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Immune Assay





Introduction

An immune assay is a special method of testing to measure or detect certain substances. This sophisticated test uses the properties of the immune or infection-fighting system. It is usually used when the amount of material to be detected is very small. It is most commonly performed on a sample of blood, though other body fluids may be used.
Who is a candidate for the test?
The immune assay has many uses, including:



  • testing for infections, such as HIV, Borrelia burgdorferi.\ It is passed to humans through tick bites. ',CAPTION,'Lyme Disease');" onmouseout="return nd();">Lyme disease, or Chlamydia trachomatis\. Sexually transmitted disease refers to any contagious disease transmitted from one person to another during sexual contact. In women, the infection usually occurs in the urinary tract, pelvis, or cervix. The cervix is the opening between the vagina and the uterus. ',CAPTION,'Chlamydia Infection in Females');" onmouseout="return nd();">chlamydia
  • testing for autoimmune disorders, which are conditions in which a person's immune system attacks his or her own body. These disorders include systemic lupus erythematosus and rheumatoid arthritis.
  • testing for hormone levels, such as some types of pregnancy testing or thyroid function tests, used to help diagnose conditions of the thyroid gland
  • testing for certain cancers, such as the blood cancers leukemia and multiple myeloma
  • detecting the presence, or measuring the level, of medications in a person's body
  • Other uses of this testing method are also possible. The immune assay is being used more and more commonly.
    How is the test performed?
    First, a sample of the fluid to be tested is obtained. This may mean collecting blood saliva, urine, or cerebrospinal fluid (CSF) sample. CSF is the fluid that surrounds the brain and spinal cord, and is obtained with a spinal tap. The fluid to be tested is collected into a special container and sent to the lab for testing.
    There are many different methods of performing the test. Most involve mixing antibodies or antigens with the body fluid being tested. Antibodies are special proteins made by the immune system. The body makes these proteins when there is an infection or other threat. An antigen is any substance that causes the immune system to respond or attack. It might be bacteria, a virus, a medications, or even the person's own body.
    If the healthcare provider is trying to detect antibodies in the blood, antigens are usually used in the test. If the goal is to detect antigens, antibodies are used. For example, a test may be done to look for Lyme disease antibodies. Pieces of the bacteria that cause Lyme disease, the antigen, are put in a container. The person's blood is then mixed with the antigen. If the person has antibodies against the Lyme disease bacteria, they will react with the antigen. This reaction can be detected in different ways. A positive reaction means the person may have Borrelia burgdorferi.\ It is passed to humans through tick bites. ',CAPTION,'Lyme Disease');" onmouseout="return nd();">Lyme disease. If no reaction occurs, the person probably doesn't have Lyme disease.

    What do the test results mean?
    Interpretation of the test results depends on why the test was ordered. For example, the test results may indicate that a woman is or isn't pregnant. Or the test results may mean that a person does or doesn't have a certain infection. The healthcare provider can discuss the results and what they mean.



    From  Equipment used Right now :Cobas E411 Immunoassay System Routine Operation from Cobas 




    Applicable To :Employees of the Gundersen Health System Laboratories, Gundersen Tri-County Hospital laboratories, Gundersen St. Joseph’s Health Services laboratories and Gundersen Boscobel Area Hospital laboratories, Gundersen Palmer Lutheran Hospitals and Clinics laboratory and Gundersen Moundview Hospital and Clinics laboratories.



    PROCEDURE:Turn front switch on analyzer to OFF position before doing maintenance procedures in the morning.1.Remove reagent compartment lid and reagent wheel to check for condensation inside. Wipe out any moisture. Replace wheel, replace lid.2.Clean S/R probe with distilled H2O on gauze, and then dry gauze. Use 70% Isopropanol when probe is visibly dirty. Turn front switch to ON position. When analyzer has returned to standby, proceed with the following:  

    Check Inventory: a.Each test reagent cartridge is displayed with # of tests and position #. Additional cartridges to be added should warm >45 minutes prior to loading. b.Check for sample tips and cups. Do not add to partial racks. c.Replace ProCell/Clean Cell if less than 20%. Move full bottles from left side to right and load new bottles on left. d.Empty waste containers. e.Check volume of System Water. f.Do a ‘clear sample data’ from the Overview screen.



    Calibrate: Refer to “Calset calibration Instructions” for handling of calibrator. Confirm lot number by checking Calibration, Calibrator, and Test. If lot number is not on this screen, go to Install tab, insert card in slot and select BC Card Scan. a.Allow calibrator vials to warm ~15 minutes before loading. b.Load on ring aligning the slight extension on the rim of the calibrator vial with the notch in the hole on the ring. Open caps to 90o angle. c.Press START on keyboard. e411 will read barcodes on vials and perform calibration for that test


    To Run QC:a.(If running behind calibrators, leave a space open before inserting controls.) Allow calibrator vials to warm to room temperature before loading.b.Allow control cups to warm 15 minutes before loading. Replace ring with sample disk.c.Load control cups on ring. Manually program by selecting QC from Overview screen, then Control, Position Assignment, and select control and position, then assign.d.Controls are identified by letter and are poured into large Hitachi cups.e.Press START on right side of screen and START on the START screen.f.Be sure to unassign positions for QC after running QC, so other samples may be run in those same positions. From Overview screen, select QC, Control, and Position Assignment; then, select control, position, and remove. 


    Standby reagent packs:a.Place new reagent pack on e411, do a reagent scan.b.Calibrate all new packs. To program calibration, from Overview screen, touch Calibration, status, highlight standby, select manual, save. Check on system overview to see if done correctly. Allow controls to warm to room temperature before loading.c.Replace ring with sample disk


    To run QC on standby pack, go to QC, status, standby bottle QC, check box, OK. Check on system overview to see if done correctly



    Place tube(s) in sample disk, barcodes facing out. Press START, and then START.    


    To run a STAT sample, if e411 disk is currently sampling other specimens, touch Work Place, Test Selection, Stat (E), type in position #, and test(s). Place tube in proper position (bar code facing out) and touch Save. Touch Stat mode on right side of screen, START and START. Return to home screen and Sample Tracking to make sure sample was programmed in as STAT.

    If disk is in S. Stop, samples can be added by starting at the STOP tube. Place new ones in sample disk, bar codes facing out. Touch START and START.

    Directions to print out selected reports when interface is down.
     a.If the interface goes down, the instrument must be in STANDBY

    b.Go to Workplace, data review. Select data by clicking on what samples you want to print or do a sample range start and end. Click on Print, highlight result report, click on print, printout.   


    Directions for Retransmission of cobas e411 results  


    a.To retransmit specimens when the interface is down: Once the interface comes back upgo to Workplace, Data review, select sample, sample range start, click on last sample, click on sample range end.




    To delete samples one at a time, from data review screen, select samples, delete record




    After transmitting the test to the host Go to Utility, page 2, Documentation setup, upload, ok.Refer to Roche Diagnostics cobas e411 System Operator’s Manual for detailed instruction.




    Reference 
     Harrison's Principles of Internal Medicine, 1998, Fauci et al.

    Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers for Medicare and Medicaid Services (CMS), COLA and/or CLIA. 

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