T5002 - LEUKO-TEST
A latex agglutination test for the detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and inflammatory diarrhea.
Diarrheas are classified as inflammatory or noninflammatory. Inflammatory diarrheas represent a much more serious problem than noninflammatory diarrheas because they can develop into life-threatening illnesses. The procedure used to identify inflammatory diarrheas has been the microscopic detection of leukocytes in fecal smears. This procedure often gives unreliable results because fecal leukocytes can be difficult to identify and they are highly unstable. The LEUKO-TEST is an improved method for fecal leukocyte detection. It is a latex agglutination test for detecting lactoferrin released from leukocytes in fecal specimens. The test is rapid and standardized, and can be used as a screen to reduce hospital costs while improving healthcare for the patient.
Features
- Rapid Screen
- Reduces healthcare costs
- Highly standardized
- Easy to use
- Better than microscopy for fecal leukocytes
Further Information
Frequently Asked Questions
Q: What does the LEUKO-TEST detect?
A: The test detects elevated levels of lactoferrin as a marker of fecal leukocytes and intestinal inflammation. The 1:50 dilution of the fecal sample was designed so that only the lactoferrin present in an excessive number of neutrophils or in an inflammatory condition such as IBD will be detected. Eosinophils (excreted during allergic diarrheas), monocytes and lymphocytes (found in some cancers) will not be detected by this test. Breast fed babies should not be tested because there are large amounts of lactoferrin present in mother's milk.
Q: How do I handle solid samples in the LEUKO-TEST?
A: The test is recommended for diarrheal specimens. We do not recommend testing solid samples; however, it is difficult to refuse to test a sample based on its consistency. We recommend that you thoroughly mix solid specimens with either PBS, sterile water or saline until they reach the consistency required for them to be drawn up into the pipettes provided with the kit. This allows for thorough mixing and more precise sampling/diluting.
Q: Can I use preserved samples in the LEUKO-TEST?
A: No, only fresh, frozen, or samples in transport media such as Cary Blair or C&S can be used; however, these samples must arrive at the correct dilution (1:5) and must be further diluted. Make an extra 1:10 dilution in the kit Diluent. The final dilution must be 1:50. Samples in fixatives (formalin, SAF, PVA or MF) cannot be used.
Q: What does it mean when the Negative Control Latex reacts with the specimen?
A: Although this is rare, some specimens may react nonspecifically with the Negative Control Latex. This type of result must be reported as indeterminant.
Q: Can a shaker be used for mixing the latex with the specimen?
A: Yes. Each shaker (rotator) is different so use the highest rpm setting that allows the latex to spread within the reaction circle.
Q: The LEUKO-TEST was positive. Does this mean that the patient has an infection?
A: No, the patient has an inflammatory condition in their intestine. This may mean an infection, but it can also mean that the patient has inflammatory bowel disease.
Q: Can I report a positive result if the agglutination occurred after the 3-minute incubation period?
A: No. The 3-minute cutoff time is extremely important. Healthy persons have low levels of lactoferrin in their feces but they will test negative as long as the 3-minute incubation time is followed.
Q: I've been using the LEUKO-TEST and noticed that the Sensitized Latex runs out before the Negative Control Latex. Am I doing something wrong?
A: No. The test is designed to do a minimum of 50 patient tests. Each test requires two drops of Sensitized Latex and one drop of Negative Control Latex. Thus, the Sensitized Latex is the limiting reagent and will run out more quickly.
Q: Is the LEUKO-TEST CLIA-waived?
A: No.
Q: What is the CPT code for the LEUKO-TEST?
A: According to the 2006 coding, the CPT code is 83630. In the past, we have used CPT code 86403 which is still available. However in 2005, a new CPT code - #83630 was issued specifically for lactoferrin.
Q: Does this CPT code reimburse more than the code for Gram/Methylene Blue/Wright's Stains by microscopy?
A: Yes, the average reimbursement for code #86403 is $14.00 per test, whereas an average microscopy reimbursement is only $7.00.
Q: Can other body fluids be tested using the LEUKO-TEST?
A: No. The LEUKO-TEST was designed to be used with human diarrhea specimens. The performance characteristics for detecting lactoferrin in other body fluids have not been defined.