Product Manual

Sofia Lyme FIA Page 17 of 19
(RED), Serum Separator Tube (TIGER), Lithium Heparin, and Sodium Heparin. EDTA is not compatible with Sofia
Lyme FIA.
Interfering Substances
A study was performed to assess potential interfering substances with the Sofia Lyme FIA. The substances and
concentrations tested are described in Table 14, there was no interference or cross-reactivity results when
tested with the Sofia Lyme FIA.
Table 14
Sofia Lyme FIA Interfering Substances
Interfering Substance
Concentrations Tested
Bilirubin
15 mg/dL
Hemoglobin
20 g/dL
Lipids
750 mg/dL
Albumin
5.0 g/dL
Acetylsalicylic Acid
3.62 mmol/L
Amoxicillin
206 µmol/L
Azithromycin
15.3 µmol/L
Ceftriaxone
1460 µmol/L
Cefuroxime Axetil
1416 µmol/L
Doxycycline Hyclate
67.5 µmol/L
Erythromycin
81.6 µmol/L
Ibuprofen
2425 µmol/L
Minocycline
10.33 µmol/L
Penicillin G
33.67 µmol/L
Penicillin Phenoxymethyl
14.27 µmol/L
Prednisolone
8.31 µmol/L
Tetracyclines
34 µmol/L
Cross-Reactivity
The cross-reactivity of the Sofia Lyme FIA was evaluated with 17 disease state sample types that have the
potential to interfere with the Sofia Lyme FIA assay. Samples were characterized and obtained from commercial
vendors and did not include any first or second tier Lyme testing results. The total number of each disease state
sample type, as well as the number of positives observed with the Sofia Lyme FIA is summarized in Table 15.
Table 15
Sofia Lyme FIA Cross-Reactivity
Disease State Diagnosis
# of Samples
IgM Positive Results
IgG Positive Results
Anti-Nuclear Antibodies
10
4/10
1/10
Babesiosis
12
3/12
4/12
Chronic Fatigue Syndrome
12
2/12
2/12
Cytomegalovirus
11
2/11
1/11
Epstein Barr Virus
10
4/10
0/10
Fibromyalgia
10
1/10
0/10
H. pylori
10
4/10
0/10
HIV
11
2/11
0/11
Influenza
11
0/11
0/11
Leptospirosis
6
1/6
2/6
Lupus
20
8/20
4/20
Multiple Sclerosis
10
1/10
1/10
Parvovirus B19
15
4/15
1/15