Product Manual

18 60061-7 (2021-01) Accula SARS-CoV-2 IFU
Analytical Specificity - Interfering Substances
To assess substances with the potential to interfere with the performance of the Accula SARS-CoV-2 Test, contrived samples with SARS-
CoV-2 RNA (SARS-CoV-2 RNA/strain USA_WA1/2020) were tested in replicates of three (3) with each interfering substance 
 
-CoV-2 RNA was tested at 3X the LoD confirmed in the Limit of Detection Study described above. For
each positive sample, RNA was diluted into a pooled negative nasal and throat mix swab matrix to achieve a 3X LoD concentration.
The SARS-CoV-2 RNA was tested with an interferent concentration representing the highest concentration likely to be found in a
respiratory or throat sample. Potentially interfering substances that were sourced in their solid phase were re-suspended and diluted to a
concentration deemed to be likely worst case. Liquid phase potential interferents were not diluted before testing. Additionally, the SARS-
CoV-2 RNA was tested without the interfering substance as a control. Potential interferents and their concentrations, samples tested, and
test results are summarized in the table below. No interference was observed with any of the substances tested.
Accula SARS-CoV-2 Interfering Substances Evaluation
Potential
Interferent
Active Ingredient
Final
Concentration
Target
% Agreement with
Expected Results
Blood (Human)
NA
25%
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Chloroseptic Max
Phenol 1.5%, Glycerin 33%
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Cold&Flu Relief
Cough Syrup
Acetaminophen 21.7 mg/mL,
Dextromethorphan 0.67
mg/mL, Guaifenesin 13.3
mg/mL, Phenylephrine 0.33
mg/mL
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Listerine Cool Mint
Antiseptic Mouth
Wash
Eucalyptol 0.092%, Menthol
0.042%, Methyl Salicylate
0.060%, Thymol 0.064%
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Cepacol (throat
lozenge)
Benzocaine, Menthol
1 Lozenge/5 mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Sucrets
Dyclonine Hydrochloride,
Menthol
1 Lozenge/5 mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Crest Pro Health
Fluoride
Toothpaste
Stannous Fluoride 0.454%
(0.14% W/V Fluoride Ion)
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Eucalyptus Oil
4
Eucalyptus Oil
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Advil Liqui-Gels
Ibuprofen
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Miralax
Polyethylene Glycol
0.304 g/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Tums Extra
Strength
Calcium Carbonate
1 tum/2.5 mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Food Dye
N/A
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Whole Milk (Dairy)
1
N/A
1.60%
Positive SARS-COV-2(3X LoD)
100% (3/3)
12.50%
Negative
100% (2/2)
Orange Juice
N/A
50%
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Penicillin G
Penicillin G Sodium Salt
100 mg/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Cephalexin
Cephalexin
25 mg/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)