Chlamydia & Gonorrhea Nucleic Acid Amplification Test

Brief Description

Specimens are screened by the Aptima Combo-2 target amplification nucleic acid probe test that utilizes target capture for in vitro qualitative detection and differentiation of ribosomal Ribonucleic acid (RNA) (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae.

Laboratory Unit

• Virology GPHL
• Bacteriology WPHL

Methodology

Nucleic acid amplification test (NAAT), combines the technologies of Target capture, Transcription-Mediated Amplification (TMA) and Dual Kinetic assay (DKA).

Specimen Collection

• Vaginal Swab:
  • Use only the Hologic Aptima specimen collection swab to collect the specimen.
• Endocervical Swab:
  • Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. Use only the Hologic Aptima specimen collection swab (blue shaft swab in unisex collection kit; pink shaft swab) in multitest collection kit to collect the specimen. 
• Male Urethral Swab:
  • The patient should not have urinated for at least 1 hour prior to sample collection. Use only the Hologic Aptima specimen collection swab to collect the specimen. 
• Male Penile Meatal Swab:
  • Specimen must be assayed within 60 days of collection. Immediately place the Hologic Aptima specimen collection swab into the specimen transport tube. 
• Urine:
  • Specimen must be assayed within 30 days of collection. The patient should not have urinated for at least one hour prior to specimen collection. Provide first catch urine (approximately 20 to 30 ml of the initial urine stream) into a urine collection cup. Female patients should not cleanse the labial area prior to providing the specimen. Transfer 2 mL of urine into the Hologic Aptima urine specimen transport tube within 24 hours of collection. 
• Rectal Swab:
  • Immediately place the Hologic Aptima specimen collection swab into the specimen transport tube. 
• Pharyngeal Swab:
  • Immediately place the Hologic Aptima specimen collection swab into the specimen transport tube.

Storage/Transport

• Urogenital swab specimens:
  • Store specimens at ambient temperature (2-30 °C) prior to shipment. Specimens should be shipped daily or next working day using the ambient (2-30 °C) specimen outfit. If longer storage is needed, freeze specimens in the swab specimen transport tube within 7 days of collection at frozen (-20°C or colder) to allow testing up to 12 months after collection. Must be received within 60 days of collection.
• Extragenital swab specimens (throat and rectal):
  • Store specimens at (4-30 °C) or frozen (-20 °C or colder). Must be received within 60 days of collection.
• Urine:
  • Transport to the lab in the primary collection container or the transport tube at ambient temperature (2-30 °C). If longer storage is needed, freeze specimens in the swab specimen transport tube within 7 days of collection at frozen (-20°C or colder) to allow testing up to 12 months after collection. Must be received within 60 days of collection.
• FRM-QA 4 Refrigeration Outfit Guide

Acceptable Specimen Type(s)

• Aptima Unisex Swab Specimen Collection kit: clinician collected vaginal, urethral, endocervical, pharyngeal, and rectal swabs
• Aptima Multitest Swab Specimen Collection kit: clinician collected vaginal, pharyngeal and rectal swabs
• Aptima Urine Specimen Collection kit: urine

Test Request

• GPHL Apollo Web Portal
• Web Portal Instructions
• For manual orders, download the GPHL Submission Form

Possible Results

• Negative
• Positive
• Indeterminate
• Unsatisfactory

Reference Range

Negative

Unacceptable Conditions

• Missing written testing requisition
• Missing minimum of 2 patient identifiers
• Unidentified specimen
• No name on specimen
• Improper storage/transport of specimen
• No Swab in Collection Device (excluding urine) or 2 Swabs Present
• Improper labeling
• Low volume samples
• Urine Collection Device Too Full (must fall between the two black indicator lines)
• Specimen type collected in outfit other than those listed in acceptable specimen outfits and types
• Receipt of Swabs > 60 Days after Collection Date
• Receipt of Urines > 30 Days after Collection Date
• Medical/Legal test requested (APTIMA Combo 2 is not intended for medical/legal cases)
• Specimen damaged, broken, or leaking upon arrival
• Turbid or contaminated specimens
• Swab other than the specimen collection swab provided in the acceptable specimen outfit kits
• Patient name/identifier on specimen does not match requisition
• Expired collection outfit
• Incorrect or missing collection date on requisition
• Specimens collected from patients less than 16 years of age

Interfering Substances

Patient on antibiotic therapy, 10% blood in swab specimens, 30% blood in urine specimens.

Result Reported

• 3-5 business days GPHL
• 1-3 business days WPHL

Fees

Fee schedule

LOINC/Order Codes

64017-7 (Order code: 1060 Decatur, W10000 Waycross)