STD PCR assay, Chlamydia/GC Nucleic acid amplification test (NAAT)

Qualitative Target Amplification Nucleic Acid Probe

Test performed Monday – Friday, results within 3-4d

Male urethral, endocervical, rectal, throat, urine, and vaginal

Collection kits available from NPHL Client Services

Male urethral, endocervical, rectal, and throat use the APTIMA Unisex Swab Specimen Collection Kit; vaginal use the APTIMA Vaginal Swab Specimen Collection Kit; urine use the APTIMA Urine Specimen Collection Kit for male and female.
Collection:
Urethral male - (Discard large cleaning swab - not needed) Insert the specimen collection swab (blue shaft) 2-4 cm into the urethra. Rotate for 2-3 seconds. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label.
Endocervical - With large cleaning swab (white shaft) remove excess mucus and blood and discard. Insert the specimen collection swab (blue shaft) into the cervical canal and rotate for 10-30 seconds. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label.
Rectal swab - (Discard large cleaning swab - not needed) Insert the specimen collection swab (blue shaft) into the anal canal and rotate for 15-30 seconds. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label.
Throat swab - Discard large cleaning swab - not needed) Using the specimen collection swab (blue shaft) instruct patient to tilt head backwards, open mouth and say "ah." A tongue depressor may be used to depress the tongue and facilitate visualization of pharynx. Insert swab without touching lips, teeth, tongue, or cheeks.  Gently and quickly swab the tonsillar area side to side, making contact with inflamed or purulent sites. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label.
URINE – Use APTIMA® Urine Specimen Collection Kit for Male and Female Urine Specimens: Patient should NOT urinate for at least 1 hour prior to collection of specimens. Patient should collect the 20-30 ml of the initial urine stream in a sterile preservative-free collection cup. Transfer 2 mL of urine into the urine specimen transport tube within 24 hours of collection using pipette provided. Urine level should fall between the black fill lines on the transport tube label. Make sure cap is tightly secured to eliminate leaking. Recap and Label.
Vaginal swab - Use APTIMA® Vaginal Swab Specimen Collection Kit: Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line.  Do not hold the swab shaft below the score line.  Insert the specimen collection swab (pink shaft) into the vagina about two inches past the introitus and rotate for 10-30 seconds making sure swab touches the walls of the vagina. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label.
Specimen Labeling: Test subject to CLIA regulations and required 2 patient identifiers and source location on specimen container and requisition forms

1 swab or 20 - 30mL urine

Prior to and during shipment: Ambient 15-25°C up to 30 days

Shipping instructions, including specimen-handling requirements during transport:  Seal screw-top tubes with Parafilm™ or tape and place in biohazard bag with absorbent material.

Place specimen inside leak proof secondary container (biohazard bag and if transporting by air, use Tyvek™ Envelope) with adsorbent material. The secondary container must be packed inside an approved Category B shipping container.  Position NUlirt packing list or NPHL Test Order form between secondary container and box lid. Seal with tape.  Label outer box as UN3373 Category B, Biological Substance. Transport by NPHL ground courier. If courier not available, ship by FedEx, UPS, or USPS (1st Class, Priority or Express Mail). Follow appropriate DOT/IATA Regulation Guidelines.  For assistance, call NPHL State Training Coordinator at (402) 559-3590.
See instructions and shipping address: http://nphl.org/

NUlirt packing list or appropriate paperwork (completed in entirety) must accompany specimens.

Use only APTIMA® swab collection Specimen Collection Kits. Unacceptable specimens include wooden swabs, eye, and swab specimens without a swab in transport media. Large white swab is for preparatory cleaning of the endocervix and is unacceptable for testing

In APTIMA® transport media: Ambient 15-25°C: 30 days; Refrigerated: 30 days; Frozen: 90 days. Unpreserved urine specimens are stable at ambient for 24 hours

Negative for C. trachomatis / N. gonorrhoeae
Positive for C. trachomatis / N. gonorrhoeae
Positive for N. gonorrhoeae
Positive for C. trachomatis

Report positive C. trachomatis or N. gonorrhoeae results within 7 days to local or state health department.  Refer to Nebraska DHHS Title 173, Communicable Diseases.

A negative result does not preclude the presence of a C. trachomatis or N. gonorrhoeae infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient rRNA to be detected. Test results may be affected by improper specimen collection, improper specimen storage, technical error, or specimen mix-up.  

The positive predictive value of the test varies depending on the organism prevalence in the population, the gender of the patient and the specimen type tested.  According to CDC guidelines, positive screening tests should be considered presumptive evidence of infection.  Test results are reported as positive, negative or indeterminate. If an indeterminate result is reported then submit a new specimen if indicated or treat patient based on clinical judgment.

Culture is recommended as the standard for detection in suspected sexual abuse and for suspected failure of therapy. 

NUlirt packing list or appropriate paperwork (completed in entirety) must accompany specimens