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Louisiana Office of Public Health LaboratoriesTest NamePHL LocationCPT CodeSynonymsBrief Description of TestAmplified Nucleic Acid Test for Chlamydia trachomatis andNeisseria gonorrhoeaeOffice of Public Health Laboratory Baton Rouge87591, 87491CT/GC, Gonorrhea/Chlamydia, or Gen-Probe/ Hologic test, AptimaCombo 2The APTIMA Combo 2 Assay is a target amplification nucleic acidprobe test for the in vitro qualitative detection of Chlamydiatrachomatis and Neisseria gonorrhoeae using the TIGRIS DTSAutomated Analyzer and/or PANTHER SYSTEMAptima CT Results ReportedCT PosPositive for CT rRNACT NegPresumed negative for CT rRNACT EquivIndeterminate, a new specimen should becollectedCT InvalidIndeterminate, a new specimen should becollectedPossible ResultsAptima GC ResultsGC PosGC NegGC EquivGC InvalidReference RangeSpecimen TypeSpecimen Container(s):Minimum volumeaccepted:Collection InstructionsReportedPositive for GC rRNAPresumed negative for GC rRNAIndeterminate, a new specimen should becollectedIndeterminate, a new specimen should becollectedPresumed negativeUrine, female vaginal swab (Multitest Swab only), femaleendocervical swab (Unisex Swab only), male urethral swab (UnisexSwab only), Pharyngeal (throat) swab, Rectal swabAptima Unisex Swab Specimen Collection Kit (white tube andswabs with blue shaft and white shaft)Aptima Multitest Swab Specimen Collection Kit (orange tube withpink shaft)Aptima Urine Specimen Collection Kit (yellow tube)** Fax or email Lab Supply Request Form to obtain kits **Liquid levels in urine specimen must fall between the two blackindicator lines on the urine transport tube label.If the test was ordered in StarLIMS, label the tube with the barcodegenerated. If ordering with manual forms or you do not have theability to print StarLIMS barcodes, label specimen with Patient

Name and a 2nd Unique Identifier such as a chart number ormedical record number. DOB is not considered unique. Ifspecimen is a swab, include source.Complete a STD/HIV Lab Form for each specimen. Labsubmission form must be thoroughly completed with patient’s firstand last name, 2nd unique identifier that matches with the labeledsample, gender, date of birth, date and time of collection, specimensource, test requested, submitter’s name, address, fax and contactnumber. Additional information regarding patients’ address isrequested.Patient Age RequirementAll Swab Specimens: Patients 14 years of age and aboveUrine Specimens: Patients 4 years of age and aboveTransport specimen to laboratory as soon as possible aftercollection. Keep submission forms insulated from specimens.Female Vaginal Swab Specimens (Multitest Swab kit orangetube only) Hold the swab (pink shaft swab) at the score line to avoidbreaking. Carefully insert into vagina about 2 inches (5cm) inside the opening of the vagina. Gently rotate the swab for 10 to 30 seconds to ensureadequate sampling. Make sure the swab touches the wallsof the vagina. Withdraw the swab carefully; avoid any contact with theskin. Immediately place the specimen collection swab into thetransport tube. Carefully break the swab shaft against theside of the tube at the score line and discard the top portionof the swab shaft; use care to avoid splashing contents. Capthe tube tightly.Female Endocervical Swab Specimens (Unisex Swab kit whitetube only) Remove excess mucus from the "cervical os andsurrounding mucosa using the cleaning swab (white shaftswab in the package with the red printing). DISCARDTHIS WHITE SWAB. Insert the specimen collection swab (blue shaft swab in thepackage with the green printing) into the endocervicalcanal. Gently rotate the swab clockwise for 10 to 30 seconds inthe endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid any contact with thevaginal mucosa.

Immediately place the specimen collection swab into thetransport tube. Carefully break the swab shaft against theside of the tube at the score line and discard the top portionof the swab shaft; use care to avoid splashing contents. Capthe tube tightly.Male Urethral Swab Specimens (Unisex Swab kit white tubeonly) The patient should not have urinated for at least 1 hourprior to sample collection. Insert the specimen collection swab (blue shaft swab in thepackage with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for 2 to 3 seconds in theurethra to ensure adequate sampling. Withdraw the swab carefully. Immediately place the specimen collection swab into thetransport tube. Carefully break the swab against the side ofthe tube at the score line and discard the top portion of theswab shaft; use care to avoid splashing contents. Cap thetube tightly.Male and Female Urine Specimens The patient should not have urinated for at least 1 hourprior to specimen collection. Direct patient to provide a first-catch urine into a urinecollection cup free of any preservatives Female patients should not cleanse the labial area prior toproviding the specimen. Transfer 2mL of urine into the urine specimen transporttube using the disposable pipette provided. The correctvolume of urine has been added when the fluid level isbetween the black fill lines on the urine specimen transporttube. Cap the tube tightly.Male and Female Rectal SwabsFor the Unisex swab: Gather collection materials and use the small APTIMAtesting swab (blue shaft swab), not the larger cleansingswab. Insert the swab approximately 3 – 5 cm into the rectum androtate against the rectal wall several times (at least 3 times). Swabs that are grossly contaminated with feces should bediscarded and the collection repeated. Carefully remove the swab, and insert the swab into theAPTIMA transport tube. Break off the swab at the score line and discard the topportion of the swab shaft; use care to avoid splashingcontents. Cap the tube tightly.

For the Multitest swab (Orange): Hold the swab (pink shaft swab) at the score line to avoidbreaking. Carefully insert into rectum about 1-2 inches (35 cm) past the anal margin (the outside of the anus). Gently rotate the swab for 5 to 10 seconds to ensureadequate sampling. Withdraw the swab carefully; avoidany contact with the skin. Immediately place the specimen collection swab into thetransport tube. Carefully break the swab shaft against theside of the tube at the score line and discard the top portionof the swab shaft; use care to avoid splashing contents. Capthe tube tightly.Male and Female Throat Swab CollectionFor the Unisex swab: Gather collection materials and use the small APTIMAtesting swab (blue shaft swab), not the larger cleansingswab. Using a tongue depressor, insert the swab and vigorouslyrub the tonsils and the posterior pharynx. Carefully remove the swab, not touching any area of themouth. Insert the swab into the APTIMA transport tube and breakoff the swab at the score line. Cap the tube tightly.For the Multitest swab (Orange): Hold the swab (pink shaft swab) at the score line to avoidbreaking. Carefully insert the swab into mouth ensuringcontact with bilateral tonsils and the back of the throat. Withdraw the swab carefully; avoid any contact with theinside of cheeks and tongue. Immediately place the specimen collection swab into thetransport tube. Carefully break the swab shaft against theside of the tube at the score line and discard the top portionof the swab shaft; use care to avoid splashing contents. Capthe tube tightly.Storage and TransportInstructionsThe samples must be stored at 2 C to 30 C until tested. Thissample range must be maintained during transport of the samples tothe laboratory. Swab specimens must be assayed with the APTIMAAssays within 60 days of collection and urine specimens within 30days of collection. If longer storage is needed, store at -20 C to-70 C for up to 116 days for urine and up to 12 months for swabs.Prevent cross-contamination by packaging in the multicompartment bubble wrap pouches or put each specimen

into a separate leak-proof specimen bag before placing incoolers for shipment. Causes for Rejection Limitations of theProcedureInterfering SubstancesReferencesAdditional InformationTwo swabs in specimen tubeWhite swab in specimen tubeSwab with wooden shaft in specimen tubeInsufficient urine specimen volume received (liquid levelsfor urine specimens must be between the two blackindicator lines on the urine transport tube label)Overfilled urine specimen tubeSpecimen collected from the eye2-30 C Urine specimen received in the laboratory morethan 30 days after collection date; 2-30 C swab samplereceived in the laboratory more than 60 days after thecollection date.No swab in specimen tubeInadequate sample, patient, or submitter informationSpecimen collected in expired transport media. Expirationdates listed on the collection kits pertain to the collectionsite and not the testing facility. Samples collected any timeprior to the expiration date of the collection kit, andtransported and stored in accordance with the packageinsert, are valid for testing even if the expiration date on thecollection tube has passed.Specimens tubes not separated during transport.Urine specimens on patients aged 3 and under.Swab specimen on patient aged 13 and under.A negative test result does not exclude the possibility of infectionbecause tests results may be affected by improper specimencollection, handling, transport, technical error, specimen mix-up orconcurrent antibiotic therapy. Additionally, the concentration oforganisms may be below the sensitivity of the test. Results from theGen-Probe/Hologic Aptima System should be used in conjunctionwith other clinical data available to the clinician. If the clinicalindication strongly suggests infection, additional specimens shouldbe collected for further testing. Identification methods can yieldfalse positive results. In those instances additional testing isrecommended.Excessive temperatures, Patient on antibiotic therapy, Inappropriatecollection techniques, see package inserts from Gen-Probe/ HologicAPTIMA Combo 2 Collection Kits. Center for Disease Control, National Center or HIV, STD, TBPrevention, Division of Sexually Transmitted Disease Aptima Combo 2 Assay Package InsertNone

Release Date01/16/2020Warning: If you have printed a copy of this information please be advised that the LouisianaOffice of Public Health Laboratories website and methods are updated on a regular basis. Pleasecheck the on-line version of this document to ensure you are relying on the most recent release.LO.FM.GEN.043 V24 2013

The APTIMA Combo 2 Assay is a target amplification nucleic acid . Carefully insert into vagina about 2 inches (5 cm) inside the opening of the vagina. Gently rotate the swab for 10 to 30 seconds to ensure . package with the green printing) 2 to 4 cm into the urethra.