Assure COVID-19 IgG/IgM Rapid Test Device • Sterile safety lancet • Alcohol Prep pad entering the bubble

• Alcohol Prep pad entering the bubble of disposable pipette) and transfer one drop of the specimen into the specimen
well of the test device, then add 2 drops of buffer and start the timer. Adding more or less drops of
Optional Materials specimen may lead to incorrect results. Adding 1 drop of buffer or more than 4 drops of buffer
• External Negative and Positive control (Available upon request) may lead to incorrect results.
For Emergency Use Authorization Only
For prescription use only
For in vitro Diagnostic Use Only. External Negative and Positive Control
Negative controls are lyophilized human serum samples and positive controls are lyophilized IgG and
Due to the risk of false positive results, confirmation of positive results should be considered using IgM against SARS-CoV-2. Two negative control vials are supplied. Reconstitute each negative control
second, different IgG or IgM assay. vial with 30 µL purified water. Transfer one reconstituted 30 µL negative control to the positive control
vial to make ready-to-use positive control. Controls can be used like a serum sample. Store reconstituted
INTENDED USE controls at 4℃.
The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic Materials Required but Not Provided
immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to • Clock, timer, or stopwatch • Specimen collection container
SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and
fingerstick whole blood. The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an WARNING AND PRECAUTIONS
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 long antibodies persist following infection and if the • For use under an Emergency Use Authorization Only.
• For in vitro Diagnostic Use Only. For Fingerstick Whole Blood
presence of antibodies confers protective immunity. The Assure COVID-19 IgG/IgM Rapid Test Device
should not be used to diagnose acute SARS-CoV-2 infection. • This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA a) Clean the puncture site with the alcohol prep pad provided
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical for use by laboratories certified under CLIA, that meet requirements to perform moderate or high
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to complexity tests.
perform moderate or high complexity tests. • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2,
not for any other viruses or pathogens. This test is only authorized for the duration of the declaration
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for
(POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and
Compliance, or Certificate of Accreditation. Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Read the Package Insert prior to use. Directions should be read and followed carefully. b) Carefully remove the cap from the safety lancet. Push the safety lancet firmly against the puncture
Results are for the detection of SARS-CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 • Do not use kit or components beyond the expiration date. site until it pricks the finger.
are generally detectable in blood several days after initial infection, although the duration of time • The device contains material of animal origin and should be handled as a potential biohazard. Do
antibodies are present post-infection is not well characterized. Individuals may have detectable virus not use if pouch is damaged or open.
present for several weeks following seroconversion. • Test devices are packaged in foil pouches that exclude moisture during storage. Inspect each foil
Laboratories within the United States and its territories are required to report all positive results to the pouch before opening. Do not use devices that have holes in the foil or where the pouch has not
appropriate public health authorities. been completely sealed.Erroneous result may occur if test reagents or components are improperly
The sensitivity of Assure COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. stored.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct • Do not use the Buffer if it is discolored or turbid. Discoloration or turbidity may be a sign of
testing for SARS-CoV-2 is necessary. microbial contamination.
• All patient specimens should be handled and discarded as if they are biologically hazardous. All c) Using the provided disposable pipette, draw the specimen above the fill line(avoid the
False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to specimenentering the bubble of disposable pipette) and transfer one drop (equivalent to 10µL) of
cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive specimens must be mixed thoroughly before testing to ensure a representative sample prior to
testing. the specimen into the specimen well of the test device, then add 2 drops of buffer and start the
results, confirmation of positive results should be considered using second, different IgG or IgM assay. timer. Adding more or less drops of specimen may lead to incorrect results. Adding 1 drop of
The Assure COVID-19 IgG/IgM Rapid Test Device is only for use under the Food and Drug • Failure to bring specimens and reagents to room temperature before testing may decrease assay
sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield buffer or more than 4 drops of buffer may lead to incorrect results.
Administration’s Emergency Use Authorization.
erroneous test result.
SUMMARY AND EXPLANATION • Avoid skin contact with buffer containing sodium azide which is a skin irritant.
• If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening
The novel coronavirus belongs to the β genus. COVID-19 is an acute respiratory infectious disease. criteria recommended by public health authorities, specimens should be collected with appropriate
People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main infection control precautions and sent to state or local health departments for testing.
source of infection; asymptomatic infected people can also be an infectious source. Based on the current • Humidity and temperature can adversely affect results.
epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main
manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia STORAGE AND STABILITY
and diarrhea are found in a few cases.
• Store the Assure COVID-19 IgG/IgM Rapid Test Device at 2~30℃when not in use.
PRINCIPLE • DO NOT FREEZE.
• Kit contents are stable until the expiration dates marked on their outer packaging and containers.
The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow immunochromatographic assay for • Perform testing immediately after specimen collection. Serum and plasma specimens may be stored at 5. Wait for the blue line change to red line,read results at 15 minutes.
the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. This test uses 2-8°C for up to 7 days. For long term storage, serum or plasma specimens should be kept below -20°C. Note: Do not read results earlier than 15 minutes or after 30 minutes
anti-human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-mouse IgG Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days Specimens can also be applied using a micropipette.
(control line C) immobilized on a nitrocellulose strip. The conjugate pad contains recombinant after collection. Do not freeze whole blood specimens.
SARS-CoV-2 antigen (antigen is recombinant Nucleocapsid Protein and Spike Protein (S1)) conjugated • Containers containing anticoagulants such as sodium EDTA, should be used for whole blood storage. RESULT INTERPRETATION
with colloid gold. • Bring specimens to room temperature prior to testing. Frozen serum or plasma specimens must be
During testing, the specimen binds with SARS-CoV-2 antigen- conjugated gold colloid coated particles completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens. For Assure COVID-19 IgG/IgMTest:
in the test cassette. When a specimen followed by assay buffer is added to the sample well, IgM &/or • If specimens are to be shipped, pack them in compliance with all applicable regulations for
IgG antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This transportation of etiological agents. IgM and IgG Positive:*The colored line in the control region (C)
complex migrates through nitrocellulose membrane by capillary action. When the complex meets the changesfrom blue to red, and two colored lines should appear in IgG and
line of the corresponding immobilized antibody (anti-human IgM &/or anti-human IgG) the complex is TESTPROCEDURE IgM test regions. The color intensities of the lines do not have to match.
trapped forming a red line which confirm a reactive test result. Absence of a red line in the test region The result is positive for IgM and IgG antibodies.
indicates a non-reactive test result. Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to
To serve as a procedural control, a red line will always appear in the control line region, indicating that testing.
the proper volume of specimen has been added and membrane wicking has occurred. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch IgG Positive:*The colored line in the control region (C) changes from
The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or and use it as soon as possible. blue to red, and a colored line appears in the IgG test region. The result
IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves 2. Place the test device on a clean and level surface. Note:There should be a blue line in the control is positive for COVID-19virus specific-IgG antibodies.
as a procedural control, indicating that membrane wicking is working. region (next to “C”), discard the device if there is no blue line.
3. Label the test with patient or control identification.
REAGENTS AND MATERIALS 4. Add the specimens. IgM Positive:*The colored line in the control region (C) changesfrom
blue to red, and a colored line appears in the IgM test region. The result
Materials Provided For Venous Whole Blood Specimens, Serum or Plasma Specimens is positive for COVID-19 virus specific-IgM antibodies.
• Individually packed test devices • Buffer a) Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen
• Disposable pipettes • Package insert

Number:1110032033 REV1.4 Effective date: 2020-09-22 Page 1/3

 reinfection. Table 2. IgG/IgM NPA for the Assure COVID-19 IgG/IgM Rapid Test Device
Negative: The colored line in the control region (C) changes from blue 15. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the
to red. No line appears in IgM or IgG test regions. specimen is below the detection limits of the assay, or the antibodies that are detected are not IgG (Assure Device) IgM (Assure Device)
# PCR
present during the stage of disease in which a sample is collected. Site Antibody Antibody
Negative NPA 95%CI NPA 95%CI
16. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus Negative Negative
strains, such as coronavirus HKU1, NL63, OC43, or 229E. (Site 1+3+4)
96 96 100% 96.2%-100% 94 97.9% 92.7%-99.4%
17. Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection Serum
or to inform infection status. (Site 2)
9 9 100% 70.1%-100% 9 100% 70.1%-100%
18. Not for the screening of donated blood. Venous Whole Blood
Invalid: Control line (C) is still completely or partially blue, and fails to Combined Sites (Serum
completely change from blue to red. Insufficient buffer volume or 105 105 100% 96.5%-100% 103 98.1% 93.3%-99.5%
The sensitivity of the test is impacted after being open for one hour-the intensity of the T line becomes + Blood)
incorrect procedural techniques are the most likely reasons for control weak. Testing must be performed within one hour after opening the pouch.
line failure. Review the procedure and repeat the procedure with a new
test device. If the problem persists, discontinue using the test kit Conditions of Authorization for the Laboratory The NPA/specificity of the Assure COVID-19 IgG/IgM Rapid Test Device for IgG/IgM is 99.04%.
immediately and contact your local distributor.
The Assure COVID-19 IgG/IgM Rapid Test Device Letter of Authorization, along with the authorized Study II: Independent Clinical Agreement Validation
Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and other authorized The COVID-19 IgG/IgM Rapid Test Device from Assure Tech. (Hangzhou) Co., Ltd. was tested on
labeling are available on the FDA website: 2020-06-15 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations National Cancer Institute (NCI). The test was validated against a panel of previously frozen samples
NOTE: -medical-devices/vitro-diagnostics-euas. consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and
1. The color intensity in the test region may vary depending on the concentration of analytes Authorized laboratories using the Assure COVID-19 IgG/IgM Rapid Test Device (“your product” in the plasma samples. Each of the 30 antibody-positive samples was confirmed with a nucleic acid
present in the specimen. Therefore, any shade of color in the test region should be considered conditions below), must adhere to the Conditions of Authorization indicated in the Letter of amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30
positive. Note that this is a qualitative test only, and cannot determine the concentration of Authorization as listed below: samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior
analytes in the specimen. 1. Authorized laboratories* using your product will include the test result reports, all authorized Fact to testing with the Assure COVID-19 IgG/IgM Rapid Test Device. The presence of IgM and IgG
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples
reasons for control band failure. may be used, which may include mass media. were selected at different antibody titers.
2. Authorized laboratories using your product will use your product as outlined in the Instructions for All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples
QUALITY CONTROL Use. Deviations from the authorized procedures, including theauthorized clinical specimen types, selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked
authorized control materials, authorized other ancillary reagents and authorized materialsrequired to use serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the Assure
Internal Procedural Controls your product are not permitted. COVID-19 IgG/IgM Rapid Test Device. Confidence intervals for sensitivity and specificity were
The Assure COVID-19 IgG/IgM Rapid Test Device has built-in (procedural) controls.Each test device 3. Authorized laboratories that receive your product will notify the relevant public health authorities of calculated per a score method described in CLSI EP12-A2 (2008).
has an internal standard zone to ensure proper sample flow. The user should confirm that the blue band their intent to run your product prior to initiating testing. For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate
should be always located at the “C” region before testing, and the red band should be always present 4. Authorized laboratories using your product will have a process in place for reporting test results to among antibody-negative samples with HIV was statistically higher than the false positive rate among
before result interpretation. healthcare providers and relevant public health authorities, as appropriate. antibody-negative samples without HIV (for this, a confidence interval for the difference in false
External Positive and Negative Controls 5. Authorized laboratories will collect information on the performance of your product and report to positive rates was calculated per a score method described by Altman). The results and data analysis are
Good laboratory practice suggests testing positive and negative external controls to ensure that the test DMD/OHT7-OIR/OPEQ/CDRH（via email: CDRH-EUA-Reporting@fda.hhs.gov）and Assure Tech shown in the Tables 3 and 4 below.
reagents are working and that the test is correctly performed. (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. Summary Results
LIMITATIONS OF THE TEST your product of which they become aware. Assure COVID-19 Comparator Method
For use under an Emergency Use Authorization Only 6. All laboratory personnel using your product must be appropriately trained in immunoassay techniques
and use appropriate laboratory and personal protective equipment when handling this kit and use your
IgG/IgM Rapid Test
Device
Positive
(IgM/IgG) +
Negative
(IgM/IgG) -
Negative,
HIV+
Total
1. Use of the Assure COVID-19 IgG/IgM Rapid Test Device is limited to laboratory personnel who product in accordance with the authorized labeling. All laboratory personnel using the assay must also Positive IgM+/IgG+ 27 0 0 27
have been trained. Not for home use. be trained in and be familiar with the interpretation of results of the product. IgM+, IgG- 3 1 0 4
2. The Assure COVID-19 IgG/IgM Rapid Test Device is for in vitro diagnostic use only. The test 7. Assure Tech. (Hangzhou Co., Ltd), authorized distributors, and authorized laboratories using your
should be used for the detection of SARS-CoV-2 antibodies in venous whole blood, fingerstick IgM-, IgG+ 0 0 0 0
product will ensure that any records associated with this EUA are maintained until otherwise notified by Negative IgM-/IgG- 0 69 10 79
whole blood, serum or plasma specimens only. Neither quantitative value nor the rate of increase FDA. Such records will be made available to FDA for inspection upon request.
in SARS-CoV-2 antibody concentration can be determined by this qualitative test. Total (n=110) 30 70 10 110
*Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical
3. The Assay Procedure and the Interpretation of Assay Result must be followed closely when Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to
testing for the presence of SARS-CoV-2 virus specific antibodies in the serum, plasma or whole perform moderate or high complexity tests.
blood specimen from individual subjects. For optimal test performance, proper sample collection Table 4. Summary Statistics
is critical. Failure to follow the procedure may give inaccurate results. This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care Measure Estimate Confidence Interval
4. Reading test results earlier than 15 minutes after the addition of Buffer may yield erroneous (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of
results. Do not interpret the results after 30 minutes. IgM+ Sensitivity (PPA) (30/30) 100% (88.7%; 100%)
Compliance, or Certificate of Accreditation.
5. Adding more or less than 1 drop of specimen may lead to erroneous results. IgM- Specificity (NPA) (79/80) 98.8% (93.3%; 98.8%)
6. Adding 1 drop of buffer or more than 4 drops of buffer may lead to erroneous results. PERFORMANCE CHARACTERISTICS IgG+ Sensitivity (PPA) (27/30) 90.0% (74.4%; 96.5%)
7. The Assure COVID-19 IgG/IgM Rapid Test Device will only indicate the presence of IgG- Specificity (NPA) (80/80)100% (95.4%; 100%)
SARS-CoV-2 antibodies in the specimen and should not be used for the diagnosis of acute Clinical Evaluation Combined Sensitivity (30/30) 100% (88.7%; 100%)
SARS-CoV-2. A molecular assay should be used to evaluate symptomatic patients for acute Combined Specificity (79/80) 98.8% (93.3%; 98.8%)
COVID-19. Combined PPV for prevalence = 5% 80.8% (40.9%; 96%)
Study I
8. In the early onset of symptom, anti-SARS-Cov-2 IgM and IgG antibody concentrations may be Combined NPV for prevalence =
below detectable levels. Total of 61 positive and 105 negative serum or venous whole blood samples were collected at 4 different 100% (99.4%; 100%)
study sites. These samples were tested with both RT-PCR method for SARS-CoV-2 infection and 5%
9. SARS-CoV-2 IgG antibodies may be below detectable levels in patients who have been exhibiting
symptoms for less than 15 days. Assure COVID-19 IgG/IgM Rapid Test device for antibodies. The obtained PPA/sensitivity and (0/10) 0%
NPA/specificity results are summarized in following tables. Cross-reactivity with HIV+ -----------------
10. A high dose “hook effect” may occur where the color intensity of test band decreases as the not detected
concentration of anti-SARS-CoV-2 IgG/IgM increases. If a “hook effect” is suspected, dilution Table 1. IgG/IgM PPAfor the Assure COVID-19 IgG/IgM Rapid Test Device
of specimens may increase color intensity of the test band. Study III
IgG (Assure Device) IgM (Assure Device)
11. Results from immunosuppressed patients should be interpreted with caution. Days from # PCR
Total of 42 positive and 113 negative fingerstick whole blood samples were collected and tested at 3
Site Antibody Antibody
12. As with all diagnostic tests, all results must be interpreted together with other clinical symptom Positive PPA 95%CI PPA 95%CI different POC sites. These samples were tested with both RT-PCR method for SARS-CoV-2 infection
Positive Positive
information available to the physician. and Assure COVID-19 IgG/IgM Rapid Test device for antibodies. The PPA/sensitivity and
0-7 days 8 7 87.5% 52.9%-97.8% 8 100% 67.6%-100%
13. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis (Site 1+3+4) NPA/specificity results are summarized in following tables.
for patient management decisions. Antibodies may not be detected in the first few days of 8-14 days 15 13 86.7% 62.1%-96.3% 13 86.7% 62.1%-96.3%
Serum
infection; the sensitivity of the Assure COVID-19 IgG/IgM Rapid Test Device early after ≥15 days 25 25 100% 86.7%-100% 21 84% 65.3%-93.6%
infection is unknown. False positive results for IgM and IgG antibodies may occur due to (Site 2) 0-7 days 1 1 100% 20.7%-100% 1 100% 20.7%-100%
Venous 8-14 days 3 3 100% 43.9%-100% 3 100% 43.9%-100%
Table 5. IgG/IgM PPA for the Assure COVID-19 IgG/IgM Rapid Test Device
cross-reactivity from pre-existing antibodies or other possible causes. Consider other information
including clinical history and local disease prevalence, in assessing the need for a second but Whole Blood ≥15 days 9 9 100% 70.1%-100% 9 100% 70.1%-100% IgG (Assure Device) IgM (Assure Device)
Days from # PCR
different serology test to confirm an immune response. Site Antibody Antibody
symptom Positive PPA 95%CI PPA 95%CI
14. It is unknown at this time if the presence of antibodies to SARS-CoV-2 confers immunity to Positive Positive

Number:1110032033 REV1.4 Effective date: 2020-09-22 Page 2/3

 0-7 days 2 0 0% 0%-57.5% 2 100% 42.5%-100% Table 7. Cross-reactivity Study Data of Assure COVID-19 IgG/IgM Rapid Test Device Coffee (caffeine) 308 µmol/L
(Site 1+2+3) 8-14 days 12 10 83.3% 55.2%-95.3% 10 83.3% 55.2%-95.3% Number of Number of
Conditions Conditions Alcohol (ethanol) 86.8 mmol/L
≥15 days 28 28 100% 91.2%-100% 25 89.3% 72.8%-96.3% samples samples
Anti-HAV IgM + 5 Lyme disease+ 5 LITERATURE REFERENCES
Anti-HEV IgG + 2 P. falciparum + 5
Site 1 IgG IgM IgG/IgM 1. 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).
Days from # PCR Antibody PPA 95% CI Antibody PPA 95% CI Antibody PPA 95% CI Anti-HCV + 5 Toxoplasma IgM + 5 2. Ithete, N. L. et al. Close relative of human Middle East respiratory syndrome coronavirus in bat,
Anti-HIV + 5 HAMA + 1 South Africa. Emerg. Infect. Dis. 19, 1697–1699 (2013).
symptom positive positive positive positive
Anti-Rubella IgM + 5 RF + 5 GLOSSARY OF SYMBOLS
0-7 days 0 0 NA NA 0 NA NA 0 NA NA
Anti-CMV IgM + 5 ANA+ 5
8-14 days 0 0 NA NA 0 NA NA 0 NA NA Anti-HSV-I IgM + 5 Anti-Influenza A IgM + 3 Catalog number Temperature limitation
Anti-HSV-II IgM + 5 Anti-Influenza B IgM + 1 Consult instructions for use Batch code
≥15 days 11 11 100% 80.3%-100% 10 90.9% 62.3%-98.4% 11 100% 80.3%-100%

EBV IgM + 4 Anti-RSV IgM + 3 In vitro diagnostic medical device Use by

Site 2 IgG IgM IgG/IgM
Anti-Dengue IgM + 5 Legionella pneumophila IgM+ 2 Manufacturer Do not reuse
Days from # PCR Antibody PPA 95% CI Antibody PPA 95% CI Antibody PPA 95% CI Anti-Yellow fever + 5 Anti-Adenovirus IgM + 1
Manufactured by:
symptom positive positive positive positive 5 Anti-Mycoplasma pneumonia 3 Assure Tech. (Hangzhou) Co., Ltd.
Anti-Zika IgG + Building 4, No. 1418-50, Moganshan Road,
IgM +
0-7 days 2 0 0% 0%-57.5% 2 100% 42.5%-100% 2 100% 42.5%-100% Gongshu District, Hangzhou, 310011 Zhejiang, China
5 Anti-Chlamydia pneumonia 3 contact@diareagent.com
Chagas Ab+
8-14 days 7 6 85.7% 48.7%-97.4% 7 100% 72.1%-100% 7 100% 72.1%-100% IgM +
US Representative:
≥15 days 9 9 100% 76.9%-100% 9 100% 76.9%-100% 9 100% 76.9%-100%
4 Anti-Chlamydia pneumonia 2 Azure Biotech Inc.
Anti-Syphilis IgG +
IgG + 5250 Gulfton Street, Ste 2C
Site 3 IgG IgM IgG/IgM Houston, TX 77081, United States
Anti-Tuberculosis + 5 Measles IgG + 1
cs@azure.bio
Days from # PCR Antibody PPA 95% CI Antibody PPA 95% CI Antibody PPA 95% CI Typhoid IgM + 5 Mumps IgG + 1 www.azure.bio
Customer Service Phone: 1-800-618-5829
symptom positive positive positive positive Service date/hours: Monday through Friday 9:00 AM to 5:00 PM CST
0-7 days 0 0 NA NA 0 NA NA 0 NA NA
Interfering Substances
The assay performance of COVID-19 IgG/IgM Rapid Test Device is not affected by substances at
8-14 days 5 4 80% 37.6%-96.4% 3 60% 23.1%-88.2% 5 100% 64.9%-100% concentrations listed below.

≥15 days 8 8 100% 74.7%-100% 6 75% 40.9%-92.9% 8 100% 74.7%-100% Table 8. Interference Study Data of Assure COVID-19 IgG/IgM Rapid Test Device
Interfering substances Concentration of analyate
Blood analytes
Table 6. IgG/IgM NPA for the Assure COVID-19 IgG/IgM Rapid Test Device Albumin 5 g/dL
IgG (Assure Device) IgM (Assure Device) Anticoagulants
# PCR
(Site 1+2+3) Antibody Antibody EDTA (sodium salt) 3.4 µmol/L
Negative NPA 95%CI NPA 95%CI
Negative Negative
Combined Sites 113 113 100% 97.7% -100% 113 100% 97.7%-100%
Heparin 3000 U/L
Sodium citrate 5 mg/mL
Site 1 IgG IgM IgG/IgM Potassium oxalate 2 mg/mL
Abnormal blood sample
# PCR Antibody NPA 95% CI Antibody NPA 95% CI Antibody NPA 95% CI
Visual hemolysis (Hemoglobin) 20 g/dL
negative negative negative negative Icteric (Bilirubin) 5 mg/dL
20 20 100% 88.1%-100% 20 100% 88.1%-100% 20 100% 88.1%-100%
Lipemic (Triglycerides) 500 mg/dL
Common medicines
Site 2 IgG IgM IgG/IgM
Acetylsalicylic acid 3.62 mmol/L
# PCR Antibody NPA 95% CI Antibody NPA 95% CI Antibody NPA 95% CI Ascorbic acid (Vitamin C) 342 µmol/L
Amoxicillin 206 µmol/L
negative negative negative negative
Fluconazole 245 µmol/L
53 53 100% 95.1%-100% 53 100% 95.1%-100% 53 100% 95.1%-100%
Ibuprofen 2425 µmol/L
Site 3 IgG IgM IgG/IgM Loratadine 0.78 µmol/L
Nadolol 3.88 µmol/L
# PCR Antibody NPA 95% CI Antibody NPA 95% CI Antibody NPA 95% CI
Naproxen 2170 µmol/L
negative negative negative negative Paroxetine 3.04 µmol/L
40 40 100% 93.7%-100% 40 100% 93.7%-100% 40 100% 93.7%-100% Anti-malarial medicines
Quinine 148 µmol/L
The NPA/specificity of the Assure COVID-19 IgG/IgM Rapid Test Device for IgG/IgM in fingerstick Anti-tuberculosis medicines
whole blood samples is 100%. Rifampicin 78.1 µmol/L
Isoniazid 292 µmol/L
Cross Reactivity
There was no cross-reactivity with plasma specimens meeting the disease state shown below. No IgM or Ethambutol 58.7 µmol/L
IgG false positive results were observed with the following potential cross-reactants: Common consumables

Number:1110032033 REV1.4 Effective date: 2020-09-22 Page 3/3

 Quick Reference Instructions of
Assure COVID-19 IgG/IgM Rapid Test Device
1 This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. It is a point of care test for
fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
2 This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for
the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19
under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
3 Read the complete Quick Reference Instructions before performing the test. For technical assistances, please call (800) 618-5829.
4 There should be a blue line in the control region (next to “C”) before testing, discard the device if there is no blue line.
5 Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

1 Before you begin 2 3 4

-Refer to the package insert Fill line
for more information
-Read through the entire
Quick Reference Instructions
before beginning a test
-Bring test components show
below to room temperature
before starting
1.Remove the test 2.Clean the puncture site 3.Remove the cap. Push 4.Draw the specimen
cassette from the with the alcohol prep pad the safety lancet firmly above the fill line.
sealed pouch and use it provided. against the puncture site.
as soon as possible.
5 1 drop of
6 7
2 drops of buffer C C C
whole blood IgG IgG IgG
IgM IgM IgM

IgG＆IgM IgG IgM

Positive Positive Positive

15 minutes
C C C
IgG IgG IgG
5.Transfer 1 drop of 6. Add 2 drops of buffer and start 7. Read result at 15
specimen into the specimen the timer. Adding 1 drop of buffer or minutes after adding
IgM IgM IgM

well. Adding more or less more than 4 drops of buffer may buffer, do not interpret the
than 1 drop of specimen may lead to erroneous results. Wait for Negative Invalid Invalid
result after 30 minutes.
lead to erroneous results. the blue line change to red line.

Quick Reference Instructions of COVID-19 IgG/IgM Control

For Positive control

Negative
Control
30μl
purified
water
Positive Negative Positive
Control Negative Negative control control Positive
control well control well well well control well

1. Remove the control 2. Open the 3. Add 30μl purified 4. Draw the liquid 5. Transfer all the mixed 6. Draw the liquid up
well from the sealed positive control water into the up and down for liquid of negative control and down for 5-10 times
pouch and use it as and one of the negative control well 5-10 times to into the positive control to vigorously mix and
soon as possible. negative control. by micropipette. vigorously mix. well. wait to be used.

For Negative control

30μl
Negative purified
Control water

Negative Negative
control well control well

1. Remove the negative 2. Open one of 3. Add 30μl purified water 4. Draw the liquid up and down Remove the test cassette
control well from the the negative into the negative control for 5-10 times to vigorously from the sealed pouch and
sealed pouch and use it control. well by micropipette. mix and wait to be used. use it as soon as possible.
as soonas possible.

2 drops of buffer 1 drop of

C
control solution
IgG
Fill line Negative or
IgM positive control
solution
For positive control
15 minutes
C
IgG Read result at 15 minutes Add 2 drops of buffer Transfer 1 drop of Draw the positive
IgM after adding buffer, do not and start the timer. positive or negative or negative control
For negative control interpret the result after Wait for the blue line control solution into solution above the
30 minutes. change to red line. the specimen well. fill line.

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