For use with the Sofia Quantitative Vitamin D FIA test system only For in vitro diagnostic use INTENDED USE The Sofia Quantitative Vitamin D Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Quantitative Vitamin D FIA test system. REAGENTS AND MATERIALS SUPPLIED Control 1: 25-OH vitamin D in human serum with <0.1% Streptomycin Sulfate (2) Control 2: 25-OH vitamin D in human serum with <0.1% Streptomycin Sulfate (2) Package Insert (1) MATERIALS REQUIRED BUT NOT SUPPLIED IN KIT Sofia Quantitative Vitamin D FIA kit, including: Individually Packaged Test Cassettes (2) Reagent Vials (2) QC Card (located on kit box) Sofia Calibrated micropipette WARNINGS AND PRECAUTIONS Do not use the Controls beyond the expiration date printed on the Vial labels and the outside of the kit box. To obtain accurate results, instructions on the Package Insert must be followed. Inadequate or inappropriate storage of the Controls may yield incorrect test results. Follow Universal Precautions when handling Controls.¹ Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.¹ Dispose of containers and unused contents in accordance with Federal, State and Local regulatory requirements. Wash hands thoroughly after handling. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at quidel.com. Sofia Quantitative Vitamin D Control Set Page 1 of 6
KIT STORAGE AND STABILITY Store the kit at 36 F to 46 F (2 C to 8 C), out of direct sunlight. Unopened Vials are stable until the expiration date printed on the individual Control Vials and outer box. Opened Vials are stable for 30 days after opening. Do not freeze. QUALITY CONTROL TESTING FREQUENCY External Controls should be used to demonstrate that the reagents and assay procedure perform properly. Quidel recommends that Controls be run with the Sofia Quantitative Vitamin D FIA as follows: once for each untrained operator once for each new shipment of kits provided that each different lot received in the shipment is tested as deemed additionally necessary by your internal quality control procedures, and in accordance with local, state and federal regulations or accreditation requirements TEST PROCEDURE Precautions DO NOT open the foil pouch containing the Test Cassette until ready to add the sample. Place the Test Cassette on a clean and level surface. All controls must be at room temperature before beginning the assay. Check expiration date on each individual control vial, test package or outer box before using. Do not use any components past the expiration date on the labels. 1. There are two Controls, Control 1 and Control 2. Each Control will be tested individually. Begin testing with either Control. Control 1 (yellow cap) Control 2 (green cap) 2. Fill a calibrated micropipette with 100 μl of the Control solution. Sofia Quantitative Vitamin D Control Set Page 2 of 6
3. Add Control solution to the Reagent Vial. 4. Invert the Reagent Vial 2 times to mix. The Reagent Vial may also be vortexed to mix. 5. Let the Control sample stand in the Reagent Vial for 5 minutes. Note: The sample will turn a pale pink color during these 5 minutes. 6. Select Run QC from the Main Menu on Sofia. 7. When prompted by Sofia, scan the barcode on the QC Card (located on the assay kit box). 8. When prompted by Sofia, scan the barcode on the Control vial that you are testing. Sofia Quantitative Vitamin D Control Set Page 3 of 6
9. Immediately after the 5 minute incubation is complete, fill a calibrated micropipette with 120 µl of the treated Control solution from the Reagent Vial. 10. Dispense the contents of the micropipette into the Test Cassette sample well. 11. Insert the prepared Test Cassette into the drawer. Then gently close the drawer to start the timer. 12. Sofia will start automatically and display the progress. The test results will be displayed on the screen in approximately 5 minutes. Sofia Display Interpretation Action Vit D: Vit D: Vit D: XX.X ng/ml Passed <XX.X ng/ml Failed >XX.X ng/ml Failed Control result passed. Control result is less than or greater than the QC limits. Continue with testing the next Control or patient sample. Retest with a new Control vial and new Test Cassette. Vit D: [blank] Invalid procedural control. Failed NOTE: Do not perform patient tests or report patient test results if either of the QC test results fail. Repeat the test or contact Quidel Technical Support before testing patient samples. Sofia Quantitative Vitamin D Control Set Page 4 of 6
13. Repeat the process from Step 2 with the second Control. Select Run Control on the Sofia display to proceed. LIMITATIONS Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result. ASSISTANCE If you have any questions regarding the use of this product or if you want to report a test system problem, please call Quidel Technical Support at 800.874.1517 (in the U.S.) or 858.552.1100, Monday through Friday, from 7:00 a.m. to 5:00 p.m., Pacific Time. If outside the U.S. contact your local distributor or technicalsupport@quidel.com. REFERENCES 1. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. U.S. Department of Health and Human Services, CDC, NIH, Washington, DC (2007). 20327 Sofia Quantitative Vitamin D Control Set MDSS GmBH Schiffgraben 41 30175 Hannover, Germany Quidel Corporation 10165 McKellar Court San Diego, CA 92121 USA quidel.com 1357000EN00 (10/18) Sofia Quantitative Vitamin D Control Set Page 5 of 6
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