A rapid test for the qualitative detection of IgG and IgM antibodies against 2019-nCoV in human whole blood, serum or plasma samples. For professional in vitro diagnostic use only.

Expected Use

The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies against 2019-nCoV in human blood, serum or plasma samples.


In early January 2020, a new coronavirus (2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019. Coronaviruses are enveloped RNA viruses that are widely distributed among humans, other mammals, and birds and cause respiratory, enteric, liver, and neurological diseases. Six species of coronavirus are known to cause disease in humans. Four viruses: 229E, OC43, NL63, and HKU1, are prevalent and generally cause common cold symptoms in immunocompetent people.

The other two strains, severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV ), are zoonotic in origin and have been linked to sometimes fatal diseases. Coronaviruses are zoonotic, which means they are transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath, and shortness of breath.

In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. Standard recommendations to prevent the spread of infection include regular hand washing, covering your mouth and nose when coughing and sneezing, cooking meat and eggs thoroughly. Avoid close contact with anyone showing symptoms of respiratory illness, such as coughing and sneezing.


The 2019-nCoV IgG/IgM All Test Cassette (Whole Blood/Serum/Plasma) is a qualitative test Membrane-based immunoassay for the detection of IgG and IgM antibodies against 2019-nCoV in whole blood, serum, or plasma samples. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated on the IgG test line region. During testing, the sample reacts with 2019-nCoV antigen-coated particles in the test cassette.

The mixture then migrates chromatographically up the membrane by capillary action and reacts with anti-human IgG in the IgG test line region, if the sample contains IgG antibodies to 2019-nCoV. As a result, a coloured line will appear in the IgG test line region. Similarly, anti-human IgM is coated on the IgM test line region and, if the sample contains IgM antibodies to 2019-nCoV, the conjugate-sample complex reacts with anti-human IgM. As a result, a coloured line appears in the IgM test line region.

Therefore, if the sample contains 2019-nCoV IgG antibodies, a coloured line will appear in the IgG test line region. If the sample contains 2019-nCoV IgM antibodies, a coloured line will appear in the IgM test line region. If the sample does not contain 2019-nCoV antibodies, no coloured line will appear in any of the test line regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of sample has been added and membrane absorption has occurred.


The test contains anti-human IgM and anti-human IgG as a capture reagent, 2019-nCoV antigen as a detection reagent. A goat anti-mouse IgG is used in the control line system.


Saliva Test

Saliva Tests

Saliva testing is a noninvasive collection method in which patients collect their saliva in plastic tubes to measure hormones such as cortisol, estrogens, progesterone, and androgens. This non-invasive saliva collection is ideal for patients because it allows them to collect their samples in the privacy of their homes or office.

Why do we analyze hormones in saliva?

Steroid hormones in the bloodstream are 95-99% bound to carrier proteins and thus are unavailable to target tissues. Saliva tests measure the amount of hormone available to target tissues – the bioavailable amount. For this reason, the saliva test is best related to specific symptoms of excess or deficiency and is a good option for monitoring hormone therapy.

Some analytes cannot be tested using immunoassays, the methodology used for most of our saliva tests. For that reason, ZRT developed an LCMS saliva steroid profile using liquid chromatography/tandem mass spectrometry (LC-MS/MS). This profile analyzes a wide range of bioavailable hormones and hormone metabolites in one convenient collection of saliva samples.

The LCMS test allows accurate reporting of estrogens down to extremely low levels, such as those seen in men, children, and people using aromatase inhibitors, and includes a test for ethinylestradiol, 3-hormone blockers, and melatonin.  ZRT is one of the first laboratories to measure hormones in saliva and helped establish the method that made salivary hormone testing commercially viable for healthcare providers and patients around the world.

The most advanced saliva tests today

  • Supplementation adjusted ranges:

Unlike other labs, patients do not need to stop hormone supplementation to use ZRT tests because we have ranges adjusted for age, menstrual status, and types of supplementation. This is the ideal method for tracking the effectiveness of hormone treatments.

  • No grouping:

ZRT does not pool patient samples, which means we do not pool multiple daily samples to get an average hormone level. Instead, we measured hormones from a single morning sample, which represents the peak of daily hormone production, the optimal time to measure.

  • Extraction:

ZRT is the only laboratory that performs an extraction process for saliva testing, which separates hormones from background contamination. This is the only way to ensure accurate test results for low concentration hormones like estradiol.

  • Establishment of industry standards:

ZRT initiated and manages the industry-wide standards program called the Interlaboratory Saliva Proficiency Testing Program, which enables laboratories to evaluate and improve the accuracy of saliva tests on a regular basis.


Combo Tests

Expected Use

The Rapid COVID-19 IgM/IgG Combo Test Kit is a lateral flow immunoassay intended for qualitative detection and differentiation of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against SARS-CoV-2 in human serum, acid citrate dextrose (ACD) plasma, and fingerstick whole blood. The fast COVID-19. The IgM/IgG Combination Test Kit is designed to help identify individuals with an adaptive immune system response to SARS-CoV-2, indicating recent or previous infection.

The COVID-19 IgM/IgG Rapid Combination Test Kit should not be used to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown how prolonged antibodies persist after infection and whether the presence of antibodies confers protective immunity. Serum and plasma testing are limited to laboratories certified under the Clinical Laboratory Improvement Program. Amendments of 1988 (CLIA), 42 U.S.C 263a, which meet the requirements for conducting moderate or high operations complexity tests.

Fingerstick testing of whole blood samples is limited to laboratories certified by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, who meet the requirements to hold a stop, Tests of moderate or waived complexity. The Fingerstick Whole Blood Sample Test is licensed for use in the Point of Care (POC), that is, inpatient care settings operating under a CLIA Certificate of Exemption, Certified of Compliance, or Certificate of Accreditation.

The results are for the detection of IgM and IgG SARS CoV-2 antibodies. IgM and IgG antibodies against SARS-CoV-2 are usually detectable in the blood several days after the initial infection, although the length of time the antibodies are present after infection is not well characterized. People may have a detectable virus present for several weeks after seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Rapid COVID-19 IgM/IgG Combination Test Kit after early infection is unknown. Negative results do not rule out an acute SARS-CoV-2 infection. If the acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False-positive results for the Rapid COVID-19 IgM/IgG Combination Test Kit may occur due to cross reactivity of pre-existing antibodies or other possible causes. Due to the risk of false-positive results, confirmation of positive results should be considered using a second, different IgG or IgM assay. The Rapid COVID-19 IgM/IgG Combination Test Kit is for use under the Food and Drug Administration Emergency Use Authorization.


COVID-19 is an acute infectious disease caused by the SARS-CoV-2 virus. The incubation period of the illness varies from 1 to 14 days, during which time infected people can infect other people. Acute SARSCoV 2 infection can also present without symptoms. Respiratory droplets and contact are the main routes of transmission Initial symptoms of patients include fever, fatigue, and cough, which may develop in dyspnea and other severe manifestations. Some of the severe cases may have acute respiratory distress septic syndrome or shock, or even death.

There is several days of incubation period after infection with the SARS-CoV-2 virus. IgM antibodies can be detected shortly after the incubation period and remain for a short time. IgG antibodies may appear after a few days of incubation period and remain in circulation in the blood for several weeks. A positive IgG result can be an indicator of a recent or previous infection.


Rapid COVID-19 IgM/IgG Combo Test Kit uses the principle of immunochromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgM line in the test window is closest to the sample well followed by the IgG line. As the test sample flows through the membrane inside the test device, the colloidal gold-recombinant antigen conjugate of the coloured COVID 19 virus is formed complexes with specific antibodies (IgM and/or IgG) against the COVID-19 virus, if present in the sample.

The antigen targets a segment of the SARS-CoV-2 nucleocapsid (N) protein. This complex progresses further the membrane to the test region where it is captured by anti-human IgM and/or human IgG antibodies coated on the membrane leading to the formation of a coloured band, indicating positive test results. The absence of this colour band in the test window indicates a negative test result. A built-in control line always appears in the test window when the test is successful, regardless of the presence or absence of antibodies against the new coronavirus 2019 in the sample.

Supplied Materials

  • COVID-19 IgM/IgG Rapid Combination Test Kit
  • Individual sample buffer
  • 2 μL capillary pipette (serum and plasma only)
  • 5 μL capillary pipette (finger prick only)
  • Sterile safety lancet
  • Insert package

Materials Required But Not Provided

  • Clock or stopwatch, sample collection container, biohazard waste container, disposable gloves, disinfectant.
  • External controls are not included with the kit but are commercially available from Megna Health under catalogue number: RAK-CON-001.


1. Store the test device at a temperature of 4 to 30o C in the original sealed bag. Do not freeze.
2. The expiration date indicated on the bag was established under these storage conditions.
3. The test device must remain in its original sealed bag until ready for use. After opening, the test device must be used immediately. Do not reuse the device.

Warnings And Precautions

  • For use only under an Emergency Use Authorization. For in vitro diagnostic use only
  • This test has not been licensed or approved by the FDA but has been authorized for emergency use by the FDA under a EUA for use by authorized laboratories.
  • The Fingerstick Whole Blood Sample Test is authorized for use at the point of care (POC), that is, inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or  Certificate of Accreditation.
  • This test has been authorized only to detect the presence of IgM and IgG antibodies against SARS-CoV2, not against other viruses or pathogens.
  • The emergency use of this test is only authorized for the duration of the declaration that the circumstances exist that justify the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1) unless the declaration is terminated or the authorization is revoked earlier.
  • Do not use the product beyond the expiration date.
  • Do not use the product if the bag is damaged or the seal is broken.
  • Handle all specimens as potentially infectious.
  • Follow standard laboratory procedures and biosafety guidelines for handling and disposal of infectious material. When the test procedure is finished, discard the samples based on the relevant status and federal requirements for biological samples.
  • Tests are for single use only.

Preparation For Sample Collection

The serum, ACD plasma, or fingerstick whole blood specimen should be collected according to standard laboratory guidelines terms

1. Heat inactivation of samples, which can cause hemolysis and protein denaturation, should be avoided.
2. The test works best on fresh samples. If the test cannot be performed immediately, serum and plasma ACD can be stored at 2-8ºC for up to 3 days in case of delayed testing. For long-term storage, serum and ACD plasma samples can be frozen at -20ºC for 3 months or at -70ºC for a longer period. avoid repeating
freeze/thaw cycles.

Fingerstick samples must be collected with approved lancets and tested immediately.