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Test Code LAB3358 GC/Chlamydia

Important Note

Not approved for patients <14 years of age. For those patients, use AOMC test code LAB7392. Please note AOMC collection instructions are different: Vaginal, Rectal, or Throat swab collected using the Xpert Swab Collection kit. Urine specimens are collected in a sterile cup.

Test Performed By

Cayuga Medical Center Main Laboratory

Container Name

Aptima Swab
PAP Vial
Urine

Day(s) and Time(s) Test Performed

Monday through Friday, days

Source

Vaginal, Endocervical, male urethral, urine, rectal (anal), throat (oral).

 

In-house test not approved for ocular or peritoneal fluid testing. Testing for those sources will be sent to a referral lab.

Specimen Collection Instructions

Submit only 1 of the following specimens:

 

Specimen Type: Endocervix/Cervix

Supplies: Aptima Unisex Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Unisex Swab Collection Kit.

2. Use cleaning swab (white shaft) to remove excess mucus from endocervix/cervix.

3. Discard the cleaning swab.

4. Insert second swab (blue shaft) 1 to 1.5 cm into endocervical canal and rotate swab gently for 30 seconds. Avoid touching vaginal wall when removing swab.

5. Place blue swab into transport tube provided in collection kit.

6. Snap off blue swab at score line so it fits into closed tube.

7. Cap tube securely, and label tube with patient's entire name and collection date and time.

 

 

Specimen Type:Vaginal

Supplies:Aptima Multitest Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.

2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

3. Place pink swab into transport tube provided in collection kit.

4. Snap off pink swab at score line so it fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name and collection date and time.

 

 

Specimen Type:Urethra (Males Only)

Supplies:Swab, Aptima Unisex Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Unisex Swab Collection Kit.

2. Patient should not have urinated for at least 1 hour prior to collection.

3. With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.

4. Once inserted, rotate blue swab gently at least 1 full rotation using sufficient pressure to ensure swab comes into contact with all urethral surfaces. Allow blue swab to remain inserted for 2 to 3 seconds.

5. Place blue swab in transport tube provided in collection kit.

6. Snap off blue swab at score line so it fits into closed tube.

7. Cap tube securely, and label tube with patient's entire name and collection date and time.

 

 

Specimen Type:Urine

Supplies:Aptima Urine Transport Tube

 

When collecting urine for GC/Chlamydia AND urinalysis/culture please collect the GC/Chlamydia urine first before any surface urethral cleaning is done. Collect a second clean catch urine specimen for the urinalysis/culture.

 

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to specimen collection.

2. Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.

3. Within 24 hours of collection, transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube.

4. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation.

 

 

Specimen Type:ThinPrep Specimen (Endocervix/Cervix)

Supplies:Aptima Specimen Transfer Kit

 

Collection Instructions:

1. Collect ThinPrep sample as per normal collection process.

 

 

Specimen Type:Oropharynx/Pharynx/Throat

Supplies:Aptima Multitest Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.

2. Swab site using Aptima Multitest Swab (pink shaft).

3. Place pink swab in transport tube provided in collection kit.

4. Snap off pink swab at score line so it fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name and collection date and time.

 

 

Specimen Type:Rectal/Anal

Supplies:Swab, Aptima Multitest Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.

2. Insert swab into rectum about 3 to 5 cm past anal margin and gently rotate swab for 10 seconds.

3. Place collection swab in transport tube provided in collection kit.

4. Snap off swab at score line so it fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name and collection date and time

 

Temperature and Specimen Stability

Aptima Swab - 60 days room temp or refrigerated, 12 months frozen

PAP Vial - 30 days room temp or refrigerated

Aptima Thin Prep Vial - 14 days room temp, 30 days refrigerated, 12 months frozen

Urine - unpreserved 24 hours room temp or refrigerated

Aptima Urine Vial - 30 days room temp or refrigerated, 12 months frozen

List Price

$323.40

CPT Codes

87491 | 87591

Methodology

Nucleic Acid Amplification 

Clinical and Interpretive

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections are two of the most common sexually transmitted infections worldwide. This assay may be used to test patient specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcus and/or chlamydial infection. The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae.

 

Chlamydiae are nonmotile, gram-negative, obligate intracellular bacteria. C. trachomatis can cause nongonococcal urethritis, epididymitis, proctitis, cervicitis, acute salpingitis, and Pelvic Inflammatory Disease (PID). C. trachomatis infections are often asymptomatic in both males and females. Children born to infected mothers are at significantly higher risk for inclusion conjunctivitis and chlamydial pneumonia.

 

N. gonorrhoeae is the causative agent of gonorrheal disease. N. gonorrhoeae are nonmotile, gram-negative diplococci. The majority of gonorrheal infections are uncomplicated lower genital tract infections and may be asymptomatic. However, if left untreated in women, infections can ascend and cause PID, which can manifest as endometritis, salpingitis, pelvic peritonitis, and tubo-ovarian abscesses. A smaller percentage of persons with gonococcal infections may develop Disseminated Gonococcal Infection (DGI). When left untreated in men, urethritis including dysuria, epididymitis, and scrotal pain may persist.

 

CT and NG oropharyngeal infections may present with sore throat although most are asymptomatic.

 

Rectal infections, when symptomatic, may present with discharge, anal itching, soreness, bleeding, and painful bowel movements.