13485:2016 Certiﬁcation TESTING KITSushealthdefense.com/USHD_MT_test.pdf · BB Rapid-MT Test Kit *Manufacturer has the ISO 13485:2016 Certiﬁcation. EST LOWER UPPER Sensitivity

COVID-19 TESTING KITS

25440 Pleasant Valley Rd. Chantilly, VA [email protected] | www.ushealthdefense.comUS HEALTH DEFENSE

US HEALTH DEFENSE

BB Rapid-MT Test Kit

* Manufactured in the USA* Manufacturer has ISO 13485:2016 Certification

BB Rapid-MT Test Kit

Packaging:

*Manufacturer has the ISO 13485:2016 Certification.

Box Contents & Cost:


Control line

Test line

CT

CT

Positive

CT

Negative

CT

Suspect

CT

CT

Invalid

Product Description:This kit is suitable for the qualitative detection of novel coronavirus (SARS-CoV-2) IgM & IgG antibodies in human serum, and whole blood. The detection kit uses the principle of immunochromatography: the separation of components in a mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen.

Result Interpretation:• Negative: If only the control line (C) appears and the test line (T) is not visible, then no novel

coronavirus antibody has been detected.• Positive: If both the control line (C) and the detection line (T) appear, then the novel coronavirus

antibodies have been detected and the result is positive.• Suspect: A light pink band is an inconclusive result. The sample requires an alternate testing method

(such as RT-qPCR) to determine that the result is positive. • Invalid: No visible colored bands appear at control line after performing the test. The directions may

not have been followed correctly or the test may have deteriorated. It is recommended to re-testthe specimen.

Auxiliary test for the diagnosis of corona virus infection disease (COVID-19)Easy to use, instant result in 10 minutes.

• 20 IgG/IgM pouches each containing: • 1 combined test cassette • 1 disposable pipette • 1 desiccant pouch• 20 dilution buffer tubes• 20 disposable lancets• 20 bandages• Instructions for use

* Manufactured in the USA

Cost per Box Cost per Kit Kits per Box $600 $30 20

BB Rapid-MT Test Kit*Manufacturer has the ISO 13485:2016 Certification.

EST LOWER UPPERSensitivity 85.42 72.24 93.93

Specificity 98.48 91.84 99.96

Diagnostic Accuracy 92.98 86.64 96.92

Accuracy: In Population with RT-PCR/Clinical Diagnosis Results

PCR Nucleic Tests Igm/IgG Rapid TestTurnaround Time > 1 Hour < 10 Minutes

Facility Requirement PCR Laboratory No special facilities needed

Operation Requires trained technicians Whole blood, serum, or plasma

Requires expensive equipment Test can be used anywhere

Complicated operation No specialized training required

Prone to False Negatives Results are clear and easy to read

Transport/Storage Requires cold-chain Room Temperature

Clinical Value Commonly used, gold standard Highly specific

Comparison With PCR Nucleic Acid Tests & IgM IgG Dual Rapid Test

Kappa: 0.845


Product Summary:

It is well established that the initial defense to a foreign antigen involves a complex immune response, both innate and adaptive types. Antibody response in the form of IgM provides a critical defense during early stages of viralinfections. Subsequent development of a longer-term IgG antibody further augments the adaptive immune response and may eventually lead to some form of immunological memory. Testing of COVID-19 IgM and IgG antibodies, therefore is an effective method for early detection of humoral response to COVID-19infection and of diagnostic value. Whereas viral presence may wane subsequently, antibody response will be rising, especially from the second week onwards, allowing for greater assessment of SARS-CoV-2 infection andexposure. As such, serological antibody testing can be of significant point-of-care COVID-19 assessment method.



BB Rapid-MT Test KitNovel Coronavirus (SARS-CoV-2) Combined IgG/IgM Antibody Detection Kit (Colloidal Gold)


Disclaimers:* This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.* This kit is designed to detect antibodies against SARS-CoV-2 in human whole blood, serum sample.* This test has not been reviewed by the FDA.* Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnosticshould be considered to rule out infection in these individuals.* Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.* Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.* Not for the screening of donated blood.* This product is for in vitro diagnostic use only. It follows guidance from the FDA for Emergency Use Authorizations of tests submitted on March 16, 2020.

C

CM

G

T

T

S

S

1

Clean the collection area with an alcohol swab and puncture fingertip using a lancet. Whole blood samples may also be used.

2

Using the provided pipette, fill the pipette tip with blood.

3

Transfer blood from the pipette to dilution buffer tube.

Diluent

Diluent

4

Mix diluted sample thoroughly.

5

Add 2-3 drops of the diluted sample to each release pad section (S) of the combined test cassette.

6

Wait 8-10 minutes.

7Control Line

Test Line

Antibodies Not Detected

*Refer to the instruction manual for further details.

CC

M G

TT

SS

CC

M G

TT

SS

Antibodies Detected


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BB Rapid-MX Test Kit

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Documents

13485:2016 Certiﬁcation TESTING KITSushealthdefense.com/USHD_MT_test.pdf · BB Rapid-MT Test Kit *Manufacturer has the ISO 13485:2016 Certiﬁcation. EST LOWER UPPER Sensitivity