Poudre Valley Hospital
Medical Center of the Rockies
Greeley Hospital
Collect
Only use the Cepheid Xpert Swab Collection Kit. Obtain swab kits from the microbiology department if needed.
Any other swab (Eswab, etc) is not acceptable and will be rejected and require re-collection.
Both clinician-collect and patient self-collect in a clinical setting are acceptable.
Open the Cepheid Xpert Swab Collection Kit. There will be two packages inside.
Discard the package with the LARGE swab into regular trash.
Keep the package with the pink capped tube and smaller swab for collection.
Collect the sample following manufacturer’s instructions (see link at bottom of page), then place swab into the pink capped vial and break off at score mark.
Securely cap, apply patient label with two identifiers, and send to laboratory as soon as possible.
See link to manufacturer’s complete collection instructions HERE.
Unacceptable Conditions
Culturette Swabs
Eswabs
Swabs collected on males
Large cleaning swab instead of collections swab
Storage/Transport Temperature
Ambient
Refrigerated
Stability (from collection to initiation)
42 days maximum
Performed
Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Harmony Lab- Monday-Friday 5:00am-10:00pm, Saturday-Sunday 5:00am-7:30pm
Greeley Hospital- all hours, 7 days/week
Remarks
Technical Bulletin from Cepheid can be found HERE on why Gardnerella vaginalis nor Lactobacillus species are included on the panel.
Performed
Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Harmony Lab- Monday-Friday 5:00am-10:00pm, Saturday-Sunday 5:00am-7:30pm
Greeley Hospital- all hours, 7 days/week
Methodology
Cepheid GeneXpert, RT-PCR
Synonyms
Vaginosis Panel
Epic ID
LAB2830
Interpretive Data
Interpretation:
For Bacterial vaginosis--
Positive = DNA targets related to bacterial vaginosis organisms detected
Negative = No DNA targets related to bacterial vaginosis organisms were detected
For Candida group, Candida glabrata/krusei, Trichomonas vaginalis--
Not detected = Absence of organism DNA
Detected = Presence of organism DNA
Methodology:
This assay employs real-time PCR amplification for the detection of DNA targets from anaerobic bacteria (Atopobium spp, Megasphaera-1, Bacterial Vaginosis Associated Bacteria 2), associated with bacterial vaginosis, Candida species (C. albicans, C. tropicalis, C. dubliniensis, C. parapsilosis) associated with vulvovaginal candidiasis, and Trichomonas vaginalis, the causative agent of trichomoniasis. Both clinician-collected and self-collected vaginal swabs (collected in a clinical setting) showed equivalent sensitivity and specificity, and can be tested on patients who are symptomatic for vaginitis/vaginosis. A "Detected" result should be coupled with clinical indicators for diagnosis. A "Not detected" result for this assay does not exclude bacterial or yeast involvement in a disease process. This assay has been approved by the U.S. Food and Drug Administration for testing vaginal specimens collected using the Cepheid Xpert Swab Collection Kit. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.
CPT Codes
87801 – Bacterial Vaginosis
87481 – Candida group
87481 – Candida glabrata/krusei
87661 – Trichomonas vaginalis
Collection
Epic ID
LAB2830
Performing Lab
Poudre Valley Hospital
Medical Center of the Rockies
Greeley Hospital
Collect
Only use the Cepheid Xpert Swab Collection Kit. Obtain swab kits from the microbiology department if needed.
Any other swab (Eswab, etc) is not acceptable and will be rejected and require re-collection.
Both clinician-collect and patient self-collect in a clinical setting are acceptable.
Open the Cepheid Xpert Swab Collection Kit. There will be two packages inside.
Discard the package with the LARGE swab into regular trash.
Keep the package with the pink capped tube and smaller swab for collection.
Collect the sample following manufacturer’s instructions (see link at bottom of page), then place swab into the pink capped vial and break off at score mark.
Securely cap, apply patient label with two identifiers, and send to laboratory as soon as possible.
See link to manufacturer’s complete collection instructions HERE.
Unacceptable Conditions
Culturette Swabs
Eswabs
Swabs collected on males
Large cleaning swab instead of collections swab
Storage/Transport Temperature
Ambient
Refrigerated
Stability (from collection to initiation)
42 days maximum
Performed
Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Harmony Lab- Monday-Friday 5:00am-10:00pm, Saturday-Sunday 5:00am-7:30pm
Greeley Hospital- all hours, 7 days/week
Remarks
Technical Bulletin from Cepheid can be found HERE on why Gardnerella vaginalis nor Lactobacillus species are included on the panel.
Ordering
Performed
Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Harmony Lab- Monday-Friday 5:00am-10:00pm, Saturday-Sunday 5:00am-7:30pm
Greeley Hospital- all hours, 7 days/week
Methodology
Cepheid GeneXpert, RT-PCR
Synonyms
Vaginosis Panel
Epic ID
LAB2830
Result Interpretation
Interpretive Data
Interpretation:
For Bacterial vaginosis--
Positive = DNA targets related to bacterial vaginosis organisms detected
Negative = No DNA targets related to bacterial vaginosis organisms were detected
For Candida group, Candida glabrata/krusei, Trichomonas vaginalis--
Not detected = Absence of organism DNA
Detected = Presence of organism DNA
Methodology:
This assay employs real-time PCR amplification for the detection of DNA targets from anaerobic bacteria (Atopobium spp, Megasphaera-1, Bacterial Vaginosis Associated Bacteria 2), associated with bacterial vaginosis, Candida species (C. albicans, C. tropicalis, C. dubliniensis, C. parapsilosis) associated with vulvovaginal candidiasis, and Trichomonas vaginalis, the causative agent of trichomoniasis. Both clinician-collected and self-collected vaginal swabs (collected in a clinical setting) showed equivalent sensitivity and specificity, and can be tested on patients who are symptomatic for vaginitis/vaginosis. A "Detected" result should be coupled with clinical indicators for diagnosis. A "Not detected" result for this assay does not exclude bacterial or yeast involvement in a disease process. This assay has been approved by the U.S. Food and Drug Administration for testing vaginal specimens collected using the Cepheid Xpert Swab Collection Kit. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.
