Alfa
Scientific Designs, Inc.
12330 Stowe Drive
Poway, CA 92064
Tel: (858)
513-3888
Toll Free: (877) 204-5071
info@alfascientific.com I
www.alfascientific.com
CORPORATE
DESCRIPTION:
Alfa
Scientific Designs is an FDA registered IVD manufacturer with ISO/EN
certifications engaged in the development and manufacturing of rapid in-vitro
diagnostic testing products. We have developed a broad line of products under
the Instant-View brand (Instant-View®
Drug Screen Tests, Instant-View®
Fertility Tests,
Instant-View®
Fecal Occult Blood Test, for
the point-of-care marketplace to aid in the detection of drugs of abuse,
fertility and cancer markers.
We are committed to consistently providing our
customers with high quality products, professional service and competitive
prices.
All
products are evaluated from design inception to meet the regulatory requirements
of domestic and international healthcare authorities. We have over 30 products
with FDA 510(k) clearance and 40 products with CE Mark certification
demonstrating our dedication to providing easy-to-use, cost effective products
for the biomedical and healthcare markets in the U.S. and abroad.
Products
Instant-View®
Drug Screen Tests
CLIA
Classification (Waived, Moderately complex):
Moderately complex
Analytes
performed on this device
|
Amphetamines:
1000 ng/ml
|
Marijuana
(THC): 50 ng/mL |
Morphine: 300, 2000 ng/ml |
|
Barbiturates:
200 ng/ml
|
Methamphetamine:
500 ng/ml, 1000 ng/ml |
Phencyclidine: 25 ng/ml |
|
Benzodiazepine:
300 ng/ml
|
Methadone:
300 ng/ml |
Propoxyphene: 300 ng/ml |
|
Cocaine:
300 ng/ml
|
MDMA
(Ecstasy): 500 ng/ml |
Tricyclids (TCA): 1000 ng/ml |
CPT
Code:
- Drug
screen, multiple classes: 80100
- Drug
Screen, single class: 80101
Test
methodology: Lateral
Flow Immunoassay
Sample
volume: About 160ml
of urine
Time to
result:
4-7 minutes
Units
in which the test is reported:
Positive or Negative (qualitative)
Other:
The
Instant-View Drug Screens are available in cassette, dip strip and
multi-panel formats. Each format includes a built-in control. The
multi-panel can test from 2 to 12 analytes at one time and can use
a dip and read procedure or the transfer pipette method. The tests
are FDA 510(k)-cleared and manufactured in the U.S.
Instant-View®
Fertility Tests
CLIA
Classification (Waived, Moderately complex):
Waived
Analytes
performed on this device:
Human Chorionic Gonadotropin (hCG) and human Luteinizing Hormone (LH)
CPT
Code:
-
Pregnancy,
urine: 81025
- Ovulation
(LH): 84830
- Pregnancy, serum: 84703
Test
methodology: Lateral
Flow Immunoassay
Sample
volume: About 160ml
of urine
Time to
result: 2-3
minutes
Units
in which the test is reported: Positive
or Negative (qualitative)
Other:
The
Instant-View Fertility tests are FDA 510(k)-cleared and
manufactured in the U.S.
Instant-View®
Fecal Occult Blood Test
CLIA Classification (Waived,
Moderately complex):
Waived
Analytes performed on this
device:
human hemoglobin
CPT Code:
82274
Test methodology:
Lateral Flow Immunoassay
Sample volume:
About
160ml
of specimen sample in extraction buffer
Time to result:
5-10 minutes
Units in which the test is
reported: Positive or
Negative (qualitative)
Advantages:
-
Cut-off
level = 50 μg hHb/g feces
-
Economical,
convenient, odor-free collection tube maintains the integrity
of the specimen sample
-
Specifically
designed collection tube allows short and long-term specimen
storage: 12-14 days at 15-30°C,
2 months at 4°C
or 2 years at -20°C
-
Specimen
collection tube doubles as applicator for use with the test
cassette
-
No
dietary restrictions
-
510(k)-cleared
and manufactured in the U.S.
ysfunction due to aspirin
(ASA) ingestion in citrated whole blood for the point of care or laboratory
setting.
