Product Manual

18
TABLE 14
O
raQuick ADVANCE
®
R
apid HIV-1/2 Antibody Test Reactivity with Specimens from Individuals with Potentially
I
nterfering Medical Conditions and Specimens with Interfering Substances
OraQuick ADVANCE
®
Results
M
edical Condition (n = 321) Reactive Non-Reactive
M
ultiparous women 1
2
1
4
Anti-nuclear antibody (ANA) 0 17
Lupus 0 15
Rheumatoid factor 1
2
17
Cytomegalovirus (CMV) 0 15
E
pstein Barr virus (EBV) 1
2
1
4
H
epatitis A virus (HAV) 3
1
1
7
H
epatitis B virus (HBV) 1
2
1
6
Hepatitis C virus (HCV) 0 15
Human T-cell Lymphotropic virus Type I (HTLV-I) 0 15
Human T-cell Lymphotropic virus Type II (HTLV-II) 0 15
Rubella 0 15
IgG gammopathies 0 13
IgM gammopathies 0 12
Syphilis 0 15
Toxoplasmosis 0 15
Tuberculosis 0 15
Influenza 0 10
Multiple transfusions 0 10
Hemophiliac 0 10
Herpes Simplex virus 05
Cirrhosis 05
Dialysis patient 04
Colon cancer 04
HTLV I/II 02
Chlamydia 03
Anti-scl or anti-rnp antibody 03
Breast cancer 01
Anti-DNA antibody 01
Gonorrhea 01
Interfering Substances (n = 211)
Elevated Bilirubin 0 20
Elevated Hemoglobin 0 20
Elevated Triglycerides 0 20
Elevated Protein 0 20
Bacterially Contaminated 0 25
Visual Hemolysis (hemolytic) 05
Icteric 05
Lipemic 04
Sodium Heparin
3
0 24
EDTA
3
0 24
Sodium Citrate
3
0 24
1
A total of 3 of the 20 HAV specimens were OraQuick ADVANCE
®
falsely reactive. Two of the 3 specimens
were OraQuick ADVANCE
®
non-reactive at the 20-25 minute read time and reactive at the 55-60 minute
read time. The remaining specimen was reactive at both read times.
2
One of the specimens was OraQuick ADVANCE
®
non-reactive at the 20-25 minute read time and reactive
at the 55-60 minute read time.
3
The OraQuick ADVANCE
®
assay maximum read time for these specimens was 40 minutes. Based upon
specimen storage for 5 days at 2-30˚C.
3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 20