Assure COVID-19 IgG/IgM Rapid Test Device Materials Provided start the timer.

• Individually packed test devices • Buffer

• Disposable pipettes • Package insert
For Emergency Use Authorization Only
• Negative control • Positive control
For prescription use only
For in vitro Diagnostic Use Only.
External Negative and Positive Control
INTENDED USE
Negative controls are lyophilized human serum samples and positive controls are lyophilized IgG and IgM
against SARS-CoV-2. Two negative control vials are supplied. Reconstitute each negative control vial
The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay
with 30 µL purified water. Transfer one reconstituted 30 µL negative control to the positive control vial
intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in
to make ready-to-use positive control. Controls can be used like a serum sample. Store reconstituted
human venous whole blood (sodium EDTA), serum or plasma (sodium EDTA). The Assure COVID-19
controls at 4oC.
IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive
immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how
Materials Required but Not Provided
long antibodies persist following infection and if the presence of antibodies confers protective immunity. • Clock, timer or stopwatch • Specimen collection container
The Assure COVID-19 IgG/IgM Rapid Test Device should not be used to diagnose acute SARS-CoV-2
infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement WARNING AND PRECAUTIONS
Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform moderate or high
complexity tests. • For use under an Emergency Use Authorization Only. For Venous Whole Blood Specimens
Results are for the detection of SARS-CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 • For in vitro Diagnostic Use Only. a) Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen
are generally detectable in blood several days after initial infection, although the duration of time • This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA entering the bubble of disposable pipette) and transfer one drop of the specimen into the specimen
antibodies are present post-infection is not well characterized. Individuals may have detectable virus for use by laboratories certified under CLIA, that meet requirements to perform moderate or high well of the test device, then add 2 drops of buffer and start the timer.
present for several weeks following seroconversion. complexity tests.
Laboratories within the United States and its territories are required to report all positive results to the • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2,
appropriate public health authorities. not for any other viruses or pathogens. This test is only authorized for the duration of the declaration
The sensitivity of Assure COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-
testing for SARS-CoV-2 is necessary. 3(b)(1), unless the authorization is terminated or revoked sooner.
False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to cross-reactivity • Read the Package Insert prior to use. Directions should be read and followed carefully.
from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation • Do not use kit or components beyond the expiration date.
of positive results should be considered using second, different IgG or IgM assay. • The device contains material of animal origin and should be handled as a potential biohazard. Do not
The Assure COVID-19 IgG/IgM Rapid Test Device is only for use under the Food and Drug use if pouch is damaged or open.
Administration’s Emergency Use Authorization. • Test devices are packaged in foil pouches that exclude moisture during storage. Inspect each foil
pouch before opening. Do not use devices that have holes in the foil or where the pouch has not been
SUMMARY AND EXPLANATION completely sealed. Erroneous result may occur if test reagents or components are improperly stored.
• Do not use the Buffer if it is discolored or turbid. Discoloration or turbidity may be a sign of microbial
Coronaviruses are a large family of viruses that are common in many different species of animals, contamination.
including camels, cattle, cats, and bats. • All patient specimens should be handled and discarded as if they are biologically hazardous. All RESULT INTERPRETATION
The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause severe respiratory syndrome in specimens must be mixed thoroughly before testing to ensure a representative sample prior to testing. For Assure COVID-19 IgG/IgM Test:
humans, and the other four human coronaviruses (HCoV-NL63, HCoV-229E, HCoV-OC43 and HKU1) • Failure to bring specimens and reagents to room temperature before testing may decrease assay
induce only mild upper respiratory diseases in immunocompetent hosts, although some of them can cause sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield false IgM and IgG Positive:*The colored line in the control region (C)
severe infections in infants, young children and elderly individuals1,2,3. negative test results. changes from blue to red, and two colored lines should appear in IgG and
COVID-19 is the disease associated with SARS-CoV-2, which was identified at the end of 2019. • Avoid skin contact with buffer containing sodium azide which is a skin irritant. IgM test regions. The color intensities of the lines do not have to match.
Coronaviruses cause respiratory and intestinal infections in animals and humans1. • If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening The result is positive for IgM and IgG antibodies.
The virus is transmitted mainly via respiratory droplets that people sneeze, cough, or exhale. The criteria recommended by public health authorities, specimens should be collected with appropriate
incubation period for COVID-19 is currently estimated at between two and 14 days. Common symptoms infection control precautions and sent to state or local health departments for testing.
of COVID-19 infection include fever, cough and respiratory symptoms such as shortness of breath and • Humidity and temperature can adversely affect results. IgG Positive:*The colored line in the control region (C) changes from
breathing difficulties. More serious cases develop severe pneumonia, acute respiratory distress syndrome, blue to red, and a colored line appears in the IgG test region. The result is
sepsis and septic shock that can lead to the death of the patient. People with existing chronic conditions STORAGE AND STABILITY positive for COVID-19 virus specific-IgG antibodies.
seem to be more vulnerable to severe illness.
Detection of IgM indicates recent infection and can be used for early diagnosis of infection. IgG antibodies • Store the Assure COVID-19 IgG/IgM Rapid Test Device at 2~30℃when not in use.
gradually appear and increase in the late stage of infection, and the Assure COVID-19 IgG/IgM Rapid • DO NOT FREEZE. IgM Positive:*The colored line in the control region (C) changes from
Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM • Kit contents are stable until the expiration dates marked on their outer packaging and containers. blue to red, and a colored line appears in the IgM test region. The result is
antibody. It will provide a presumptive diagnosis of COVID-19. • Perform testing immediately after specimen collection. Serum and plasma specimens may be stored at 2- positive for COVID-19 virus specific-IgM antibodies.
8°C for up to 7 days. For long term storage, serum or plasma specimens should be kept below -20°C.
PRINCIPLE Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days after
collection. Do not freeze whole blood specimens. Negative: The colored line in the control region (C) changes from blue to
The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow immunochromatographic assay for • Containers containing anticoagulants such as sodium EDTA, should be used for whole blood storage. red. No line appears in IgM or IgG test regions.
the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. This test uses anti- • Bring specimens to room temperature prior to testing. Frozen serum or plasma specimens must be
human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-mouse IgG (control line completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
C) immobilized on a nitrocellulose strip. The conjugate pad contains recombinant SARS-CoV-2 antigen • If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation
(antigen is recombinant Nucleocapsid Protein and Spike Protein (S1)) conjugated with colloid gold. of etiological agents.
During testing, the specimen binds with SARS-CoV-2 antigen- conjugated gold colloid coated particles
in the test cassette. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG TEST PROCEDURE
antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This
Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to Invalid: Control line (C) is still completely or partially blue, and fails to
complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line
testing. completely change from blue to red. Insufficient buffer volume or
of the corresponding immobilized antibody (anti-human IgM &/or anti-human IgG) the complex is trapped
incorrect procedural techniques are the most likely reasons for control line
forming a red line which confirm a reactive test result. Absence of a red line in the test region indicates a 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch
failure. Review the procedure and repeat the procedure with a new test
non-reactive test result. and use it as soon as possible.
2. Place the test device on a clean and level surface. Note: There should be a blue line in the control device. If the problem persists, discontinue using the test kit immediately
To serve as a procedural control, a red line will always appear in the control line region, indicating that
region (next to “C”), discard the device if there is no blue line. and contact your local distributor.
the proper volume of specimen has been added and membrane wicking has occurred.
The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or 3. Label the test with patient or control identification.
IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves 4. Add the specimens.
as a procedural control, indicating that membrane wicking is working.
For Serum or Plasma Specimens
REAGENTS AND MATERIALS NOTE:
a) Using the provided disposable pipette, draw the specimen up to the Fill Line, and transfer all the
specimen (appr. 5 µL) into the specimen well of the test device, then add 2 drops of buffer and 1. The color intensity in the test region may vary depending on the concentration of analytes present
in the specimen. Therefore, any shade of color in the test region should be considered positive.

Revision 1.2 Effective date: 2020-047-06 Page 1/3

 Note that this is a qualitative test only, and cannot determine the concentration of analytes in the their intent to run your product prior to initiating testing.
Combined Sites (Serum +
specimen. 4. Authorized laboratories using your product will have a process in place for reporting test results to 105 105 100% 96.5%-100%
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely healthcare providers and relevant public health authorities, as appropriate. Blood)
reasons for control band failure. 5. Authorized laboratories will collect information on the performance of your product and report to
DMD/OHT7-OIR/OPEQ/CDRH（via email: CDRH-EUA-Reporting@fda.hhs.gov）and Assure Tech
QUALITY CONTROL (Hangzhou Co., Ltd). (via email: contact@direagent.com) any suspected occurrence of false reactive or
false non-reactive results and significant deviations from the established performance characteristics of Table 3. IgM PPA for the Assure COVID-19 IgG/IgM Rapid Test Device
Internal Procedural Controls your product of which they become aware.
The Assure COVID-19 IgG/IgM Rapid Test Device has built-in (procedural) controls. Each test device 6. All laboratory personnel using your product must be appropriately trained in immunoassay techniques # PCR Assure COVID-19 IgG/IgM Rapid Test
has an internal standard zone to ensure proper sample flow. The user should confirm that the blue band and use appropriate laboratory and personal protective equipment when handling this kit and use your Days post
Positive Device
should be always located at the “C” region before testing, and the red band should be always present product in accordance with the authorized labeling. All laboratory personnel using the assay must also be
Site symptom
before result interpretation. trained in and be familiar with the interpretation of results of the product. at any
External Positive and Negative Controls 7. Assure Tech. (Hangzhou Co., Ltd), authorized distributors, and authorized laboratories using your #Positive
onset PPA 95%CI
Good laboratory practice suggests testing positive and negative external controls to ensure that the test product will ensure that any records associated with this EUA are maintained until otherwise notified by time Results
reagents are working and that the test is correctly performed. FDA. Such records will be made available to FDA for inspection upon request.
*The Letter of Authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement ≤7 8 8 100% 67.6%-100%
LIMITATIONS OF THE TEST Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high
For use under an Emergency Use Authorization Only complexity tests” as “authorized laboratories”.
(Site 1+3+4) 8-14 15 13 86.7%
62.1%-

1. Use of the Assure COVID-19 IgG/IgM Rapid Test Device is limited to laboratory personnel who PERFORMANCE CHARACTERISTICS 96.3%
have been trained. Not for home use. Serum
2. The Assure COVID-19 IgG/IgM Rapid Test Device is for in vitro diagnostic use only. The test 65.3%-
Clinical Evaluation ≥15 25 21 84%
should be used for the detection of SARS-CoV-2 antibodies in whole blood, serum or plasma
93.6%
specimens only. Neither quantitative value nor the rate of increase in SARS-CoV-2 antibody
Study I
concentration can be determined by this qualitative test. ≤7 1 1 100% 20.7%-100%
Total of 61 positive and 105 negative serum or venous whole blood samples were collected at 4 different (Site 2)
3. The Assure COVID-19 IgG/IgM Rapid Test Device is not validated for finger stick blood.
study sites. These samples were tested with both RT-PCR method for SARS-CoV-2 infection and Assure
4. The Assay Procedure and the Interpretation of Assay Result must be followed closely when testing Venous Whole 8-14 3 3 100% 43.9%-100%
COVID-19 IgG/IgM Rapid Test device for antibodies. The obtained sensitivity and specificity results are
for the presence of SARS-CoV-2 virus specific antibodies in the serum, plasma or whole blood
summarized in following tables.
specimen from individual subjects. For optimal test performance, proper sample collection is Blood ≥15 9 9 100% 70.1%-100%
critical. Failure to follow the procedure may give inaccurate results. Table 1. IgG PPA for the Assure COVID-19 IgG/IgM Rapid Test Device
5. Reading test results earlier than 10 minutes after the addition of Buffer may yield erroneous results. Combined Sites
Do not interpret the results after 20 minutes. # PCR Assure COVID-19 IgG/IgM Rapid Test 80.2%-
6. The Assure COVID-19 IgG/IgM Rapid Test Device will only indicate the presence of SARS-CoV- Days post (Serum + - 61 55 90.2%
Positive Device 95.4%
2 antibodies in the specimen and should not be used for the diagnosis of SARS-CoV-2. Blood)
7. In the early onset of symptom, anti-SARS-Cov-2 IgM and IgG antibody concentrations may be Site symptom
at any #Positive
below detectable levels. onset
8. A high dose “hook effect” may occur where the color intensity of test band decreases as the PPA 95%CI
time Results
concentration of anti-SARS-CoV-2 IgG/IgM increases. If a “hook effect” is suspected, dilution of Table 4. IgM NPA for the Assure COVID-19 IgG/IgM Rapid Test Device
specimens may increase color intensity of the test band. 52.9%-
9. Results from immunosuppressed patients should be interpreted with caution. ≤7 8 7 87.5% Assure COVID-19 IgG/IgM Rapid Test
10. As with all diagnostic tests, all results must be interpreted together with other clinical information 97.8%
available to the physician. (Site 1+3+4) # PCR Device
11. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis 62.1%- Site
Serum 8-14 15 13 86.7% Negative #Negative
for patient management decisions, IgM antibodies may not be detected in the first few days of
infection; the sensitivity of the Assure COVID-19 IgG/IgM Rapid Test Device early after infection 96.3% NPA 95%CI
Results
is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity
≥15 25 25 100% 86.7%-100%
from pre-existing antibodies or other possible causes. Samples with positive results should be (Site 1+3+4) 92.7%-
confirmed with alternative testing method(s) and clinical findings. (Site 2) ≤7 1 1 100% 20.7%-100% 96 94 97.9%
12. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the Serum 99.4%
specimen is below the detection limits of the assay, or the antibodies that are detected are not Venous Whole 8-14 3 3 100% 43.9%-100%
present during the stage of disease in which a sample is collected. (Site 2)
13. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, Blood ≥15 9 9 100% 70.1%-100% 9 9 100% 70.1%-100%
such as coronavirus HKU1, NL63, OC43, or 229E. Venous Whole Blood
14. Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection Combined Sites
86.5%- Combined Sites (Serum + 93.3%-
or to inform infection status. 105 103 98.1%
(Serum + - 61 58 95.1%
15. Not for the screening of donated blood. Blood) 99.5%
98.3%
Blood)
The sensitivity of the test is impacted after being open for one hour-the intensity of the T line becomes
weak. Testing must be performed within one hour after opening the pouch.
Study II: Independent Clinical Agreement Validation
Table 2. IgG NPA for the Assure COVID-19 IgG/IgM Rapid Test Device The COVID-19 IgG/IgM Rapid Test Device from Assure Tech. (Hangzhou) Co., Ltd. was tested on 2020-
Conditions of Authorization for the Laboratory 06-15 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National
Assure COVID-19 IgG/IgM Rapid Test Cancer Institute (NCI). The test was validated against a panel of previously frozen samples consisting of
The Assure COVID-19 IgG/IgM Rapid Test Device Letter of Authorization, along with the authorized
30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples.
Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and other authorized # PCR Device
Site Each of the 30 antibody-positive samples was confirmed with a nucleic acid amplification test (NAAT)
labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-
Negative and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of
2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas. #Negative
NPA 95%CI antibodies in the samples was confirmed by several orthogonal methods prior to testing with the Assure
Authorized laboratories using the Assure COVID-19 IgG/IgM Rapid Test Device (“your product” in the
Results COVID-19 IgG/IgM Rapid Test Device. The presence of IgM and IgG antibodies specifically was
conditions below), must adhere to the Conditions of Authorization indicated in the Letter of Authorization
confirmed by one or more comparator methods. Antibody-positive samples were selected at different
as listed below:
(Site 1+3+4) antibody titers.
1. Authorized laboratories* using your product will include the test result reports, all authorized Fact 96 96 100% 96.2%-100% All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected
Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may Serum without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from
be used, which may include mass media.
HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the Assure COVID-19
2. Authorized laboratories using your product will use your product as outlined in the Instructions for Use. (Site 2) IgG/IgM Rapid Test Device. Confidence intervals for sensitivity and specificity were calculated per a
Deviations from the authorized procedures, including the authorized clinical specimen types, authorized 9 9 100% 70.1%-100%
Venous Whole Blood score method described in CLSI EP12-A2 (2008).
control materials, authorized other ancillary reagents and authorized materials required to use your product
For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate
are not permitted.
among antibody-negative samples with HIV was statistically higher than the false positive rate among
3. Authorized laboratories that receive your product will notify the relevant public health authorities of

Revision 1.2 Effective date: 2020-047-06 Page 2/3

antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive Anticoagulants
rates was calculated per a score method described by Altman). The results and data analysis are shown in
EDTA (sodium salt) 3.4 µmol/L
the Tables 5 and 6 below.
Abnormal blood sample
Table 5. Summary Results Visual hemolysis (Hemoglobin) 20 g/dL
Assure COVID-19 Comparator Method
Icteric (Bilirubin) 5 mg/dL
IgG/IgM Rapid Test Positive Negative Negative, Total
Device (IgM/IgG) + (IgM/IgG) - HIV+ Lipemic (Triglycerides) 500 mg/dL
Positive IgM+/IgG+ 27 0 0 27 Common medicines
IgM+, IgG- 3 1 0 4 Acetylsalicylic acid 3.62 mmol/L
IgM-, IgG+ 0 0 0 0
Ascorbic acid (Vitamin C) 342 µmol/L
Negative IgM-/IgG- 0 69 10 79
Total (n=110) 30 70 10 110 Amoxicillin 206 µmol/L
Fluconazole 245 µmol/L
Table 6. Summary Statistics Ibuprofen 2425 µmol/L
Measure Estimate Confidence Interval Loratadine 0.78 µmol/L
IgM+ Sensitivity (PPA) (30/30) 100% (88.7%; 100%) Nadolol 3.88 µmol/L
IgM- Specificity (NPA) (79/80) 98.8% (93.3%; 98.8%) Naproxen 2170 µmol/L
IgG+ Sensitivity (PPA) (27/30) 90.0% (74.4%; 96.5%) Paroxetine 3.04 µmol/L
IgG- Specificity (NPA) (80/80)100% (95.4%; 100%)
Anti-malarial medicines
Combined Sensitivity (30/30) 100% (88.7%; 100%)
Combined Specificity (79/80) 98.8% (93.3%; 98.8%) Quinine 148 µmol/L
Combined PPV for prevalence = 5% 80.8% (40.9%; 96%) Anti-tuberculosis medicines
Combined NPV for prevalence = Rifampicin 78.1 µmol/L
100% (99.4%; 100%)
5%
Isoniazid 292 µmol/L
(0/10) 0%
Cross-reactivity with HIV+ ----------------- Ethambutol 58.7 µmol/L
not detected Common consumables
Cross Reactivity Coffee (caffeine) 308 µmol/L
There was no cross-reactivity with plasma specimens meeting the disease state shown below. No IgM or Alcohol (ethanol) 86.8 mmol/L
IgG false positive results were observed with the following potential cross-reactants:
LITERATURE REFERENCES
Table 7. Cross-reactivity Study Data of Assure COVID-19 IgG/IgM Rapid Test Device
Number of Number of 1. Masters, P. S. & Perlman, S. in Fields Virology Vol. 2 (eds Knipe, D. M. & Howley, P. M.) 825–
Conditions samples Conditions 858 (Lippincott Williams & Wilkins, 2013).
samples
2. Su, S. et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends
Anti-HAV IgM + 5 Lyme disease+ 5 Microbiol. 24, 490–502 (2016).
Anti-HEV IgG + 2 P. falciparum + 5 3. Forni, D., Cagliani, R., Clerici, M. & Sironi, M. Molecular evolution of human coronavirus
HBsAg + 5 P. vivax + 5 genomes. Trends Microbiol. 25, 35–48 (2017).
4. Kan, B. et al. Molecular evolution analysis and geographic investigation of severe acute
Anti-HCV + 5 Toxoplasma IgM + 5 respiratory syndrome coronavirus-like virus in palm civets at an animal market and on farms. J.
Anti-HIV + 5 HAMA + 1 Virol. 79, 11892–11900 (2005).
Anti-Rubella IgM + 5 RF + 5 5. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat,
South Africa. Emerg. Infect. Dis. 19, 1697–1699 (2013).
Anti-CMV IgM + 5 ANA+ 5 6. “Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated
Anti-HSV-I IgM + 5 Anti-Influenza A IgM + 3 with Coronavirus Disease 2019 (COVID-19)” https://www.cdc.gov/coronavirus/2019-
Anti-HSV-II IgM + 5 Anti-Influenza B IgM + 1 nCoV/lab/lab-biosafety-guidelines.html.
GLOSSARY OF SYMBOLS
EBV IgM + 4 Anti-RSV IgM + 3
Anti-Dengue IgM + 5 Legionella pneumophila IgM+ 2 ρ Catalog number 8 Temperature limitation
Anti-Yellow fever + 5 Anti-Adenovirus IgM + 1 ι Consult instructions for use Λ Batch code
5 Anti-Mycoplasma pneumonia 3 Ι In vitro diagnostic medical device ε Use by
Anti-Zika IgG +
IgM + µ Manufacturer σ Do not reuse

5 Anti-Chlamydia pneumonia 3
Chagas Ab+
IgM + Manufactured by:
4 Anti-Chlamydia pneumonia 2 Assure Tech. (Hangzhou) Co., Ltd.
Anti-Syphilis IgG + 2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road,
IgG + Gongshu District, Hangzhou, Zhejiang 310011, China
Anti-Tuberculosis + 5 Measles IgG + 1
www.assurelabs.com
Typhoid IgM + 5 Mumps IgG + 1 contact@diareagent.com
Customer Service Phone: 1-800-618-5829
Service date/hours: Monday through Friday 9:00 AM to 5:00 PM CST
Interfering Substances
The assay performance of COVID-19 IgG/IgM Rapid Test Device is not affected by substances at
concentrations listed below.

Table 8. Interference Study Data of Assure COVID-19 IgG/IgM Rapid Test

Interfering substances Concentration of analytes
Blood analytes
Albumin 5 g/dL

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