FREQUENTLY ASKED QUESTIONS

The following questions and answers are pertinent to our products and may be of use to you.

For information on how to use our product and more specific product information, please visit the Products & Services section of our web-site.  Package Inserts are available on our Customer Only section for more detailed product information.  Additionally, we have provided links from our web-site to locations designed specifically to answer your Drugs of Abuse or Health questions, including links to the NIDA and SAMHSA.  Please take a moment to review the Related Links. 

For additional information, or for questions not answered below, please Contact Us with your specific questions or requests and we will respond within 24 hours.


What is the sensitivity of Pan Probe Biotech diagnostic products?
Pan Probe Biotech designs products to detect compounds at specific cut-off levels. A cut-off level is the minimum concentration at which a test should produce a positive result. For drugs of abuse, detection cut-off levels have been established by the Substance Abuse and Mental Health Services Administration (SAMHSA). These are also the cut-off detection levels required for 510k approval by the US Food and Drug Administration (FDA) and product sale within the United States. Please see our Custom Design product section for information on our ability to design product according to your cut-off sensitivity specifications.
Are Pan Probe Biotech,Inc.’s rapid test results conclusive?
While LiveSureTM products have a very high percentage of accuracy, these screening tests serve primarily as preliminary diagnostic tools to help catch the early onset of disease or the presence of drugs of abuse in urine. Further confirmation of results is necessary using quantitative methods. SAMHSA has determined GC/MS as the preferred confirmatory method.

If a preliminary negative test result returns positive under confirmatory testing, it may be because the test was designed to detect compounds at slightly above the detection cut-off level. On the other hand, if a preliminary positive result returns negative under confirmatory testing, it may be because the test was designed to detect compounds at slightly below the detection cut-off level.
What is the specificity of the LiveSureTM products?
“Specificity” is the ability of a test to specifically detect the target compounds while not responding to compounds with similar structure. Our Drugs of Abuse products were all tested against structurally related and non-related compounds to verify product specificity before being released to the market.

Our Fertility, Ovulation and Pregnancy products test for glycoprotein hormones that are structurally related. This creates the opportunity for product to detect hormones for which it is not intended (known as “cross-reactivity”). Such being the case, each rapid test lot in this product category is tested for cross-reactivity with other Fertility, Ovulation and Pregnancy hormones and for human thyroid stimulating hormone (TSH), also known to cause cross-reactivity. For example, HCG is tested against LH, LH is tested against HCG, FSH and TSH, and FSH is tested against HCG, LH and TSH. Our Fertility, Ovulation and Pregnancy rapid tests are designed specifically to detect the hormone for which they are intended.

For more information on testing for cross-reactivity of Drugs of Abuse products, please see the package inserts available in the Customer Only section of this web-site.
How should Pan Probe Biotech product results be read?
Each Pan Probe Biotech product, with the exception of the PSA Semi-Quantitative Rapid Test, is designed to produce one or two colored bands depending on the test type. For example, Drugs of Abuse rapid tests will produce two bands for a negative result and one band for a positive result. All other products, such as HCG, LH, FSH, Chlamydia, etc., will produce one band for a negative result and two bands for a positive result. This is due to the type of assay incorporated into the product. To differentiate between the bands, one band should always appear in the Control Region. If there is a second band, it will appear in the Test Region. The Test Region is where test results should be read. Time frames for reading test results are test specific but fall at or within 5 minutes, or at or within 10 minutes, depending on the product. Tests results are considered invalid in two scenarios: 1) if no band appears in both the Control Region and the Test Region, or 2) if a band appears in the Test Region but no band appears in the Control Region.
What accounts for variation in the intensity of colored bands in test results?
There are a number of factors determining line intensity. One is the concentration of the target compound in the sample. Tests results are designed to increase in intensity in correlation with compound concentration, with the exception of HCG (described below).

Certain drugs of abuse have unique characteristics. THC, for example, is known to produce results of lighter intensity than other drugs of abuse at correlating sample concentrations. Morphine (Opiates) is known to produce results of very strong intensity compared to other drugs of abuse at correlating concentrations. It is important for Drugs of Abuse product to note that the presence of any line in the test region, no matter what the intensity, is considered a negative result.

HCG is unique in that, at very high concentrations, it will initially show results of strong intensity and then begin to fade. This is known as a “hook effect.”

One other factor that influences variation in line intensity is test design. Our production lab works very hard to achieve consistency between lots of the same product so that line intensity varies little between lots of similar product and between random samples from the same lot.

Certain external factors also influence the line intensity in test results. For example, the pH of urine samples needs to fall within the appropriate range for test results to be accurate. If the pH is either too high or too low, protein components of the tests could denature, or a test could be otherwise adversely affected. The age of the sample (e.g., old sample vs. new sample) also affects line intensity. If it appears sample has been tampered with, if sample pH falls outside of normal ranges for urine, or if old sample appears unsuitable for use (turbidity, for example), it is best to collect a new sample to obtain accurate test results.

Variations in line intensity may also occur due to errors in product use. It is important to follow test instructions carefully.

If results are in question, please retest the sample using a new test device.

Each product is designed to be effective for eighteen months of shelf life at proper storage. However, newer product will have results of stronger intensity than older product. Protein-based products degrade over time.
What are optimal storage conditions for Pan Probe Biotech product?
Each product is sealed in a foil pouch with the expiration date printed on the outside of the pouch. Each pouch also contains desiccate to help regulate internal pouch humidity. Product can be stored at 2-25°C for eighteen months. Storage at temperatures higher than 25°C will accelerate degradation of the product. Do not use product beyond the expiration date printed on the pouch. Furthermore, it is important not to open the foil pouch until ready to begin testing and to avoid delay in use of product once opened. Exposing product to the environment for long periods of time before use can degrade product and affect the results.
What proof is there that Pan Probe Biotech products can be trusted?
Pan Probe Biotech, Inc. is the owner of more than ten 510k approvals from the US FDA for product sold in the United States. In addition, Pan Probe Biotech has been granted permission to export products in all categories in the form of Certificates to Foreign Governments and Certificates of Exportability. All product was placed under rigorous in-house testing before being submitted to clinical trials (for 510k approval) or before being added to our product list.
What other measures are in place to build customer trust in our products?
Pan Probe Biotech’s Quality Control Department tests every lot of product or product component at various stages of the production process before it is released for shipment. The QC Department provides a Certificate of Analysis with shipments to reflect Final QC results before product release and to verify product quality.