Available again: PRE-PEN is the only FDA approved skin test for penicillin allergy

From pre-pen.com:

In 2009, ALK-Abelló and AllerQuest, LLC announced the return of PRE-PEN® to the market. PRE-PEN is penicilloyl-polylysine (PPL).

ALK is the exclusive distributor of PRE-PEN® which received FDA approval on September 18, 2009. Manufacturing began in October 2009 at AllerQuest's dedicated penicillin production facility in Plainville, CT.

PRE-PEN® is the only commercially available FDA approved skin test for the detection of penicillin allergy.

PRE-PEN® is a clear, colorless, sterile solution supplied in 0.25mL sealed glass ampules. Each ampule is sufficient to evaluate one patient by skin prick test and intradermal test, in duplicate.

PRE-PEN® is sold in boxes of 5 ampules intended for single patient use only.

Over 30 million Americans are suspected to be allergic to penicillin, but most of these people may be able to be treated safely with penicillin and related antibiotics. In past years, in the absence of a penicillin test, allergy specialists were unable to test patients for penicillin sensitivity. ALK and AllerQuest are bringing this product back into the US market and are re-launching of PRE-PEN®."

PRE-PEN® is available in single unit ampules. A puncture (prick) skin test is read in 15 minutes. A positive result requires a wheal of 5mm in diameter. If the SPT is negative (a wheal of 4 mm or less), an intradermal test is placed in duplicate (raising a bleb of  3 mm). A positive result is at least a 5 mm wheal after 20 minutes.

Download PrePen Package Insert (PDF).



Official video by the manufacturer, ALK-Abello: Penicillin Allergy Skin Testing with PRE-PEN® for Allergists.

References:

Drug Allergy
Skin testing to penicillin. Ask the expert. AAAAI, 2009.

Non IgE-mediated reaction to penicillin - AAAAI - Ask the Expert, 2011.
Image source: Penicillin core structure, in 3D. Purple is variable group. Wikipedia, public domain.