TEM-PCR Testing for Women

TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) technology is a unique, multiplex amplification platform designed to overcome the challenges that exist with conventional laboratory methods and real-time PCR applications.

TEM-PCR Distinctions:

• 1 or 2 day results, depending on location
• Detects bacteria in the presence of antibiotics
• Differentiates pathogens that present with similar symptoms
• Simultaneously identifies viral and bacterial pathogens
• Identifies difficult to culture pathogens
• Offers simplicity of single sample collection
• Uses specimen adequacy control to eliminate false negatives

Improved speed and accuracy of laboratory results lead to:

• Improved patient outcomes
• Cost reduction and avoidance
• Reduced antibiotic utilization
• Increased patient satisfaction
• Greater clinical value

15:1 Women’s Health Panel

Test Code: 95198
CPT Codes: 87511, 87798 x4, 87481 x5, 87491, 87591, 87661, 87529x2

• Atopobium vaginae
• Candida albicans
• Candida glabrata
• Candida Krusei
• Candida parapsilosis
• Candida tropicalis
• Chlamydia trachomatis
• Gardnerella vaginalis
• Herpes Simplex Virus Types 1 & 2
• Mycoplasma hominis
• Mycoplasma genitalium
• Neisseria gonorrhoeae
• Trichomonas vaginalis
• Ureaplasma urealyticum

Bacterial Vaginosis Panel

Test Code: 95176
CPT Codes: 87511, 87798 x4

• Atopobium vaginae
• Gardnerella vaginalis
• Mycoplasma genitalium
• Mycoplasma hominis
• Ureaplasma urealyticum

Candidiasis Panel

Test Code: 95621
CPT Code 87481 x5

• Candida albicans
• Candida glabrata
• Candida Krusei
• Candida parapsilosis
• Candida tropicalis

STD 5 Panel

Test Code: 95848
CPT Codes: 87491, 87591, 87661, 87529x2

• Chlamydia trachomatis
• Herpes Simplex Virus 1
• Herpes Simplex Virus 2
• Neisseria gonorrhoeae
• Trichomonas vaginalis

Medical records must be provided with specimen to support diagnosis code for test(s) ordered.

TEM-PCR Women’s Health Collection Guide

ThinPrep with brush and spatula - Supply #: C01
ThinPrep with broom - Supply #: C02

ThinPrep^® Pap Solution Specimen Collection

1. Collect specimen as directed according to ThinPrep Specimen Collection instructions located on DLO’s Virtual Test Guide.
2. When ordering test using EMR, input the test codes as listed on the facing page. When ordering through a manual Cytology requisition, write the desired test code in the “Comments” space located at the bottom.
3. Prepare specimen for transport according to ThinPrep Specimen Collection instructions.

NOTE: Because certain organisms are intracellular, there must be enough human cells present to detect the organism. Diatherix tests the specimen for human DNA to ensure that an adequate number of cells are present for a valid result.

ThinPrep pap solution is stable for TEM-PCR testing for 30 days.

Universal Collection Kit for Panels for Women and Men - Supply #: K144

The swab or urine specimen for TEM-PCR Panels for Women and Men must be collected using a Universal Collection Kit containing a vaginal/urethral/endocervical swab, a transfer pipette for urine specimens and an orange top transport tube.

Please read instructions thoroughly before collection.

Clinical presentation must dictate collection technique.

Endocervical Swab Collection

1. Open the Universal Collection Kit and discard the plastic disposable pipette. Remove the endocervical swab from the wrapper being careful not to contaminate the swab by touching it to any surface.
2. Insert the white tip of the specimen swab into the endocervical canal.
3. Gently rotate the swab for 15 seconds to ensure adequate sampling.
4. Withdraw the swab carefully.
5. Handle the cap and tube carefully to avoid contamination.
6. Without contaminating the swab, place the swab in the white top transport tube all the way to the bottom of the tube. Rotate the swab 5 times in the solution and carefully break the swab at the scored line on the shaft or you may discard the swab in a manner consistent with the practices set out by the physician’s office or clinic.
7. Recap the transport tube carefully. Ensure the cap seals tightly.
8. Label the transport tube with the patient name and date collected.

NOTE: Because certain organisms are intracellular, there must be enough human cells present to detect the organism. Diatherix tests the specimen for human DNA to ensure that an adequate number of cells are present for a valid result.

Urine Specimen

1. A “dirty urine” catch, which incorporates the contents of the urethra as well as the “wash-off” of the labia and vaginal introitis, is desired. The patient should not have urinated for at least one hour prior to sample collection.
2. First morning specimen is preferred. Do not use any wipes to cleanse the external genital surfaces before collecting the specimen.
3. Open the Universal Collection Kit and discard the collection swab.
4. Using a sterile, plastic, preservative-free specimen collection container, the patient should collect the first 5-10 mL of voided urine (the first part of the stream).
5. Unscrew the white top transport tube cap, taking care not to spill the transport buffer. Handle the cap and tube carefully to avoid contamination.
6. Use the plastic transfer pipette to transfer 1 mL of urine from the collection cup into the transport tube. Do NOT overfill.
7. Recap the transport tube carefully. Ensure the cap seals tightly.
8. Label the transport tube with the patient name and date collected. Take care not to obscure the fill window on the transport tube.

Vaginal Swab Collection

1. A vaginal swab is the appropriate specimen if a characteristic discharge is present. When ulcerations suggestive of Herpes are seen, careful attention should be given to swabbing the base of the ulceration as well as collecting any secretions that are present and representative of the patient’s symptoms.
2. Open the Universal Collection Kit and discard the plastic disposable pipette. Remove the swab from the wrapper being careful not to contaminate the swab by touching it to any surface.
3. Insert the tip of the specimen swab about two inches (5 cm) into the opening of the vagina.
4. Gently rotate the swab for 15 to 30 seconds against the sides of the vagina to ensure adequate sampling.
5. Withdraw the swab carefully.
6. Handle the cap and tube carefully to avoid contamination.
7. Without contaminating the swab, place the swab in the white top transport tube all the way to the bottom of the tube. Rotate the swab 5 times in the solution and carefully break the swab at the scored line on the shaft or you may discard the swab in a manner consistent with the practices set out by the physician’s office or clinic.
8. Recap the transport tube carefully. Ensure the cap seals tightly.
9. Label the transport tube with the patient name and date collected.

NOTE: Because certain organisms are intracellular, there must be enough human cells present to detect the organism. Diatherix tests the specimen for human DNA to ensure that an adequate number of cells are present for a valid result.

DLO is the exclusive provider of TEM-PCR testing to Oklahoma physicians through Diatherix Laboratories, LLC. Diatherix is an innovative, CAP-accredited molecular diagnostic laboratory utilizing proprietary TEM-PCR technology for precise detection of infectious disease — linking diagnostics to therapeutics.

Diagnostic Laboratory of Oklahoma (DLO) strives to empower patients to take a more active role in their healthcare decisions through providing education on disease states and available diagnostic testing, as well as resources for additional information from medical organizations.