DEVICE USE INSTRUCTIONS

 

Dip Stick

The dipstick device is the primary testing component of each thin-layer chromatography-based medical device. The dipstick device may come with specific accessory materials such as disposable dropper reagent bottles, disposable reaction cups and/or a disposable cotton swab, depending on the rapid test. For best results, carefully follow test-specific instructions for the preparation of samples, then submerge the dipstick in sample up to the line indicated by the arrows (see picture) for ten seconds. Place the dipstick on a flat surface. Read results at or within five minutes but no later than ten minutes, or at or within ten minutes but no later than fifteen minutes, depending on the test.

Cassette

The cassette device comes with test-specific accessory materials such as a disposable dropper, disposable dropper reagent bottles, disposable reaction tubes and/or a disposable cotton swab. For best results, lay the device on a flat surface and carefully follow specific instructions for the use of accessory materials to collect, process and test samples. Unlike devices designed for dipping, the cassette device is designed with a sample well in which to drop the prepared sample and/or test reagent. Read results at or within five minutes but no later than ten minutes, or at or within ten minutes but no later than fifteen minutes, depending on the test.

Dip Card

The dip card device is designed to test multiple dipstick strips at one time and is limited to the Drugs of Abuse product line. For best results, remove the cap and submerge the device in sample up to the line designated by the arrows (see picture). After ten seconds, re-cap the device and place it on a flat surface. Read results at or within five minutes but no later than ten minutes.

Midstream

The midstream device is designed with a long wick to absorb urine sample from the urine stream. This allows the user to skip the urine sample collection process and facilitates device use. For best results, remove the colored cap just before use and hold the device in the urine stream for six seconds. Then, re-cap the device and place it on a flat surface. Read test results at no later than ten minutes. The midstream device is used solely for the Fertility, Ovulation and Pregnancy product line.



PRODUCT CATEGORIES

Infectious Disease

The Infectious Disease rapid tests include diagnostic kits for the detection of Strep A, H. pylori, and Chlamydia. These products include the use of accessory devices and sample preparation reagents and/or running buffer depending on the product. H. pylori rapid tests function with both blood serum and whole blood. The products are designed to provide determinations within ten minutes.

Pregnancy and Fertility

The Fertility, Ovulation and Pregnancy rapid tests are designed to provide rapid preliminary diagnoses in the area of women's reproductive health. These products come in three device formats, including the midstream device. The HCG product line includes the HCG Combo test which allows for detection of HCG in both urine and blood serum. The products are designed to provide determinations within five minutes.

Tumor Markers

The Tumor Marker rapid test products include diagnostic kits for the detection of Fecal Occult Bleeding (FOB) and PSA (Prostate Specific Antigen). PSA tests include a Semi-Quantitative test that provides a third band as an in-test quantitative reference. PSA products exist for both blood serum and whole blood. The FOB test uses prepared fecal samples but can also detect blood in urine. Tumor Marker diagnostic kits come with accessories and running buffers. Tests are designed to be read within ten minutes.

Drugs of Abuse

The Drugs of Abuse rapid test products come in three categories: Single Drug, Multi-Drug and Multi-In-One Drug tests. Drugs tested for include methadone, amphetamine, methamphetamine, cocaine, marijuana (THC), barbiturates, morphine (opiates), benzodiazepines, phencyclidine (PCP), tricyclic antidepressant (TCA) and MDMA (ecstasy). While most Drugs of Abuse rapid tests are designed to be read within five minutes, PCP and benzodiazepines rapid tests are best read between five and eight minutes.