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  • 品牌:NOVABIOS
  • 产地:美国
  • 货号:NB3320
  • 发布日期: 2017-05-27
  • 更新日期: 2025-06-04
产品详请
产地 美国
品牌 NOVABIOS
货号 NB3320
保存条件 1-30度
英文名称 Drug test
保质期 18个月个月

  One Step Drug Screen Test Card 


Package Insert for Single and Multi Drug Screen Test Cards

This Instruction Sheet is for testing of any combination of Cocaine and Marijuana.

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

For healthcare professionals including professionals at point of care sites.

For in vitro diagnostic use only.

INTENDED USE

The One Step Drug Screen Test Card is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations:

Test

Calibrator

Cut-off

Cocaine (COC)

Benzoylecgonine

300 ng/mL

Marijuana (THC)

11-nor-Δ9-THC-9 COOH

50 ng/Ml


DIRECTIONS FOR USE

Allow the test card, urine specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.    Bring the pouch to room temperature before opening it. Remove the test card from the sealed pouch and use it as soon as possible. Remove the cap from the end of the test card. With arrows pointing toward the urine specimen, immerse the strip(s) of the test card vertically in the urine specimen for at least 10-15 seconds. Immerse the test card to at least the level of the wavy lines on the strip(s), but not above the arrow(s) on the test card. See the illustration below.

2.    Place the test card on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not interpret results after 10 minutes.


%Agreement with Commercial Kit


COC

THC

PositiveAgreement

95%

98%

NegativeAgreement

>99%

100%

TotalResults

98%

99%

 


A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below.

Drug   concentration


THC

COC

Cut-off Range

n

-

+

-

+

0%   Cut-off

30

30

0

30

0

-50%   Cut-off

30

30

0

30

0

-25%   Cut-off

30

12

18

30

0

Cut-off

30

1

29

4

26

+25%   Cut-off

30

1

29

0

30

+50% Cut-off

30

0

30

0

30

Analytical Specificity

The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by One Step Drug Screen Test Card at 5 minutes.

COCAINE

Ng/ml

Benzoylecgonine

300

Cocaine HCl

780

Cocaethylene

12,500

Ecgonine HCl

32,000

MARIJUANA   (THC)


11-nor-D-THC-9 COOH

50

Cannabinol

20,000

11-nor-D8-THC-9 COOH

30

D-THC

15,000

D-THC

15,000

Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cut-off levels respectively. The One Step Drug Screen Test Card was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug positive urine containing Cocaine, Barbiturates, Benzodiazepine, Amphetamine, Methamphetamine, Marijuana, Methadone, Opiate, Phencyclidine or Tricyclic Antidepressant. The following compounds show no cross-reactivity when tested with One Step Drug Screen Test Card at a concentration of 100 mg/mL.

1. Ambre J.  J. Anal. Toxicol. 1985; 9:241.

2.  Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.


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