Posted 1/17/2019 by Jon Washburn, Staff Engineer, Lab Products

From our conversations with state public health lab directors, we know that resources are stretched. When new conditions are added to the newborn screening panel and budget is set, the lab still needs to implement changes to the workflow. Common questions:

• Do I have to hire a specially-trained tech?
• How much additional hands-on time is required?
• How long does it take to run the test?

Compare Methods of Newborn Screening for Pompe Disease & MPS I

For newborn screening of lysosomal storage disorders (including RUSP-approved Pompe disease and MPS I), let’s compare workflow impact of the two FDA-cleared tests: PerkinElmer NeoLSD™ on tandem mass spectrometry (MS/MS) and Baebies digital microfluidics platform SEEKER®

Training Requirements

NeoLSD: While newborn screening laboratories are very familiar with operation of metabolic MS/MS assays, NeoLSD requires several additional, intricate steps that are much more challenging than established MS/MS assays. See the workflow image to the right. In Step 7, the top layer of liquid within each well of the 96-well plate has to be transferred to a sampling plate. During this liquid-liquid extraction if the entire layer is not extracted, it can result in low enzyme activity values and increased risk of false positives. If any of the aqueous bottom layer is extracted, the test result is inaccurate and void.

SEEKER: No specialty skills required.

Hands-on Time

NeoLSD: Alongside unfamiliar workflow steps that require significant care, other post-incubation steps require substantial hands-on time. In Step 6, a microplate centrifuge capable of holding deep-well plates is required, which may be located on the other side of the lab or even across the hall. Multiple steps should be performed in a chemical hood, including Step 8 which requires the microplate evaporator to be located under the hood. With MS/MS plus these additional instruments needed, the likelihood of time lost to maintenance roadblocks increases.

SEEKER: 20 minutes hands-on time per 160 samples, all on a single lab bench. See for yourself in our workflow video.

Time to Result

NeoLSD: According to the assay protocol submitted for the NeoLSD FDA 510(k) application, the total time to result with NeoLSD is around two full working days. Attempts to reduce the NeoLSD assay time would require you to perform full method validation due to off-label use. And even with a faster run-time, results would not be delivered until the autosampler completes (likely overnight).

SEEKER: Results in under 3 hours.