OSOM Mono Test PDF

41 OSOM® Mono Test CLIA Complexity: Non-Waived for Serum and Plasma CLIA Complexity: Waived for Whole Blood FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. INTENDED USE The OSOM® Mono Test is intended for the qualitative detecti...

41 OSOM® Mono Test CLIA Complexity: Non-Waived for Serum and Plasma CLIA Complexity: Waived for Whole Blood FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. INTENDED USE The OSOM® Mono Test is intended for the qualitative detection of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis. SUMMARY AND EXPLANATION OF TEST The diagnosis of infectious mononucleosis (IM) is suggested on the basis of the clinical symptoms of fever, sore throat and swollen lymph glands. The highest incidence of symptomatic IM occurs during late adolescence (15-24 years of age). Infectious mononucleosis is caused by the Epstein-Barr Virus (EBV)1,2. The laboratory diagnosis of IM is based on the detection of IM heterophile antibodies. These heterophile antibodies are directed against antigens found in bovine, sheep and horse erythrocytes. The OSOM Mono Test utilizes an extract of bovine erythrocytes to give the required sensitivity and specificity. PRINCIPLES OF TEST The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture and the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte extract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result. KIT CONTENTS AND STORAGE 25 Test Sticks in a container 25 Test Tubes 25 Transfer Pipettes 25 Capillary Tubes with 1 Capillary Bulb 1 Diluent (contains buffer with 0.2% sodium azide) 1 Mono Positive Control (contains rabbit anti-beef stroma in tris buffer with 0.2% sodium azide and 0.05% gentamycin sulfate preservatives) 1 Mono Negative Control (contains goat albumin in tris buffer with 0.2% sodium azide) 1 Work Station 1 Directional Insert 2 Additional test sticks have been included in the kit for external QC testing Note: Extra components (tubes, pipettes, capillary tubes, capillary bulb) have been provided for your convenience. Store the Test Sticks and reagents tightly capped at 15°-30°C (59°-86°F). Do not use the Test Sticks or reagents after their expiration dates. MATERIALS REQUIRED BUT NOT PROVIDED Specimen collection containers. A timer or watch. WARNINGS AND PRECAUTIONS Warning H317: May cause an allergic skin reaction. P280: Wear protective gloves/protective clothing/eye protection/face protection. For in-vitro diagnostic use only. Follow your laboratory safety guidelines in the collection, handling, storage and disposal of patient specimens and all items exposed to patient specimens.  42 The Diluent and Controls contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azide. For sites permitted to dispose of material down a sink: large quantities of water must be used to flush discarded control material down a sink. The Capillary Bulb contains dry natural rubber. Do not interchange or mix components from different kit lots. SPECIMEN COLLECTION AND PREPARATION Serum, Plasma or Whole Blood Sample Obtain specimens by acceptable medical technique. Collect whole blood samples using a tube containing EDTA or heparin as an anticoagulant. Other anticoagulants have not been tested. Serum and plasma specimens may be refrigerated (2°-8°C; 36°-46°F) and tested within 48 hours; serum and plasma specimens held for longer times should be frozen (below -10°C; 14°F) and tested within 3 months. Test whole blood specimens within 24 hours. Specimens must be at room temperature (15°-30°C; 59°-86°F) when tested. Fingertip Whole Blood Hold the capillary tube horizontally while collecting the sample. Holding the capillary tube near the red circle, touch the other end of the capillary tube to the drop of blood on the patient’s finger. Fill the capillary tube completely. Place the small end of the black bulb onto the capillary tube. Place your fingertip over the opening in the bulb. Squeeze the bulb to dispense the whole blood sample into the test tube. QUALITY CONTROL External Quality Control For external QC testing, use the controls provided in the kit. Add one free falling drop of control to the Test Tube and then proceed in the same manner as with a patient sample. Quality Control requirements should be established in accordance with local, state and federal regulations or accreditation requirements. Minimally Sekisui Diagnostics recommends that positive and negative external controls be run with each new lot and with each new untrained operator. Some commercial controls may contain interfering additives. The use of these controls is not recommended. Internal Quality Controls The OSOM Mono Test provides two levels of internal procedural controls with each test procedure. The red Control Line is an internal positive control. The Test Stick must absorb the proper amount of sample and be working properly for the red Control Line to appear. A clear background is an internal negative control. If the test has been performed correctly and the Test Stick is working properly, the background will clear to give a discernible result. If the red Control Line does not appear, the test is invalid. If the background does not clear and interferes with the test result, the test may be invalid. Call Sekisui Diagnostics Technical Assistance if you experience either of these problems. LIMITATIONS As with all diagnostic assays, the results obtained by this test yield data that must be used as an adjunct to other information available to the physician. The OSOM Mono Test is a qualitative test for the detection of IM heterophile antibody. A negative result may be obtained from patients at the onset of the disease due to heterophile antibody levels below the sensitivity of this test kit. If symptoms persist or intensify, the test should be repeated. Some segments of the population with acute IM are heterophile antibody negative1.  43 TEST PROCEDURE Absorbent End Result Window Handle End Addition of Specimen: For serum, plasma or whole blood samples in tubes: Use the Transfer Pipette provided and add one drop to the Test Tube. For fingertip blood: After filling a capillary tube end to end, dispense all of the blood into the Test Tube. Slowly add 1 drop of Diluent to the bottom of the Test Tube. Mix. Remove the Test Stick(s) from the container. Re-cap the container immediately. Place the Absorbent End of the Test Stick into the treated sample. Leave the Test Stick in the Test Tube. Read results at 5 minutes. Positive results may be read as soon as the red Control Line appears.  44 INTERPRETATION OF TEST RESULTS Notes A blue or red line which appears uneven in color density is considered a valid result. A blue Test Line and a red Control Line is a positive result for the detection of infectious mononucleosis heterophile antibody. Note that the blue line can be any shade of color and can be lighter or darker than the line in the picture. Negative A red Control Line but no blue Test Line is a negative result. No infectious mononucleosis heterophile antibody has been detected. If after 5 minutes, no red Control Line appears or background color makes reading the red Control Line impossible, the result is invalid. If this occurs, repeat the test on a new Test Stick or call Sekisui Diagnostics Technical Assistance at (800) 332-1042 (U.S. only) or (781) 652-7800 The appearance of a dry white line located near the Test and/or Control line positions has been observed on some test sticks. When present it can remain visible at the read time. This artifact is most often seen with plasma or serum specimens and has no impact on the performance of the assay. NORMAL VALUES Negative