Test ID: CDFAW
Chlamydia trachomatis, Fluorescence Staining of MicroTrak Slides
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Detecting Chlamydia trachomatis in symptomatic or high-risk, asymptomatic females, and in symptomatic males
Detecting all 15 serotypes of Chlamydia trachomatis in endocervical, male urethral, conjunctival, rectal, and nasopharyngeal specimens
Method Name A short description of the method used to perform the test
Direct Immunofluorescence
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Chlamydia Trachomatis (Smear)
Chlamydia Trachomatis Direct FA/Smear
Direct FA/Smear, Chlamydia Trachomatis
Microtrak Smear, Chlamydia Trachomatis
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
In suspected cases of child abuse, culture is the only recommended method of diagnosis.
Specimen source is required.
Submit only 1 of the following specimens:
Swab specimen must be collected using Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Type: Urethra (Males Only)
Container/Tube: Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Volume: Swab
Collection Instructions:
1. Patient should not have urinated for at least 1 hour prior to collection.
2. Insert a small Dacron swab 2 to 4 cm into urethra.
3. Rotate swab and withdraw.
Slide preparation:
1. Slides made from swab specimens should be prepared immediately after specimen collection.
2. Firmly roll 1 side of swab over top half of well, then roll other side over bottom half. Cover entire well and stay within well perimeter.
3. Check coverage.
4. Allow specimen to completely air dry.
5. Lay slide flat; flood with 0.5 mL methanol fixative and let entire quantity evaporate. To speed evaporation, tip slide after 5 minutes to drain excess fixative.
6. For best results, store/transport either at room temperature (20-30 degrees C) or refrigerated at 2 to 8 degrees C, and stain within 7 days of collection. If not stained within 7 days, fixed specimen should be stored at -20 degrees C.
Specimen Type: Cervical (cytobrush)
Container/Tube: Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Volume: Swab
Collection Instructions:
1. Wipe exocervix with cotton or Dacron swab to remove excess mucus. Dispose of swab.
2. Gently insert cytobrush into endocervical canal past squamocolumnar junction.
3. Leave in place 2 to 3 seconds.
4. Rotate cytobrush 1 full turn (360 degrees).
5. Withdraw cytobrush without touching any vaginal surfaces.
Slide preparation:
1. Slides made from cytobrush specimens should be prepared immediately after specimen collection.
2. Place the portion of the cytobrush containing the specimen across the center of the well.
3. Rotate and twist the brush, moving the brush back and forth across the well. Liquid clinging to the brush will disperse cells across the well.
4. Check coverage.
5. Allow specimen to completely air dry.
6. Lay slide flat; flood with 0.5 mL methanol fixative and let entire quantity evaporate. To speed evaporation, tip slide after 5 minutes to drain excess fixative.
7. For best results, store/transport either at room temperature (20-30 degrees C) or refrigerated at 2 to 8 degrees C, and stain within 7 days of collection. If not stained within 7 days, fixed specimen should be stored at -20 degrees C.
Additional Information: Performance studies using the cytobrush on pregnant patients have not been conducted.
Specimen Type: Cervical (swab)
Container/Tube: Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Volume: Swab
Collection Instructions:
1. A Dacron swab should be used to sample pregnant patients or patients with a small cervical os.
2. Wipe exocervix with cotton or Dacron swab to remove excess mucus. Dispose of swab.
3. Insert large or small Dacron swab into endocervical canal until most of Dacron tip is not visible.
4. Rotate swab for 5 to 10 seconds inside endocervical canal.
5. Withdraw swab without touching any vaginal surfaces.
Specimen Type: Rectal (swab)
Container/Tube: Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Volume: Swab
Collection Instructions:
1. Specimen should be collected only from symptomatic patients.
2. Insert a large Dacron swab approximately 3 cm into anal canal.
3. Move swab from side to side to sample crypts.
4. Withdraw swab. If fecal contamination occurs, discard swab and obtain another specimen.
Specimen Type: Conjunctival (swab)
Container/Tube: Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Volume: Swab
Collection Instructions:
1. Specimen should be collected only from symptomatic patients.
2. Apply a topical proparacaine-based anesthetic to the eye or eyes (optional).
3. Using the small swab, thoroughly swab the inner surface of the lower, then upper eyelid. If samples are taken from both eyes, use the swab on the less affected eye first to avoid further contamination of that eye.
Specimen Type: Nasopharyngeal (swab or aspirate)
Container/Tube: Trinity Biotech MicroTrak Chlamydia trachomatis Specimen Collection Kit (Supply T176)
Specimen Volume: Swab
Collection Instructions:
1. Specimen should be collected only from symptomatic patients.
2. Collect specimen from the posterior nasopharynx by nasal swab or nasal aspirate using a standard collection method.
Slide preparation (nasal aspirate):
1. Vortex specimen gently to break up mucus.
2. Place 1 drop of the vortexed specimen on well. Cover entire well and stay within well perimeter.
3. Check coverage.
4. Allow specimen to completely air dry.
5. Lay slide flat; flood with 0.5 mL methanol fixative and let entire quantity evaporate. To speed evaporation, tip slide after 5 minutes to drain excess fixative.
6. For best results, store/transport either at room temperature (20-30 degrees C) or refrigerated at 2 to 8 degrees C, and stain within 7 days of collection. If not stained within 7 days, fixed specimen should be stored at -20 degrees C
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Ambient (preferred) | |
| Frozen | ||
| Refrigerated | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Chlamydia trachomatis is the most common cause of sexually transmitted disease in developed countries. Chlamydia is recognized as a cause of cervicitis, pelvic inflammatory disease, endometritis, perihepatitis, and urethral syndrome in females, nongonococcal urethritis, epididymitis, and proctitis in males. In females the infection is often asymptomatic; males are more frequently symptomatic. Transmission of Chlamydia trachomatis from pregnant females to infants is 1 of the major causes of infant pneumonia and conjunctivitis.
Because of the serious consequences associated with these infections, and the susceptibility of Chlamydia to antibiotics, laboratory diagnosis is important for the clinical management of patients. DNA-based assays are now available for the identification of Chlamydia trachomatis. However, these assays are currently not approved for use on all specimen types. The MicroTrak assay is an antibody-based method and is approved for use on rectal or nasopharyngeal specimens.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
None seen
Interpretation Provides information to assist in interpretation of the test results
This assay is positive in approximately 90% of infected cases when adequate specimen is submitted. The sensitivity is reduced when the specimen demonstrates few columnar/cuboidal cells.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Ocular and nasopharyngeal specimens are the only acceptable sites that can be tested on infants and children. Rectal, conjunctival, and nasopharyngeal specimens should be collected only from symptomatic patients.
Vaginal specimens are inferior to endocervical swabs.
The MicroTrak slides are not useful for detecting Chlamydia psittaci or Chlamydia pneumoniae.
Negative results from specimens with <10 columnar/cuboidal cells should be interpreted with caution.
In populations with low disease prevalance (5% or less), a positive MicroTrak result should be interpreted with caution.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Groseclose SL, Zaidi AA, DeLisle SJ, et al: Estimated incidence and prevalence of genital Chlamydia trachomatis infections in the United States, 1996. Sex Transmit Dis 1999;26:339-344
2. Guaschino S, De Seta F: Update on Chlamydia trachomatis. Ann NY Acad Sci 2000;900:293-300
Method Description Describes how the test is performed and provides a method-specific reference
Monoclonal antibodies have been prepared against the major outer membrane protein present in all 15 known human serovars of Chlamydia trachomatis and in both forms of the organism: the infectious elementary body, and the metabolically active, replicating reticulate body. The antibodies are labeled with fluorescein isothiocyanate. When the specimen is applied directly to a slide well and stained, the antibody conjugate binds specifically to any Chlamydia trachomatis present in the smear. A rinse step removes unbound antibody. When viewed under a fluorescence microscope, stained smears from Chlamydia-positive specimens contain apple-green elementary or reticulate bodies contrasted by the reddish-brown background of the counterstained cells.(Package insert: MicroTrak Chlamydia trachomatis Direct Specimen Test. Trinity Biotech, Jamestown, NY, July 2008)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 1st Shift
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87270
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| SRC15 | SOURCE: | 31208-2 |
| 11547 | Result: | 6355-2 |
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