Purpose

This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 positive for BV, and samples with a score of 2 indeterminate for BV. Detect the presence of Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, Candida lusitaniae, and Candida krusei DNA in vaginal samples as an aid to the diagnosis of vulvovaginal candidiasis in symptomatic women. Also used in the diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections.

Collect

Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit

Specimen Preparation

Vaginal swab: Collect vaginal fluid sample using the Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Screw the cap on tightly.

Unacceptable Conditions

Incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen; specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs

Storage/Transport Temperature

Refrigerate

Stability (from collection to initiation)

Room temperature: 30 days
Refrigerated: 30 days
Frozen: Not Acceptable

Cerner Orderable(s)

Vaginosis DNA Plus Panel (SENDOUT)

Performed

Performed at LabCorp, test code: 180068

Methodology

Nucleic acid amplification (NAA)

Reported

3-4 days

Reference Interval

See Laboratory Report

CPT Codes

87481x4, 87491, 87512, 87591, 87798, 87799x3

Performing Lab

LabCorp Tampa
Collection

Purpose

This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 positive for BV, and samples with a score of 2 indeterminate for BV. Detect the presence of Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, Candida lusitaniae, and Candida krusei DNA in vaginal samples as an aid to the diagnosis of vulvovaginal candidiasis in symptomatic women. Also used in the diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections.

Collect

Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit

Specimen Preparation

Vaginal swab: Collect vaginal fluid sample using the Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Screw the cap on tightly.

Unacceptable Conditions

Incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen; specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs

Storage/Transport Temperature

Refrigerate

Stability (from collection to initiation)

Room temperature: 30 days
Refrigerated: 30 days
Frozen: Not Acceptable
Ordering

Cerner Orderable(s)

Vaginosis DNA Plus Panel (SENDOUT)

Performed

Performed at LabCorp, test code: 180068

Methodology

Nucleic acid amplification (NAA)

Reported

3-4 days
Result Interpretation

Reference Interval

See Laboratory Report
Administrative

CPT Codes

87481x4, 87491, 87512, 87591, 87798, 87799x3

Performing Lab

LabCorp Tampa