Specimen Collection, Labelling, Storage, Preservation, Transportation, Processing and Referral for Woman’s Health Panel

The vaginal microflora is a dynamic ecosystem normally inhabited by lactobacilli. These bacteria support healthy vaginal conditions by maintaining an acidic environment that is inhospitable to other pathogenic microorganisms. The prevalence of lactobacilli in the vagina prevents its colonization by other pathogens. The most common alteration in vaginal microflora is a condition named Bacterial Vaginosis (BV). BV is a disorder characterized by an overgrowth of anaerobic bacteria in the vagina leading to a replacement of healthy lactobacilli. Bacterial species including Gardnerella vaginalis, Atopobium vaginae, Megaspaera Type 1 and Type 2, Bacterial Vaginosis-Associated Bacterium 2 (BVAB2), Mobiluncus species, Mycoplasma hominis, and Ureaplasma urealyticum are indicative diagnostic markers of BV.

General Guidelines:

The preferred specimen collection method for testing vaginal microflora is a vaginal swab collecting as much visible exudate as possible.

Collection from female patients: Vaginal Swab

  • Samples are collected using the Copan ESwab Liquid Amies Collection Kit.
  • Insert the flocked tip of the specimen swab approximately 2 inches into the vaginal opening.
  • Gently turn the swab and allow it to absorb the secretions. Collect as much visible exudate as possible.
  • Withdraw the swab carefully to avoid contamination.
  • Place swab(s) into the sterile vial containing 1.0 mL of Liquid Amies transporting medium.
  • Break the swab at the scored line on the shaft. Discard the shaft.
  • Recap the transport tube carefully to ensure the cap seals tightly.

Label the vial with the patient’s first and last name, date of birth, the date and time the sample was collected, and the specimen type. Additional comments may also be added.

General Specimen Handling:

If two samples are collected from the same patient, both swabs can be placed in the same vial. Aseptically, cut or break applicator sticks off near the tip to permit tightening of the cap.

Storage Conditions:

The specimen will be processed (nuclear extraction) for analysis within 72 hours after collection at the laboratory, keep it at room temperature (20-25ºC) or refrigerate at (2-8ºC). Otherwise, store refrigerated and ship on wet ice or refrigerant gel-packs. Avoid freezing specimens. Specimens that are frozen and then thawed release nucleases capable of cleaving the phosphodiester bonds of nucleic acids and may result in false negative test results. Refrigerated specimens will reach and maintain ambient temperature while preparing the sample for analysis. The Copan ESwab™ Liquid Amies collection devices used in this protocol stabilizes the bacterial count and parameters for up to 72 hours at room temperature. The specimens do not require refrigeration. The Copan ESwab™ Liquid Amies collection devices are suitable for extended processing and transport times, and for microbiological diagnosis, however, samples will be rejected if specimen exceeds the 72-hour limit specified by the in-house stability studies. Once the specimen has been processed, the extracted nucleic material may be stored frozen at approximately -20ºC in a non-frost-free freezer and shipped on dry ice if necessary.  If the analytical system fails, then processed patient samples are stored in -20°C non-frost-free freezer. Extracted samples can be stored at -15 to -20°C for up to 16 months.

Transportation of specimens:

Store and ship specimens at room temperature (5-25°C) within 24-72 hours of collection. For hand-carried transportation over a short distance, the specimen should be placed upright in appropriate racks.

For long distance transportation, it should be placed in three containers, i.e.:

  • A primary container which has the specimen and is leak-proof with a screw-cap.
  • A secondary container which is durable, waterproof and made of metal or plastic with a screw-cap.
  • A tertiary container is usually made of wood or card box. It should be capable of withstanding the shocks and trauma of transportation.

Federal shipping guidelines should be followed by the submitting practice.