCG Test is a rapid urine test for detecting hCG qualitatively The test employs a solid phase chromatographic immunoassay technology to detect elevated levels of hCG in urine with a high degree of sensitivity In the test procedure sample is added to the sample well with a transfer pipette If hCG is present in the specimen it will react with the conjugate dye which binds to the antibody on the membrane to generate a colored line The DXpress Reader interprets the test result automatically by comparing the intensity of the test line to the preset cutoff value The hCG levels greater than or equal to 25 mIU mL are reported as positive Samples containing less than 25 mIU mL are reported as either negative or borderline Reagents The BioSign hCG Test kit contains complete reagent components and materials to perform the test Materials Provided e BioSign hCG Test Each device contains mouse monoclonal and goat anti hCG antibodies e Disposable dropper e Package insert Materials Required but Not Provided e Specimen cup e DXpress Reader Materials Recommended but Not Provided e Timer e External positive and negative controls Precautions e For in vitro diagnostic use only e Do n
13. y is greater than or equal to 25 mIU hCG mL and confirm that the control line intensity meets the minimum requirement Negative The instrument will automatically determine the result as negative if the test line intensity is less than 25 mIU hCG mL and confirm that the control line is present valid test Borderline Results Samples reported as borderline are considered indeterminate and the operator is advised to repeat the test with a new specimen obtained 48 72 hours later Invalid The instrument will automatically determine if a procedural error has occurred by confirming that the control line is not present invalid test If the result is invalid the sample should be retested with a new device If the problem persists contact your local distributor of PBM Limitations e The result cannot be interpreted visually The result can only be read by the DXpress Reader e An extremely low concentration of hCG during the early stage of pregnancy can give a negative result In this case testing of another specimen obtained at least 48 hours later is recommended e A false negative result could be possible in case of ectopic pregnancy due to the fact that the concentration of hCG level tends to be lower than those with a normal pregnancy e Low levels of hCG have been reported in non pregnant females with no history of ectopic pregnancy trophoblastic disease or germ cell tumors In the case of Borderline test results test
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