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ManualsBrandsClarity Diagnostics ManualsCoronavirus TestsCOVIBLOCK Covid-19 IgG/IGM Antibody Test Cassettes - 20/bx

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Clarity COVIBLOCK™

COVID-19 lgG/lgM Rapid Test Cassette

(Whole Blood/ Plasma/Serum/Fingerstick

Whole Blood)

For in vitro diagnostics use only

For prescription use only

For Emergency Use Authorization only

The Clarity COVIBLOCK

COVID-19 IgG/IgM Rapid Test Cassette is

a membrane-based lateral flow immunoassay intended for the

qualitative detection and differentiation of IgG and IgM antibodies to

SARS-CoV-2 in human serum, plasma (dipotassium EDTA, sodium

citrate, sodium heparin), venous whole blood (dipotassium EDTA,

sodium citrate, sodium heparin) and fingerstick whole blood. The

Clarity COVIBLOCK

COVID-19 IgG/IgM Rapid Test Cassette is

intended for use as an aid in identifying individuals with an adaptive

immune response to SARS-CoV-2, indicating recent or prior infection.

The Clarity COVIBLOCK

COVID-19 IgG/IgM Rapid Test should not

be used to diagnose acute SARS-CoV-2 infection. At this time, it is

unknown for how long antibodies persist following infection and if the

presence of antibodies confers protective immunity.

Testing of serum, plasma and venous whole blood specimens is

limited to laboratories certified under the Clinical Laboratory

Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet

requirements to perform high or moderate complexity tests.

Testing of fingerstick whole blood specimens is limited to laboratories

certified under the Clinical Laboratory Improvement Amendments of

1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform

high, moderate or waived complexity tests. Testing of fingerstick whole

blood specimens is authorized for use at the Point of Care (POC), i.e.,

in patient care settings operating under a CLIA Certificate of Waiver,

Certificate of Compliance, or Certificate of Accreditation.

Results are for the detection of SARS-CoV-2 antibodies. IgG and IgM

antibodies to SARS-CoV-2 are generally detectable in blood several

days after initial infection, although the duration of time antibodies are

present post-infection is not well characterized. Individuals may have

detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to

report all results to the appropriate public health authorities.

The sensitivity of Clarity COVIBLOCK

COVID-19 IgG/IgM Rapid

Test Cassette early after infection is unknown. Negative results do not

preclude acute SARS-CoV-2 infection. If acute infection is suspected,

direct testing for SARS-CoV-2 is necessary.

False positive results for the Clarity COVIBLOCK

COVID-19 IgG/IgM

Rapid Test Cassette may occur due to cross reactivity from 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 SARS-CoV-2 IgG or IgM assay.

Samples should only be tested from individuals that are 15 days or

Summary of content (6 pages)

PAGE 1
region. During testing, the specimen reacts with SARS-CoV-2 antigencoated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgM in IgM test line region. Clarity COVIBLOCK™ COVID-19 lgG/lgM Rapid Test Cassette (Whole Blood/ Plasma/Serum/Fingerstick Whole Blood) If the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in IgG test line region.
PAGE 2
• This test has been authorized only for detecting the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. • Do not use after expiration date. • Do not use if the pouch is torn or open. • Do not eat, drink or smoke in the area where the specimens or kits are handled. • Handle all specimens as if they contain infectious agents.
PAGE 3
a new lot is used, when a new operator performs the test, or when the test is run in a new room/laboratory, etc. as a good laboratory practice to confirm the test procedure and to verify proper test performance. pipette provided with the test dispenses approximately 10 µl in one drop even if more blood is aspirated in the pipette. e. Add 2 drops of buffer (approximately 80μl) to the buffer well (B) and start the timer. Wait for the colored line(s) to appear. Read results at 10 minutes.
PAGE 4
1. Authorized laboratories* using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media 2. Authorized laboratories using your product must use your product as outlined in the Instructions for Use.
PAGE 5
Seroconversion study: Days post-PCR testing Days between date of Number IgM IgG of PCR comparator test and IgM Positive Positive IgG PPA PPA collection of Samples results results Tested plasma/serum sample 0-7 days 26 1 3.85% 1 3.85% 8-14 days 29 25 86.21% 18 62.07% ≥15 days 26 24 92.31% 23 88.
PAGE 6
2. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17:181-192. 3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502. 4. Microbiology Advisory Committee. “COVID19 IgG/IgM RAPID POCT TESTS”. The Royal College of Pathologists of Australasia, 1/2020 5. WHO. Coronavirus disease 2019 (COVID-19) Situation Reports. Available from: https://www.who.