Molecular Laboratory

• Specimen Types accepted: Clinician collected endocervical, vaginal, or male urethral swab* specimens, male urine, Clinician collected PreservCyt Solution liquid PAP specimens.
  • *Swabs must be collected with the Aptima Unisex purple or Aptima Multi-test specimen collection kits.
• Sample storage prior to testing:
  • Swabs: 2-30^oC for 60 days, -20^oC – -70^oC for 12 months
  • Urine: in primary container 2-30^oC for 24 hours, in urine Aptima transport tube 2-30^oC for 30 days.
  • PAP: 2-30^oC for 30 days
• Unacceptable Specimens/Rejection Criteria: Aptima tube received with no swab, two swabs, a cleaning swab, or a swab not supplied by Hologic; samples not maintained at proper storage temperatures.
• Reference Values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: in vitro target amplification nucleic acid probe test for qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)
• Days testing performed: Monday – Friday
• Expected turnaround time: 4 business days

• Specimen types accepted: Clinician-collected swab specimens from anogenital or non-genital lesions placed in STM or VTM (Aptima Multi-test, UTM-RT, Remel M4RT, Remel M4, Remel M5)
• Sample storage prior to testing: 2-30^oC for 36 days for swabs collected in Aptima Multi-test Tube, 2-25^oC for up to 48 hours for samples collected in UTM before being placed in STM or VTM.
• Unacceptable specimens/rejection criteria: any specimen that do not meet the types or sample storage requirements listed above.
  • Reference values: Positive (organism detected)
  • Negative (organism not detected)
• Methodology: In vitro diagnostic nucleic acid amplification test (NAAT) for the qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2)
• Days testing performed: Monday – Friday
• Expected turnaround time: 4 business days

• Specimen types accepted: Clinician collected PreservCyt Solution liquid PAP specimens
• Sample storage prior to testing: 2-30^oC for 30 days, 2-8^oC for 105 days
• Unacceptable specimens/rejection criteria: Specimen not received in PreservCyt Solution
• Reference values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 HR HPV in cervical specimens.
• Days testing performed: Monday – Friday
• Expected turnaround time: 7 business days

• Specimen types accepted: Clinician collected PreservCyt Solution liquid PAP specimens
• Sample storage prior to testing: 2-30^oC for 30 days, 2-8^oC for 105 days
• Unacceptable specimens/rejection criteria: Specimen not received in PreservCyt Solution
• Reference values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: In vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 & 45 in cervical specimens from women with APTIMA HPV Assay positive result
• Days testing performed: Monday – Friday
• Expected turnaround time: 7 business days

• Specimen Types accepted: Clinician collected endocervical, vaginal, or male urethral swab* specimens, male urine, Clinician collected PreservCyt Solution liquid PAP specimens.
  • *Swabs must be collected with the Aptima Unisex purple or Aptima Multi-test specimen collection kits.
• Sample storage prior to testing:
  • Swabs: 2-30^oC for 60 days, -20^oC – -70^oC for 12 months
  • Urine: in primary container 2-30^oC for up to 24 hours, in urine Aptima transport tube 2-30^oC for 30 days
• Unacceptable Specimens/Rejection Criteria: Aptima tube received with no swab, two swabs, a cleaning swab, or a swab not supplied by Hologic; samples not maintained at proper storage temperatures.
• Reference Values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: In vitro nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium
• Days testing performed: Monday – Friday
• Expected turn around time: 4 days

• Specimen Types accepted: Clinician collected endocervical, vaginal, or male urethral swab* specimens, male urine, Clinician collected PreservCyt Solution liquid PAP specimens.
  • *Swabs must be collected with the Aptima Unisex purple or Aptima Multi-test specimen collection kits.
• Sample storage prior to testing:
  • Swabs: 2-30^oC for 60 days, -20^oC – -70^oC for 12 months
  • Urine: in primary container 2-30^oC for up to 24 hours, in urine Aptima transport tube 2-30^oC for 30 days
  • PAP: 2-30^oC for 30 days
• Unacceptable Specimens/Rejection Criteria: Aptima tube received with no swab, two swabs, a cleaning swab, or a swab not supplied by Hologic; samples not maintained at proper storage temperatures.
• Reference Values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: In vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis
• Days testing performed: Monday – Friday
• Expected turnaround time: 4 days

• Specimen types accepted: Vaginal swab collected with the Aptima Multitest Swab specimen collection kit.
• Sample storage prior to testing: 2-30oC for 30 days, -20^oC – -70^oC for 90 days
• Unacceptable specimens/rejection criteria: swabs not collected into the Aptima Multitest Swab specimen collection kit, swabs not collected from the vagina.
• Reference values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms.
• Days testing performed: Monday – Friday
• Expected turnaround time: 4 business days

• Specimen types accepted: Vaginal swab collected with the Aptima Multitest Swab specimen collection kit.
• Sample storage prior to testing: 2-30oC for 30 days, -20^oC – -70^oC for 90 days
• Unacceptable specimens/rejection criteria: swabs not collected into the Aptima Multitest Swab specimen collection kit, swabs not collected from the vagina.
• Reference values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time transcription-mediated amplification (TMA) to detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, and Trichomonas vaginalis. The assay differentiates between Candida glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse P ribonucleoprotein; the assay does not differentiate among C spp. For Trichomonas vaginalis, the assay targets ribosomal RNA (rRNA) and differentiates the result from results for Candida glabrata and C spp.
• Days testing performed: Monday – Friday
• Expected turnaround time: 4 business days

• Specimen types accepted: Nasopharyngeal or Oropharyngeal swab collected with the Aptima Multitest swab collection kit, or put into VTM (Remel M4, M4RT, M5 or M6), Copan Universal Transport medium, BD Universal Viral transport medium
• Sample storage prior to testing: Multi-test: 2-30°C (6 days), VTM/UTM: 2-8°C (96 hours)
• Unacceptable specimens/rejection criteria: specimen sent at room temperature, swab in saline or PBS, swabs collected from sources other than nasopharyngeal or oropharyngeal, cotton swabs with wooden shaft
• Reference values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: T Nucleic acid amplification diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2
• Days testing performed: Monday – Friday
• Expected turnaround time: 1-2 business days

• Specimen types accepted: cardiac biopsy tissue placed in sterile TE buffered solution or sterile normal saline.
• Sample storage prior to testing: store at 2^oC to 8^oC upon receipt and until extraction.
• Unacceptable specimens/rejection criteria: tissue not placed in sterile TE buffered solution or sterile normal saline, non-cardiac tissue.
• Reference values:
  • Positive (organism detected)
  • Negative (organism not detected)
• Methodology: In vitro nucleic acid amplification test for the qualitative detection of DNA or RNA molecules from 12 infectious pathogens that are commonly involved in pathophysiological process of acute non-ischemic cardiomyopathy.
• Days testing performed: Monday – Friday
• Expected turnaround time: 4 business days

• Specimen types accepted: FFPE Blocks, FFPE Slides
  • If slides are sent, 20 unstained slides are needed and 1 H&E. There should be at least 20% tumor content.
• Sample storage prior to testing: room temperature
• Unacceptable specimens/rejection criteria: tissue samples with not enough residual tumor present
• Methodology: Oncomine Precision Assay GX
• Days testing performed: Monday – Friday
• Expected turnaround time: 2 weeks

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▪ The assay covers a panel of 50 genes, including 45 genes with hotspot mutations, 14 genes focusing on CNV gains or loss, and 18 fusion drivers. Please see table below:

▪ Capable of detecting 2,279 unique variants, emphasizing those of significant clinical importance (actionable mutations).

▪ The assay covers actionable somatic mutations. Please see table below for genes somatic mutations and indication that is covered by the assay.