Product Manual

60061-7 (2021-01) Accula SARS-CoV-2 IFU 19
Potential
Interferent
Active Ingredient
Final
Concentration
Target
% Agreement with
Expected Results
Mucin, Type II
(from porcine
stomach)
2
Purified mucin protein
50 mg/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
100 mg/mL
Negative
100% (2/2)
Tobramycin
(antibacterial)
3
Tobramycin
75 mg/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Amoxicillin
3
Amoxicillin
100 mg/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Anti-viral drug
Zanamivir
10 mg/mL
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Nasal spray
Phenylephrine
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Nasal spray
Oxymetazioline
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Nasal spray
Sodium Chloride
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Nasal
Corticosteroid
Triamcinolone
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
Zicam (Nasal Gel,
homeopathic
allergy relief)
Oxymetazoline hydrochloride
0.05%
Neat
Positive SARS-COV-2(3X LoD)
100% (3/3)
Negative
100% (2/2)
1  Milk inhibited target RNA at 12.5%. Milk was diluted to 6.25%, and still inhibited 3 of 3 reactions, and was subsequently diluted to
1.6%, which showed 100% positive target lines. Internal positive control was active and visible at 12.5% milk.
2  Mucin inhibited target RNA at 100 mg/mL. Mucin was diluted to 50 mg/mL and showed 3 positives out of 3 attempts (100%).
Internal positive control was active and visible at 100 mg/mL of Mucin.
3  Tobramycin and Amoxicillin positive samples were initially tested without RNA by mistake. These were repeated and yielded 100%
expected results.
4  Eucalyptus Oil was used as a substitute for Halls Triple Soothing Cough Drops.
FDA SARS-CoV-2 Reference Panel Testing
The evaluation of sensitivity and MERS-CoV cross-reactivity was performed using reference material (T1), blinded samples and a
standard protocol provided by the FDA. The study included a range finding study and a confirmatory study for LoD. Blinded sample
testing was used to establish specificity and to corroborate the LoD. Testing was performed using the Accula SARS-CoV-2 Test with the
Accula Dock. The results are summarized in the table below.
Summary of LoD Confirmation Result using the FDA SARS-CoV-2 Reference Panel
Reference Materials Provided by FDA
Specimen Type
Product LoD
Cross-
Reactivity
SARS-CoV-2
Nasal swab
4.75 x 10
2
NDU/mL
N/A
MERS-CoV
N/A
ND
NDU/mL = RNA NAAT detectable units/mL
N/A: Not applicable
ND: Not detected
Clinical Evaluation
Testing of Contrived Samples
Thirty (30) negative samples and 30 positive contrived samples were tested with the Accula SARS-CoV-2 Test. Negative samples were
collected from consented healthy volunteers under IRB approval. A throat swab and a nasal swab was collected from a donor and eluted