Chlamydia and N. Gonorrhoeae Non-Culture by Amplified RNA Assay

MICHIGAN DEPARTMENT OF HEALTH AND HUMAN SERVICES

BUREAU OF LABORATORIES

Chlamydia and N. gonorrhoeae Non-culture

Rev. 3/2/2016

Chlamydia and N. gonorrhoeae Non-culture by Amplified RNA Assay

ANALYTES TESTED: Chlamydia trachomatis and Neisseria gonorrhoeae

USE OF TEST: Determination of Infection by Detection of Chlamydia and N. gonorrhoeae RNA

SPECIMEN COLLECTION AND SUBMISSION GUIDELINES:

Test Request Form DCH-1248

Specimen Submission Guidelines

Transport Temperature: Ambient temperature

SPECIMEN TYPE:

Specimen Required: Endocervical, urethral, throat, rectalor vaginal swab or urine.

Minimum Acceptable Volume: 2 ml for urine.

Container: Unisex swab collection kit for endocervical, throat, rectal, and male urethral specimens.

Vaginal swab collection kit for vaginal specimens.

Urine transport tube for urine specimens.

Shipping Unit: Unit 2 for endocervical, urethral, throat, or rectal swabs; Unit 2U for urine; and Unit 2V for vaginal swabs.

SPECIMEN REJECTION CRITERIA:

Critical Data Needed For Testing:

Patient name

Patient date of birth

Patient gender

Specimen source

Date collected

Submitting Agency

As a requirement for this testing funded by federal sources, it is expected the patients will be selectively screened and the reason for testing will be checked on the form.

TEST PERFORMED:

Methodology: GenProbe Aptima RNA Amplification

Turn Around Time: Typically tests are reported within one day of receipt. Specimens requiring follow up testing may take up to three working days.

Where/When Performed: Daily.

RESULT INTERPRETATION:

ReferenceRange: Not Applicable

A positive result indicates that Chlamydia / N. gonorrhoeae RNA is present in the sample and strongly supports a diagnosis of Chlamydia/Gonorrhoea infection.

FEES:

DCH 1248 (Michigan Regional Laboratories Test Requisition) – Chlamydia / N. gonorrhoeae

The current fee is $77.08 for a Chlamydiatrachomatisand Neisseria gonorrhoeae result. Medicaid or private insurance will be billed based on information provided with the requisition. If no billing information is provided, the submitter will be billed.

NOTES:

1. Submit specimens promptly to laboratory to decrease potential for equivocal results. Urines must be tested within 30 days of collection. Swabs must be tested within 60 days of collection.

2. Test performance has been validated on samples from patients attending STD, OB/GYN, FP and adolescent clinics.

3. Test-of-cure is not recommended as a routine procedure after therapy for C. trachomatis or N. gonorrhoeae infections with recommended treatment regimens. Non-culture tests should not be performed <4 weeks after completion of antimicrobial therapy because the presence of nonviable organisms may produce false-positive results. CDC recommends repeat testing of positive patients 3-6 months (up to one year) after treatment to assist in the identification of repeat infections.

ALIASES:

CT and GC