Product Manual

6 60061-7 (2021-01) Accula SARS-CoV-2 IFU
SPECIMEN COLLECTION
Each test should be completed with a nasal swab sample using one SARS-CoV-2 Buffer vial.
Proper sample collection is an important step for an accurate test result. Carefully follow the instructions below.
NOTE: Use only the Collection Swabs supplied with the kit or one of the approved swab types listed below:
Nasal Swabs:
• Puritan Sterile Rayon Swab w/ Polystyrene Handle (REF. 25-806-1PR)
• Puritan Sterile Standard Foam Swab w/Polystyrene Handle (REF. 25-1506 1PF)
• 
o (REF. 502CS01) - Regular Size Nylon® Flocked Swab with 80mm Breakpoint
o (REF. 519CS01) - Regular Size Nylon® Flocked Swab with 100mm Breakpoint
o (REF. 520CS01) - Regular Size Nylon® Flocked Swab with 30mm Breakpoint
• McKesson Cotton Tip Wood Shaft 6 Inch Sterile (REF. 24-106-2S or REF. 24-106-1S)
• Dynarex Cotton Tipped Applicators (REF. 4305)
Nasal Mid-turbinate Swabs:
• 
o (REF. 56380CS01) - Contoured Adult Size Nylon® Flocked Swab with Stopper with 80mm Breakpoint
o (REF. 56780CS01) - Contoured Pediatric Size Nylon® Flocked Swab with Stopper with 80mm Breakpoint
o (REF. 56750CS01) - Contoured Pediatric Size Nylon® Flocked Swab with Stopper with 50mm Breakpoint
Nasal Swab Sample
To collect a nostril until you feel slight resistance. Firmly rotate the swab
against the nasal wall 10 times.
Using the same swab, repeat this sampling procedure in the other nostril.
Patient self-collection: On-site, supervised patient self-collection may be employed to reduce risk of SARS-CoV-2 transmission between
patients and testing site personnel. Patients may conduct nasal swab self-collection of themselves or a child, as described in the Self-
Collection Quick Reference Guide. Testing site personnel must provide a physical or digital copy of the Self-Collection Quick Reference
Guide to the patient prior to collection. Self-collection must occur on-site, under supervision by testing site personnel. Self-collection is
limited to patients 18 years and older. Collection by an adult on a child should only be performed on children 5 years and older. Nasal
swabs from children ages 0-4 years should be collected by the clinician.
NOTE: If the buffer solution contacts the skin, wash the area with soap and clean water and rinse thoroughly. Consult a physician if
irritation develops.
Nasal Mid-Turbinate Swab Sample
To collect a nasal mid-turbinate swab sample, first tilt the mid-turbinate swab,
insert swab into the nostril until resistance is met at turbinates. Rotate the swab several times against nasal wall.
Using the same swab, repeat this sampling procedure in the other nostril.
• Sample Elution Specimen swabs must be eluted in Accula buffer immediately after sample collection.
• Patient nasal swabs previously stored in media other than Accula SARS-CoV-2 Buffer are not recommended and may yield
invalid results or false results. For details, refer to the Limitations section.