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TEM-PCR Women's 15:1 Health Panel

Supply #K144 - TEM-PCR Universal Kit
Supply #C01 - ThinPrep w/Brush/Spatula

Test Code: 95198

Pathogens Detected: Atopobium vaginae, Candida Albicans, Candida Glabrata, Candida Parapsilosis, Candida tropicalis, Chlamydia trachomatis, Gardnerella vaginalis, Herpes Simplex Virus Types 1&2, Mycoplasma hominis, Mycoplasma genitalium, Neisseria gonorrhoeae, Trichomonas vaginalis, Ureaplasma urealyticum

TEM-PCR technology is a unique, multiplex amplification platform designed to overcome the challenges that exist with conventional laboratory methods and real-time PCR applications. 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

Disclaimer: The Diatherix Laboratories Sexually Transmitted Disease Panels are not recommended for evaluation of suspected sexual abuse or for other medico-legal indications

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.

Preferred Specimen: Clinical presentation must dictate collection technique.
Dirty Urine Collection
Endocervical Collection
Vaginal Collection

Collection Guide: 

Supply: K144 - TEM-PCR Universal Collection Kit or Supply #C01 - ThinPrep w/Brush/Spatula

Preferred Specimen: Universal Collection Kit containing a swab, a transfer pipette for urine specimens and a transport tube.

Please read instructions thoroughly before collection. Clinical presentation must dictate collection technique.

ENDOCERVICAL SWAB COLLECTION

  1. The swab for Women's Health Panel must be collected using a Universal Collection Kit containing a swab, a transfer pipette for urine specimens and a transport tube. Please read instructions thoroughly before collection. Clinical presentation must dictate collection technique.
  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 white tip of the specimen swab into the endocervical canal.
  4. Gently rotate the swab for 15 seconds 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 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.
  8. Recap the transport tube carefully. Ensure the cap seals tightly.
  9. Label the transport tube with the patient name and date collected.

URINE SPECIMEN COLLECTION

  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. First morning specimen is preferred. Do not use any wipes to cleanse the external genital surfaces before collecting the specimen.
  2. Open the Universal Collection Kit and discard the collection swab.
  3. 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).
  4. Unscrew the transport tube cap, taking care not to spill the transport buffer. Handle the cap and tube carefully to avoid contamination.
  5. Use the plastic transfer pipette to transfer 1 mL of urine from the collection cup into the transport tube. Do NOT overfill.
  6. Recap the transport tube carefully. Ensure the cap seals tightly.
  7. Label the transport tube with the patient name and date collected. Take care not to obscure the fill window on the transport tube.

VAGINAL SPECIMEN 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 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

REQUIREMENTS FOR ACCEPTANCE OF SPECIMEN

Specimens must be
  • appropriate for the test requested
  • accompanied by a properly completed, legible Diatherix Laboratory Requesition
  • transported to the lab according to packaging and shipping instructions
  • in a properly sealed biohazard specimen bag
  • labeled with two identifiers*, preferably with the patient’s name and barcode label which matches the requisition
  • intact, in the proper container and not leaking
  • in the appropriate specimen transport media
  • within the specimen transport stability range of 5 days, at ambient temperature, measured from time of collection to the time of receipt for laboratory testing.

Results: Are typically reported the same day Diatherix laboratory receives the specimen.

Rejection Criteria:

  • Loose top on the tube.
  • Specimen transfer tube labeled incorrectly
  • Incomplete requisition.
  • Incorrect packaging and shipping

*Other examples of acceptable identifiers include: date of birth, hospital number, social security number, unique random number. Each of the two identifiers must match on the tube and the requisition.

For additional supply or collection device information, please contact DLO's Customer Service at (800) 891-2917, option 2.

 

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