Regional Medical Laboratory

Bacterial Vaginosis/Vaginitis Panel (BD Affirm™)

CPT code: 87510, 87660, 87480

RML is pleased to announce that we are now offering a vaginosis panel by molecular analysis. We will be utilizing the Becton Dickinson Affirm™ test, which is a qualitative molecular test to detect the presence of Candida species, Gardnerella vaginalis, and Trichomonas vaginalis. The detection threshold for Candida species and Gardnerella vaginalis distinguish between normal flora and clinically significant levels of organisms. Microscopy detection for Trichomonas vaginalis can be negative in up to 50% of women with culture-confirmed trichomoniasis. The BD Affirm™ provides more accurate detection of trichomoniasis. There is a broad differential for the diagnosis of vaginitis, and successful treatment depends on an accurate diagnosis. Published performance data for the BD Affirm™ test is as follows:

*Compared to culture (symptomatic patients)
**Compared to wet mount (symptomatic and asymptomatic patients)

Specimen Requirements:

This collection system consists of a sample collection tube, sterile swab, and ATTS (ambient temperature transport solution). The ATTS must be used with the sample. The sample is stable for 72 hours at ambient or refrigerated temperatures.
NOTE: Specimens in Surepath™ media are not an acceptable specimen for this test

Testing Schedule:

This assay is set up Monday through Friday and reports 1-3 days following set up.

Molecular Clostridium difficile

CPT code: 87493

This is a molecular test that amplifies the pathogenic locus of the toxin producing section of the DNA and amplifies it by LAMP (loop mediated amplification technology) so it can be detected by a turbidity. The method used is called iLLUMIGENE by Meridian Bioscience.

Advantages over current EIA testing

Sensitivity and specificity are 95.2% and 95.3% as compared to the gold standard of toxigenic culture. The toxin EIA test has variable sensitivity depending on the study, but ranges from 35-80%. Requires only one specimen; some literature states that with EIA testing up to 3 stools needed to rule out. FDA approved for children and infants under the age of 2. The EIA test is not.

Specimen Requirements:

Specimens should be transported (if possible) at 2-8C, and stored at 2-8C before testing. Specimens should be tested as soon as possible, but may be held up to 24 hours at room temp (21-27C) or 5 days refrigerated. Specimens that can not be tested within these times should be frozen immediately and stored at -20C until tested. Specimens may be frozen and thawed once.
Formed stools will be rejected. Stools should be soft; take shape of container or liquid.

Testing Schedule:

As this test is a highly complex molecular test, it will be run twice daily effective June 6, 2011.
The cutoff time for specimens will be 11AM and 11PM. The specimens that arrive after the cutoff time will be tested on the next run.
Weekend schedule will be a 4PM run on Sunday.
No repeat testing unless 4 days have passed, or patient has a change in antibiotic regimen and has developed diarrhea.

Fecal Lactoferrin

CPT code: 83630

A qualitative assay that is 90% specific for identifying inflammation in patients with active Inflammatory Bowel Disease (IBD) that is a noninfectious inflammatory diarrhea e.g. IBD. It is highly specific to rule out Irritable Bowel Syndrome (IBS), useful in differentiating IBS from IBD. <10% of celiac patients will be positive for lactoferrin. Lactoferrin will be positive where you have a neutrophilic inflammatory process, i.e. bacterial derived inflammatory diarrhea (Salmonella, Shigella, Campy, C. difficile.).

Fecal Lactoferrin is a better test than non-standardized microscopic examination for WBC's (Stool for Polys). The use of fecal lactoferrin to screen for inflammatory diarrhea selects specimens for which stool culture is fivefold more likely to yield an invasive bacterial pathogen.

Specimen Requirements:

Raw stool no preservatives.
Unpreserved stool can be stored at room temp or 2-8C for up to 2 weeks from time of collection, then stored frozen at -20C or below.
Specimens in transport media, 10% Formalin, PVA or other fixatives are Not Acceptable.
This test may not be appropriate for immunocompromised persons.
Stool samples from breast fed infants should not be used with this assay, as lactoferrin is a component of breast milk.

Testing Schedule:

This assay is set up Monday through Friday and reports 1-3 days following set up.

Trichomonas Antigen

CPT code: 87808

This immunochromatographic test for Trichomonas antigen is the most appropriate test to identify Trichomonas organism. This test will detect presence of viable or non viable organisms. Which is a very effective method over the microscopic examination, since extended times between collection and examination, often exceeded 24 hours, makes visual identification of non-motile organism difficult and often unsuccessful.

Specimen Requirements:

Saline wet prep
24hrs Room Temperature or 36hrs Refrigerated (Do Not Freeze).
BBL culture swab Red top or White top (No Blue top with Gel)
24hrs Room Temperature or 36hrs Refrigerated or frozen.
Dry polyester or rayon swab in a clean, dry container
24hrs Room Temperature or 36hrs Refrigerated or frozen.

Testing Schedule:

Ideally swabs should be processed as soon as possible after specimen collection.
This assay is set up Sunday through Saturday and reports 1-2 following set up.

Vaginosis Profile from Swab with Trichomonas Antigen

CPT code: 87205, 87808, 82120

This vaginal profile provides an interpretation of they types of vaginal pathology seen in yeast infections, Trichomonas vaginalis, bacterial vaginosis and even mixed flora infections. The Trichomonas antigen along with gram stain and evaluation for yeast, clue cells, white blood cells and all bacterial types present. Whiff test (amine test) is reported as positive or negative.

Specimen Requirements:

BBL Red top culturette in Amies media (double swab)
24hrs Room Temperature or 36hrs Refrigerated (Do Not Freeze).
BBL White top culturette (double swab preferred)
24hrs Room Temperature or 36hrs Refrigerated (Do Not Freeze).
BBL Blue top swabs are Not Acceptable.
Samples contaminated with preparations containing iodine or by the immediate prior use of vaginal lubricants are not recommended.

Testing Schedule:

Ideally swabs should be processed as soon as possible after specimen collection.
This assay is set up Sunday through Saturday and reports the same day as set up.

Yeast Culture

CPT code: 87106

This test was developed as an alternative to the traditional fungal culture (C FUNGUS) which has turn around time approaching 4 weeks. Specimens are plated on chromogenic agar for ease of early identification and final reports are issued within 8 days. Susceptibilities will not be routine performed but would be available upon request.

Specimen Requirements:

BBL Swabs in bacterial transport media
Any color swab, ETM or Raw stool, Urine in or Monovettes are acceptable.
Specimen Stability: 24hrs Room Temperature or 36hrs Refrigerated (Do Not Freeze).
Specimen Source needs to be indicated.
Acceptable Sources include genital, fecal, urine and oral cavity specimens (mouth, gums, throat, esophagus, tongue, teeth, etc.)
Sources of foley catheter tips, in viral transport, parasite parapaks are Not Acceptable.

Testing Schedule:

This assay is set up Sunday through Saturday and reports within 8 days following set up.