Special Instructions

Results from the APTIMA® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. 

The APTIMA® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. 

For a complete list of assay limitations we recommend that you review the manufacturers package insert, www.hologic.com//package-inserts/clinical-diagnostics-blood-screening/assays-and-tests/aptima-combo-2-assay-ctng. 

Collect cervical specimens in ThinPrep® Pap Test vials containing PreservCyt® Solution with broom-type or cytobrush/spatula collection devices according to the manufacturers instructions. 

If the ThinPrep® Aliquot Removal procedure will be used prior to cytology processing, refer to the ThinPrep® 2000 or ThinPrep® 3000 System instructions for use on aliquot removal. Transfer 1 mL of the removed aliquot into an APTIMA® Specimen Transfer tube according to the instructions in the APTIMA® Specimen Transfer Kit package insert. 

If testing the specimen after cytology processing using the ThinPrep® 2000 System, process the ThinPrep® liquid cytology specimen in accordance with the ThinPrep® 2000 System instructions for use and the APTIMA® Specimen Transfer Kit package insert. Transfer 1 mL of the fluid remaining in the ThinPrep® Pap test vial into an APTIMA® Specimen Transfer tube according to the instructions in the APTIMA® Specimen Transfer Kit package insert. 
Specimens should be transferred to an APTIMA® Specimen Transfer tube within 30 days of collection if stored at room temperature (see section 3.2). 

ThinPrep PreservCyt® Solution Vials: 1 mL of PreservCyt® Solution specimen must be transferred into 2.9 mL of APTIMA® specimen transport media. Transfer into APTIMA® transport media tubes contained in Specimen Transfer kits, Vaginal Swab collection kits, or Unisex Swab collection kits.