# Stabilization of the RNA Complement of Enveloped Viruses: Beta Testing and Manufacturing Scale-up of a Novel Filter Paper Product for the Field Collection of Dried Blood Spots

> **NIH NIH R44** · GENTEGRA, LLC · 2021 · $1,000,000

## Abstract

Abstract.
In 1960, filter paper based sample collection with Guthrie Cards revolutionized blood-based
screening of small molecule biomarkers of birth defect: via the collection of heal stick blood
directly onto filter paper, to form a dried blood spot (DBS). In the 2000's, Guthrie Card
(Whatman 903) DBS sample collection was extended (by this Team and many others) to DNA
biomarkers and to analysis of blood-borne bacteria and DNA viruses.
That substantial success with DNA, has shifted research to the “loftier” goal of collecting and
preserving the highly unstable RNA complement of DBS: with emphasis on tools to enable the
refrigeration-free collection of blood. This supports screening of RNA virus infections. Numerous
publications have subsequently emerged, to establish the use of Whatman 903 DBS for HIV,
Zika and other emerging RNA viruses.
The Good News is, those several published studies have confirmed viral RNA can be
recovered by quantitative RT-PCR (qRT-PCR) from DBS obtained from a finger prick, if
collected and stored “appropriately”.
The Bad News is, published studies have shown that adequate RNA stability can be obtained
only under unrealistic conditions (4C, -20C storage). Under conditions of tropical ambient
temperatures (30C-40C) those studies have concluded that DBS collection and transport does
not work: i.e. RNA degrades beyond the qRT-PCR detection limit within less than a week.
This Phase IIB SBIR is focused on beta testing of a pair of fundamentally new filter paper based
products (GT-A & GT-B) created by the Applicant Team. For the first time, it will be possible to
collect/ship viremic blood under realistic tropical conditions; 2 weeks of continuous 40C storage,
yielding RNA for standard qRT-PCR analysis. The core technology exploited in this Phase IIB,
originally developed by GenTegra with DARPA funding, uses two different approaches to viral
RNA preservation: GT-A, to stabilize the structure of the virus in a DBS, thus exploiting the
natural protection afforded by that intact structure; and GT-B, to instantly lyse the virus,
simultaneously introducing into the DBS, a novel panel of nuclease and free radical inhibitors.
Phase IIB beta test is to be validated by two top labs: ATCC (for Zika) and Stanford (for HIV-1),
for both technologies. GenTegra will in parallel test with other viruses. Upon completion of this
Phase IIB, one or both products will be ready for international sales & marketing, supported by
the Existing collaboration between GenTegra and Ahlstrom-Munksjö.

## Key facts

- **NIH application ID:** 10153685
- **Project number:** 5R44AI132032-05
- **Recipient organization:** GENTEGRA, LLC
- **Principal Investigator:** Nan Su
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2017-03-08 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10153685

## Citation

> US National Institutes of Health, RePORTER application 10153685, Stabilization of the RNA Complement of Enveloped Viruses: Beta Testing and Manufacturing Scale-up of a Novel Filter Paper Product for the Field Collection of Dried Blood Spots (5R44AI132032-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10153685. Licensed CC0.

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