Division of Laboratory Medicine

Department of Pathology
Beth Israel Deaconess Medical Center
Harvard Medical School
Boston, MA 02215

New Method Evaluation: Hipro COVID-19 IgM/IgG Antibody Test

I. Statement of Purpose, Background, and Clinical Validity

A novel coronavirus, SARS-CoV-2 is a novel pathogen causing a severe respiratory infection,

named COVID-19. Since the first occurrence, this virus has rapidly spread globally, and caused
subsequently outbreaks in all countries, worldwide. On March 11th, 2020, the World Health Organization
(WHO) declared this virus as the cause of the COVID-19 pandemic. Since then, various measures have
been implemented on all levels of society in the United States to mitigate the further spread of this virus.
Since the recognition of this virus and its rapid spread, various novel in-vitro laboratory diagnostic test
methods have received EUA status. In order to respond to the needs during these pandemic times,
validation and implementation of rapid diagnostic tests for SARS-CoV-2 is necessary. Dr. Stefan Riedel,
Associate Medical Director of the Clinical Microbiology Laboratory reviewed the available diagnostic
test methods that are commercially available, and reviewed the pertinent literature and the respective
regulatory (FDA, CLSI, CAP) reference documents.

The Beth Israel Deaconess Medical Center (BIDMC) microbiology laboratories, including the
molecular microbiology laboratory, currently uses a various molecular assays, the Abbott Real-Time
SARS-CoV-2 assay on the m2000 analyzer and the Genmark Diagnostics ePlex SARS-CoV-2 RT-PCR
assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and/or oropharyngeal
swabs from patients suspected to have COVID-19 disease. These tests have received FDA EUA status
previously, and have been validated and implemented for use at BIDMC. These methods serve as the
comparator methods for the evaluation of serologic test methods for detection and confirmation of
infection of SARS-CoV-2 infection and COVID-19. Serologic assays are a valuable asset to the
molecular detection methods to further assess patients’ clinical status and course of the infection.
Furthermore, serologic testing provides additional information for the evaluation of asymptomatic or
sub-clinically, minimally symptomatic patients who can be managed on an ambulatory basis and may not
require immediate hospitalization. In addition, serologic studies support assessment of seroprevalence in a
particular patient population and potentially aid in further epidemiologic assessments of this ongoing
COVID-19 pandemic.

Therefore, at the BIDMC clinical microbiology laboratories, we decided to evaluate the

performance and potential clinical utility of various serologic testing methodologies. Specifically, here we
evaluated the Hipro Biotechnology’s COVID-19 IgM/IgG Antibody test kit (Colloidal Gold) for detection
of IgM and/or IgG antibodies in patient serum samples. We refer to the company’s package insert for
further specific technical information for this IgM/IgG antibody test kit.

II. Determination of Method Performance Characteristics

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 We analyzed results for IgG and IgM against SARS-CoV-2 using the Hipro Kit using discarded
clinical serum samples from current patients, hospitalized at BIDMC; the patients’ clinical history and
diagnosis was recorded. When available, confirmatory PCR testing for SARS-CoV-2 was documented.
SARS-CoV-2 PCT testing at BIDMC is performed on nasopharyngeal (NP) swabs, using the Abbott
m2000 SARS-CoV-2 RT-PCR assay (Abbott Diagnostics), or the ePlex SARS-CoV-2 RT-PCR assay
(GenMark Diagnostics). Additional testing for other respiratory pathogens from the NP swabs was
performed on a select number of patients, using the ePlex RP panel (Genmark Diagnostics).

Forty-one (41) discarded, recent clinical serum specimen samples from patients current
hospitalized at BIDMC were included for this evaluation. A total of 41 individual test were obtained for
the test kit.

Test interpretations for serology test results were correlated with the results of the SARS-CoV-2
PCR testing and classified according to the following categories:
• True Positive - TP
• True Negative - TN
• False Positive - FP
• False Negative - FN

Forty-one (41) individual samples were tested in singlicate, and 25 out of 41 samples were IgM
positive and 16 were IgM negative; 24 were IgG positive and 17 were IgG negative.

Based on correlation of test results from the test kit (N=41) with clinical and PCR diagnosis of
COVID-19 (as described above), we identified 23 TP, 2 FP, 12 TN, and 4 FN samples for the IgM test
component, and 24 TP, 0 FP, 14 TN, and 3 FN for the IgG test component. Based on these results, for the
IgM test component, the initial sensitivity is 85.2% and the initial specificity is 85.7%; for the IgG test
component, the sensitivity is 88.9% and the specificity is 100%.

Interpretation and analysis of the test results was adjusted for time of onset of symptoms (< 5
days) with respect to correlation of serology test results and PCR test results. With this adjustment, we
identified 23 TP, 2 FP, 12 TN, and 3 FN samples for the IgM test component, and 24 TP, 0 FP, 14 TN,
and 3 FN for the IgG test component. Based on these results, for the IgM test component, the adjusted
sensitivity is 88.5% and the adjusted specificity is 85.7%; for the IgG test component, the sensitivity is
88.9% and the specificity is 100%.

III. Analysis by combination of IgG/IgM results in relation to SARS-CoV-2 PCR results

This analysis has been calculated, excluding One (1) patient(s)/sample(s) that were positive
by PCR for SARS-CoV-2, but were identified to have had less than 5 days from the onset of
symptoms until samples were collected and tested. The results from this revised analysis are shown
below:

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 This pilot evaluation was performed between April 16th, 2020 and April 25th, 2020 at the clinical
microbiology laboratories at Beth Israel Deaconess Medical Center. The complete and individual data set
is available at Dr. Riedel’s laboratory at BIDMC. Ongoing larger scale evaluation of the kit is underway.

April 29th, 2020

______________________________________
Stefan Riedel, M.D., Ph.D., D(ABMM), FCAP

Associate Medical Director, Clinical Microbiology Laboratories

Beth Israel Deaconess Medical Center
Associate Professor, Pathology
Harvard Medical School

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