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Semi-Quantitative IgG and IgM Anti-Coccidioides Antibody Assay for Diagnosis of Coccidioidomycosis

Case report. A healthy young woman from California presented with low-grade fever, cough, arthralgias and painful bumps on her legs of two weeks duration. Temperature was 100.6°F and examination showed tender erythematous nodules on both legs. Chest radiograph demonstrated right hilar lymphadenopathy and a patchy infiltrate in the right lower lobe. Pertinent laboratory findings included 12% eosinophilia. Coccidioidomycosis was suspected but the Coccidioides antigen and antibody tests (immunodiffusion [ID] and complement fixation [CF]) were negative.

Question. Do negative antigen and antibody test exclude coccidioidomycosis?

Answer. No. The diagnosis was acute pulmonary coccidioidomycosis (APC). Antigen is detected mostly in immunocompromised patients with disseminated coccidioidomycosis [1, 2]. ID and CF are negative in 40-60% of patients with APC [3]. The diagnosis in this case was based on positive IgG and IgM antibodies in a new EIA [4] (Journal of Clinical Microbiology Feb 2017, 55 (3) 893-901). The IgG level was > 80 units and the IgM level were 73 units six weeks after onset of symptoms and declined over the next 16 months (Figure 1).

> READ MORE ON PG. 3

INSIGHTS

ISSUE 2 | 2019 JULY

IN THIS ISSUECustomer & Technical Service UpdatesFeatured Article Company News Meetings of Interest

FEATURED ARTICLE

COMPANY NEWS

We are pleased to welcome Dr. Kairong Li to MiraVista Diagnostics. He brings over 20 years of experience in life sciences to his new role as Senior Research Scientist, where his talents will be utilized to expand MiraVista’s scope into molecular diagnostics.

> READ MORE ON PG. 5

Meet Kairong Li, Ph.D.Senior Research Scientist

HEADQUARTERS4705 Decatur Blvd. | Indianapolis, Indiana 46241, USA miravistalabs.com

866.490.9316

Do you accept specimens on Saturdays?ANSWER

Yes, we accept shipments on Saturdays and offer Histoplasma and Blastomyces antigen EIA tests on Saturdays.ANSWER

BUSINESS HOURS OF OPERATION:Monday: 8:00am – 5:00pm EST

CLINICAL TESTING HOURS OF OPERATION:

Monday: 8:00am – 5:00pm ESTTuesday – Friday: 8:00am – 11:00pm EST

Saturday: 8:30am – 5:00pm EST

CLINICAL CONSULTATION HOURS:Monday – Friday: 10:00am to 4:30pm EST

CUSTOMER & TECHNICAL SERVICE UPDATES

What are your hours of operation?

What specimen types do you test?

Test Specimen Type*Antigen: Histo, Blasto, Cocci Urine, serum, BAL, CSF, plasmaAntigen: Asper Serum, CSF, BALAntigen: Crpto LA Serum, CSFAntibody EIA Serum, plasma, CSFAntibody ID Serum, plasma, CSFBeta D Glucan Serum, CSF

FREQUENTLY ASKED QUESTION FROM CLIENTS

ANSWER

ANSWERa. Specimens should be shipped FedEx Priority Overnight or UPS Next Day.

b. 2-day delivery can be selected to reduce shipping costs if the delay in result time is acceptable to healthcare provider. If the client cannot send a specimen in time to meet the test date deadline for assays that are not run daily, (Antibody assay, FID), 2-day shipping may be a reasonable option for cost reduction.

c. Obtain a tracking number from your courier to ensure delivery of your shipment.

d. Schedule delivery:

1. For same day testing, 8:00am –10:30am EST. Use FedEx Priority Overnight or UPS Next Day Air. Note: not all tests are run daily. See chart.

2. Saturday 8:00 am – 10:30 am EST, select Saturday Delivery when creating the shipping request.

How do I ship the specimen?

FEATURED ARTICLE

The study evaluating the new EIA included 103 patients with pulmonary (70%) or disseminated (30%) coccidioidomycosis. Most had been ill for several months and 75% were receiving antifungal therapy.

Sensitivity of EIA was higher than ID or CF (Table 1) and not affected by disease manifestation (p=0.308), immune status (p=0.498) or antifungal therapy (p=.760).

IgG specificity was 91% and IgM was 97% in healthy persons from areas where 70% are skin test positive. Cross-reactivity occurred in 32% of patients with histoplasmosis and 8% with blastomycosis. In histoplasmosis cases, antibody levels are lower in the Coccidioides EIA compared to the Histoplasma antibody EIA.

Moreover, IgG and IgM levels are highly reproducible, which is essential for quantification (Figure 2). Quantification facilitates determination of seroconversion and antibody clearance during treatment. Summary. The new antibody EIA offers major advancement in diagnosis and management of coccidioidomycosis. Cross reactions can be resolved by comparison of antibody levels to the related fungi. Background IgG levels of 10-20 units occur in about 10% of healthy subjects from highly endemic areas, overlapping those in patients with recent coccidioidomycosis. Repeat testing may differentiate active from past infection. Some cases are negative by EIA but positive by ID, supporting testing by both methods.

Semi-Quantitative IgG and IgM Anti-Coccidioides Antibody Assay for Diagnosis of Coccidioidomycosis

HEADQUARTERS4705 Decatur Blvd. | Indianapolis, Indiana 46241, USA miravistalabs.com

866.490.9316

Sensitivity Comparing Manifestation and Immunity

Disease EIA ID CFDisseminated-31 84% 71% 68%

Pulmonary-72 92% 54% 65%

Immunocompromise EIA ID CFYes-30 83% 50% 65%

No-73 90% 63% 65%

Table 1

Figure 1

(continued)

Reference List

(1) Durkin M, Connolly P, Kuberski T, et al. Diagnosis of Coccidioidomycosis with Use of the Coccidioides Antigen Enzyme Immunoassay. Clin Infect Dis 2008 Oct 15; 47(8):e69-e73.

(2) Durkin M, Estok L, Hospenthal D, et al. Detection of coccidioides antigenemia following dissociation of immune complexes. Clin Vaccine Immunol 2009 Oct; 16(10):1453-6.

(3) Blair JE, Chang YH, Cheng MR, et al. Characteristics of patients with mild to moderate primary pulmonary coccidioidomycosis. Emerg Infect Dis 2014 Jun; 20(6):983-90.

(4) Malo J, Holbrook E, Zangeneh T, et al. Enhanced Antibody Detection and Diagnosis of Coccidioidomycosis with the MiraVista IgG and IgM Detection Enzyme Immunoassay. J Clin Microbiol 2017 Mar; 55(3):893-901.

HEADQUARTERS4705 Decatur Blvd. | Indianapolis, Indiana 46241, USA miravistalabs.com

866.490.9316

Figure 2

COMPANY NEWS

HEADQUARTERS4705 Decatur Blvd. | Indianapolis, Indiana 46241, USA miravistalabs.com

866.490.9316

We are pleased to welcome Dr. Kairong Li to MiraVista Diagnostics. He brings over 20 years of experience in life sciences to his new role as Senior Research Scientist, where his talents will be utilized to expand MiraVista’s scope into molecular diagnostics.

After earning his Ph.D. degree from Peking University, he moved to the United States to study genetic brain development and genetic disorders using the latest technologies in microbiology, molecular biology, genetics, genomics, biochemistry, etc. During this period, he published nearly twenty research papers in peer-reviewed journals and received many awards, such as the “Youth Investigator Award” from the Children’s Tumor Foundation. Prior to joining our company, he worked at BioGX to design and

develop high complexity molecular microbial diagnostic products utilizing real-time PCR and Next Generation Sequencing-based technologies. He took a leading role in multiple cross-departmental teams to improve product transfer, manufacturing, and quality control for new product development.

We’re thrilled to have him join our team!

Meet Kairong Li, Ph.D.Senior Research Scientist

Progress on our Building Expansion

HEADQUARTERS4705 Decatur Blvd. | Indianapolis, Indiana 46241, USA miravistalabs.com

866.490.9316

MEETINGS OF INTEREST

MiraVista Diagnostics attended:> Dr. Wheat hosted a dinner with colleagues to discuss “New Developments in the Diagnosis of Coccidioidomycosis” | June 6, 2019, Phoenix, AZ

Upcomming events: > American Association of Clinical Chemistry, 71st AACC Annual Scientific Meeting & Clinical Lab Expo | August 4-8, Anaheim, CA. > Infectious Disease Society of America, ID Week | October 2-6, Washington, DC.