Performance Characteristics - Alere TestPack+Plus hCG Urine Manual Del Usuario

9. False positive and false negative pregnancy tests may be observed in
patients with abnormal bladder or kidney function e.g. enterocystoplasties
and renal failure.
10. Inconsistent results may be obtained if the urine specimen contains an
excessive amount of bacteria.
11. If the test result is not consistent with clinical evidence, further evaluation
may be required.
EXPECTED RESULTS
Urine specimens from pre-menopausal females generally contain <5mlU/ml
hCG; levels are generally <10mlU/ml in healthy males and post-menopausal
females 2 . On the first day of the first missed period, the levels of maternal
hCG are normally 50-250mlU/ml 3 .

PERFORMANCE CHARACTERISTICS

Sensitivity
Alere TM TestPack hCG Urine can detect hCG in urine at concentrations of
25mlU/ml or greater. This sensitivity has been determined against the 4
International hCG Standard (WHO) . Specimens containing less than 5mlU/ml
1
should give negative results.
Prozone effect
Alere TestPack hCG Urine has been shown to produce positive results
TM
with specimens containing up to and including 1,000,000mlU/ml hCG, which is
higher than the maximum level expected during typical pregnancy.
Specificity
Alere TestPack hCG Urine has been evaluated for its cross-reactivity with
TM
a variety of substances, including other hormones found in urine. No cross-
reactivity was detected when the following substances were added
to both "positive" (containing 25mlU/ml hCG) and "negative" urine specimens:
LH (1000mlU/ml), FSH (1000mlU/ml), TSH (1000µlU/ml).
EN
INTERFERING SUBSTANCES
The following potentially interfering substances were added to hCG negative
and hCG positive (containing 25 mlU/ml hCG) specimens. None of the
substances interfered with the assay at the concentrations tested.
Acetaminophen
Acetoacetic Acid
Acetone
Albumin (human serum)
Acetosalicyclic Acid
Ampicillin
Ascorbic Acid
Atrophine
Biotin
Bilirubin
Caffeine
Creatinine
Dextromethorphan
th
Diphenhydramine
EDTA
Ephedrine
Ethanol
Estrone ß-D Glucuronide
Gentisic Acid
Glucose
Haemoglobin
Hydroxybutyric Acid
Human Serum Proteins
Ibuprofen
Nicotine
(20 mg/dL)
(2000 mg/dL)
(1000 mg/dL)
(1200 mg/dL)
(20 mg/dL)
(20 mg/dL)
(200 mg/dL)
(20 mg/dL)
(25 µg/dL)
(1 mg/dL)
(20 mg/dL)
(200 mg/dL)
(20 mg/dL)
(20 mg/dL)
(40 mg/dL)
(20 mg/dL)
(1%)
(100 µg/dL)
(20 mg/dL)
(10000 mg/dL)
(360 mg/dL)
(100 mg/dL)
(2000 mg/dL)
(40 mg/dL)
(20 µg/dL)
4
Oxalic Acid (60 mg/dL)
Oxytetracycline (30 mg/dL)
Phenylpropanolamine (4000 mg/dL)
5ß-Pregnane-3α, 20α-diol Glucuronide (100 µg/dL)
Ribovflavin (2 mg/dL)
Salicylic Acid (20 mg/dL)
Sodium Carbonate (800 mg/dL)
Sodium Chloride (6800 mg/dL)
Tetracycline (30 mg/dL)
Urea (2000 mg/dL)
Uric Acid (100 mg/dL)
In addition no pH effect in range pH 4.5 to pH 8.5.