Vaginitis and Vaginosis Plus Chlamydia and Gonorrhoeae, (TMA)

CPT Code(s)

87481 Candida, DNA PCR (x2), 81513 DS Bacterial Vaginosis RNA, 87661 Trichomonas Vaginalis Amplified Probe, 87491 Chlamydia DNA PCR, 87591 GC DNA PCR

Synonym(s)

CT-GC-VAG

Performed

Molecular Diagnostics Laboratory

Clinical Indication and Relevance

Bacterial vaginosis (BV): The assay is useful to detect bacteria that have been associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii) from clinician or patient-collected vaginal swab specimens in an Aptima Multitest Transport Swab.
Candida Vaginitis (CV)/ Trichomonas vaginalis (TV): The assay is useful to detect microorganisms that have been associated with vulvovaginal candidiasis (candida vaginitis CV) and trichomoniasis (Trichomonas vaginalis, TV), including Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Trichomonas vaginalis from clinician or patient-collected vaginal swab specimens in an Aptima Multitest Transport Swab.
The assay is useful to detect Chlamydia trachomatis from vaginal, penile meatal, rectal, throat (pharyngeal), endocervical, male urethral and urine samples.
The assay is useful to detect Neisseria gonorrhoeae from vaginal, penile meatal, rectal, throat (pharyngeal), endocervical, male urethral, and urine samples.

Methodology

The assay uses transcription mediated amplification (TMA) on the Hologic Panther System.

Panel/Profile Components

Bacterial Vaginosis (BV), Candida Vaginitis (CV)/ Trichomonas vaginalis (TV), Chlamydia trachomatis (CT)/ Neisseria gonorrhoeae (GC).

Specimen Collection / Handling Requirements

Sample Type: 

Aptima Multitest Swab Collection Kit

Specimen Labeling:

The specimen must be labeled with two identifiers at the time of collection. Examples of acceptable identifiers include but are not limited to patient name, date of birth, hospital medical record number, accession number. A location (e.g., hospital room number) is not an acceptable identifier. Collection date and collector’s identifier are required.

A completed requisition form should be submitted with every sample, and at minimum, the following is required: ordering physician name, phone number, fax number, and patient’s name, identifying number of patients, patient sex, patient date of birth specimen type, collection date, tests requested, provisional diagnosis or clinical rationale for test, and billing information.

Minimum Specimen Requirements

Transport:

Specimens can contain high levels of organisms.  Specimens must be shipped and transported in accordance with applicable local, national, and international transportation regulations.  Maintain proper storage conditions of 2-8°C during shipping to ensure integrity of the specimen.

Stability:

Aptima Multitest Swab Collection Kit:  After collection, transport and store the transport tube at 2-30°C up to 60 days after collection.

Unacceptable Samples: 

Improperly labeled or incorrect patient identification, specimen leaked,
incorrect media, specimen transport tube with no swab or two swabs, a cleaning swab or a swab not supplied by Hologic.

Turnaround time

1-3 Business Days.

View Requisition Sheet