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For In Vitro Diagnostic Use Only

Easy, Efficient & Accurate

Screening Device for COVID-19

• COVID-19 Positive/Negative Results in 15 Minutes

• Works with Fingerstick, Whole Blood, Serum MadeinIN
MADE the USA
USA
or Plasma
• Increased Screening with IgM and IgG
Antibody Detection

• Ideal High-Volume Screening Device to

Complement Nucleic Acid Tests

managingdirector@aquarose.ec
 Always Innovating
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Testing for Antibodies

The human immune system is an incredibly effective • The IgM antibody can be detected in
patient specimen 3-6 days after infection
defense mechanism in fighting and protecting the body
• Positive result indicate a
against disease. When a patient is infected by the SARS- presumptive infection
CoV-2 virus, the immune system will begin to form IgM
• Negative results are a presumptive
antibodies as the first line of defense. While IgM antibodies indication of no infection
are effective in the fight against infection, as the immune
system mounts a more direct defense against the infection
COVID-19 IgM/IgG
Antibody Test
Clinical Sensitivity 93.5%
Clinical Specificity 100%
Relative Accuracy 97.9%

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Finger Stick/Whole Blood Testing Procedure

1 2 3 4 COVID-19
IgM/IgG Test

Collect 20ul whole blood Place 2-3 drops of buffer Wait 15 minutes. Read results.
and add sample to the into the sample well.
sample well on the test.

Serum/ Plasma Testing Procedure

1 2 3 4 COVID-19
IgM/IgG Test

Collect 10ul of Add serum/plasma Place 2-3 drops of Read results after
serum/plasma. sample to sample well. buffer in sample well. 15 minutes.

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the body will begin to form specialized IgG

antibodies. IgG antibodies are highly specific to
the disease in question, they will appear in a later
stage of the infection and remain in the body for
Test Results Colloidal Gold Fluorescence-PCR
Test Time 15 minutes 3-4 hours
some time after the infection has been defeated.
Operation Method Simple without supporting Complex with supporting
equipment required equipment required
The COVID-19 IgM/IgG Antibody Test is designed
Portability Highly portable and stable test Requires highly complex
device at room temperature. equipment only available in to quickly detect and differentiate both the IgM
Testing can be conducted at large hospitals
point of care including certified
and IgG antibodies produced by the immune
small labs, clinics or patient system during a COVID-19 infection.

Results Interpretation
COVID-19 COVID-19 COVID-19 COVID-19
IgM/IgG Test IgM/IgG Test IgM/IgG Test IgM/IgG Test
NOTE: On this device any line,
no matter how faint, is considered
a line. Do NOT compare test line
intensity to control line.

NEGATIVE POSITIVE

Control Line
COVID-19 COVID-19 COVID-19 COVID-19
IgM/IgG Test IgM/IgG Test IgM/IgG Test IgM/IgG Test IgG Line

IgM Line

Sample Well

INVALID

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SARS-COV-2 Antigen and IgG/IgM Antibody Test Results & Clinic Significance

Test Results
Clinical Implications

+ – – Patients may be in the “window period” of SARS-COV-2 infection.

Patient may be in the early stage of infection, and the body’s immune response first
+ + – produced the antibody IgM, but no IgG was produced or the IgG content did not reach the
detection limit of the diagnostic reagent.
+ – + Patients may be in late or recurrent stage of infection.
Patient is in the active phase of infection, but the human body has developed some immuni-
+ + +
ty to SARS-COV-2 (the persistent antibody IgG has been produced).
Patient may be in the acute phase of SARS-COV-2 infection. At this time, nucleic acid test
– + –
result need to be considered (PCR may be false negative).
Patient may have been infected with SARS-COV-2 in the past, but the patient has been
– – +
recovered or the virus in body has been cleared.
Patient has recently been infected with SARS-COV-2 and is in the recovery stage. Or the
– + +
nucleic acid test result is false negative and the patient is in the active infection stage.

Known Healthy Individuals

COVID-19 IgM/IgG Rapid Test
Positive Negative Total
Positive 0 0 0
IgM
Negative 0 100 100
Positive 0 0 0
IgG
Negative 0 100 100
Total 0 200 200

Confirmed COVID-19 Positive

Seroconversion Timeline Specimens
Evaluation 11-24
4-10 Days Total
Days
Confirmed Positives 10 36 46
COVID-19 IgM Positive 7 34 41
IgM/ IgG
Rapid Test IgG Positive 2 36 38

Confirmed COVID-19 Patient

Specimens & Healthy Individual
COVID-19 IgM/IgG Rapid Test Specimens
Positive Negative Total
Positive 43 0 43
IgM/IgG
Negative 3 100 103
Total 46 100 146

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PROFESSIONAL LAB KIT INCLUDES:

25 Cassettes • 1 Buffer Tube (5mL) • 25 Pipettes (20uL)

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COVISURE™ COVID-19 IgM/IgG Rapid Test

Internal Sales Guidance

What is the COVISURE™ COVID-19 IgM/IgG Rapid Test?

The COVISURE™ COVID-19 IgM/IgG Rapid Test is an IMMUNOASSAY DEVICE designed for use by HEALTH CARE
PROFESSIONALS ONLY. The COVISURE™ COVID-19 IgM/IgG Rapid Test is an IMMUNOASSAY DEVICE designed
for
the presumptive qualitative indication of COVID-19. The key features of this device are:

Provides Positive/Negative Results in 10 ~ 15 Minutes.

Works with fingerstick, whole blood, serum, or plasma sample types.
Increased screening with IgM and IgG antibody detection.
Ideal high-volume screening device of symptomatic PUI to compliment nucleic acid tests.
Clinical Sensitivity 93.3%
Clinical Specificity 100%
Clinical Accuracy 97.9%

How should a Health Care Professional Use this Device?

CONSIDER: SARS-CoV-2 VIRAL INCUBATION & COVID-19 MANIFESTATION

VIRAL SYMPTOM COVID-19

INCUBATION ONSET DURATION VIRAL INCUBATION PERIOD 2.2 – 11.5 days
*1

95%of patients who develop symptoms will within 5.1 days.

97.5%of patients who develop symptoms will within 11.5 days
3-6 WEEKS (CI, 8.2 to 15.6 days) of infection.
*2

Severe Disease
2 WEEKS SYMPTOM ONSET *4
Mild Infections
The most common clinical features at the onset of illness are:
Fever in 99%
95%
Fatigue in 70%
Dry cough in 59%
97.5%

DISEASE COURSE *5
MILD INFECTIONS: Two Weeks
SEVERE DISEASE: Three to Six Weeks

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Whole Blood / Serum / Plasma

(In vitro Diagnostic Use Only)

STEP 1: PREPARE SPECIMEN STEP 2: ADD SPECIMEN STEP 3: ADD BUFFER STEP 5: READ RESULTS

Fingerstick
Capillary
Blood
Add 2~3 Drops
NEGATIVE
of BUFFER to
Add 20uL Whole Blood SAMPLE WELL
Plasma or Serum OR

STEP 4: START TIMER

POSITIVE
Venipuncture
Whole Blood Read Results in
Add 10uL Serum or Plasma 10~15 Minutes

Specimen must be room

temperature and mixed well Add Specimen to SAMPLE WELL
INVALID

THIS TEST has not been reviewed by the FDA.

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.

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 diagnostic should be considered to rule out infection in these individuals.

With This Device

Any Line Even A Faint
Line Is A Line.
Do NOT Compare Line
Intensity To Control Line.

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 Always Innovating
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W.H.P.M.BIORESEARCH & TECHNOLOGY CO., LTD. W.H.P.M.BIORESEARCH & TECHNO

No. 2 Zizhuang Central Street, Jinzhan Town, Chaoyang District, No. 2 Zizhuang Central Street, Jinzhan T
Beijing, China, 100018.Tel: 010-84391888 Beijing, China, 100018.Tel: 010-843918

$ $

* * * * * * * * * * * * * * * * * * * * * * * '(;('(B!(%* * * * ****************** * * * * * * * * * * * * * * '(;('(B

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Service GmbH Medical Device Safety Service GmbH

5 Hannover, Germany Schiffgraben 41, 30175 Hannover, Germany
Tel: 49-511-62628630

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INFORME TÉCNICO PARA LA EMISIÓN DEL CERTIFICADO DE INSCRIPCIÓN EN EL REGISTRO

SANITARIO DE DISPOSITIVOS MÉDICOS DE FABRICACIÓN EXTRANJERA

Fecha de elaboración: 08/04/2020

De conformidad con el (los) análisis técnico (s) y legal realizados para la Emisión del Certificado De Inscripción
En El Registro Sanitario De Dispositivos Médicos De Fabricación Extranjera, correspondiente a la solicitud Nro.
16822274202000000001P, ingresada el 06/04/2020, se emite el siguiente informe:

Datos del producto analizado

Nombre de producto: Reactivos/Kits para Ensayos de DIV, Serología, Virus, Coronavirus

Asociado al Síndrome Respiratorio Agudo, Anticuerpos IgG
Clasificación: DIV DIAG UU G6VIR RIII
Fabricante: W.H.P.M. BIORESEARCH & TECNHOLOGY CO., LTD.
Solicitante: SIDDIQUI GRIJALVA FAWAD AHMED

Resultados

Análisis Documental Técnico

Fecha de elaboración de informe: 2020-04-08 17:19:02

Técnico responsable del análisis: Pablo José Neacato Matheus
Líder responsable del análisis: Marcos Ivan Camba Mora

Resultados del análisis: Aceptado

Conclusión: Aceptado

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IMPORTADORA Y DISTRIBUIDORA
MEDICA FERBOVASA Cía. Ltda.

Juan León Mera N21-291 y Jerónimo Carrión

Edificio Sevilla piso 6 Of 11-12
Quito - Ecuador
(02) 2541-609 / (02) 2546-226 / (02) 2555764

ferbovasa@hotmail.com