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Human T-cell Leukemia Virus Type 1

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Human T-cell Leukemia Virus Type 2

Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)

Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica

HTLV I/II Confirmation and Differentiation

MP Diagnostics HTLV Blot 2.4

Sara Dionne, PhD

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens

Clinical Sites and the Reference Core-Lab will be masked of specimen disease state

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens

All clinical study data will be compiled and shared with investigators following database lock.

MP Biomedicals Asia Pacific Pte. Ltd.

MP Biomedicals, LLC

Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay

Susan Stramer, Ph.D

The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Dual Algorithm Post Market Clinical Study

Evaluation of the MP Diagnostics HTLV Blot 2.4

Individual patient data (IPD) was deidentified prior to sharing.

HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.

Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.

Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.

Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.

Supplemental testing algorithm performed by the CDPHL.

CDPHL Algorithm

The purpose of this study is:

1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.

This is a retrospective study designed to assess the validity and reproducibility of the MP Diagnostics IVD device, the HTLV Blot 2.4 (MP Blot), in various populations. The study will be conducted at three geographical distinct locations.

The validity of the MP Blot will be assessed by calculating the following:

1. Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
2. Percent positive agreement with CDPHL Algorithm on 200 EIA repeat reactive specimens

The sensitivity of the MP Blot will be evaluated by testing 200 known positive specimens. The study will be performed using three product lots at three clinical sites.

The reproducibility of the MP Blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study	NCT03226119	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	MP Diagnostics ...	18 Years -	MP Biomedicals, LLC
Dual Algorithm Post Market Clinical Study	NCT03146013	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	MP Diagnostics ...	18 Years -	MP Biomedicals, LLC
Evaluation of the MP Diagnostics HTLV Blot 2.4	NCT01467024	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	CDPHL Algorithm	18 Years -	MP Biomedicals, LLC

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