PointofCare.net Vendor Page

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.

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.