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COVID-19

MiCo BioMed has been firmly standing at the forefront of the global
fight against COVID-19, providing comprehensive diagnostic solutions.

Rapid Diagnostic test
CE · RUO

CE · RUO

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Specification
VERI-Q COVID-19 Ag Rapid Test CE · RUO
VERI-Q COVID-19 Ag Rapid Test
Reaction Principle

Chromatographic immunoassay

 Sample Type

Nasal Swab or Nasopharyngeal Swab
Test Results

Negative or Positive

 Test Time

Less than 20 minutes for standard test
Storage condition

Device : 2 ~ 30℃

Extraction Reagent : 2 ~ 30℃
Contents

Individually pouched device with a desiccant (20 ea)

Reagent Tube with Filter Cap(20ea)

Extraction Reagent(5mL x 2 bottles)

Instructions for use (1 ea)

Sterilized Nasal Swab(20ea)
VERI-Q COVID-19 lgG/lgM Rapid Test CE · RUO
VERI-Q COVID-19 Ag Rapid Test
Reaction Principle

Chromatographic immunoassay

 Sample Type

Whole blood(Capillary, Venous, Serum or Plasma)
Test Results

Negative or Positive

 Test Time

Less than 20 minutes for standard test
Storage condition

Device : 2 ~ 30℃

Extraction Reagent : 2 ~ 30℃
Contents

Individually pouched device with a desiccant (20 ea)

Instructions for use (1 ea)

20 uL Capillary tubes (20 ea)

Buffer solution 4mL (1 ea)
Result Interpretations
VERI-Q COVID-19 Ag Rapid Test CE · RUO
VERI-Q COVID-19 Ag Rapid Test
Nagative

A pink colored band appears only at the control line(C),
indicating a negative result for COVID-19 Infections.
Positive

A clear pink control band(C) and a detectable pink test band(T) appears,
indicating a positive result for COVID-19 infections.
Invalid

No visible band appears at the control line(C).
Repeat with a new test kit. If the test still fails, please contact the distributor with the lot number.
VERI-Q COVID-19 Ag Rapid Test CE · RUO
VERI-Q COVID-19 Ag Rapid Test
Nagative

A pink colored band only at the control region (c) represents
“COVID-19 negative”.
Positive

Pink colored bands at control region (c) and lgG (G) and /or lgM (M) region indicate “COVID-19 positive”.

1) Pink colored bands at both lgM (M) and lgG(G): “COVID-19 positive”

2) Pink colored bands at lgM (M) alone: “COVID-19 positive”

3) Pink colored bands at lgG(G) alone: “COVID-19 positive”.
Invalid

No visible band at the control region (C). Repeat with a new test device.
If test still fails, please contact the distributor with the lot number.
Enzyme-Linked Immunosorbent Assay
CE · RUO

CE · RUO

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Clinical Perfomence
Clinical Agreement using RT-PCR Test Result as the Comparator Method
VERI-Q COVID-19 Ag Rapid Test

Comparator Method (RT-PCR Result)

Positive (n=36)

Negative (n=180)
Positive

34

0
Negative

2

180
Clinical Sensitivity(PPA)

94.4% (95% CI : 81.86%-98.46%)

Clinical Specificity (NPA)

100% (95% CI :97.91%-100%)
PPV for prevalence=5%

100% (95% CI : 89.59%-100 %)

NPV for prevalence=5%

98.9% ( 95% CI :96.08%-99.70%)
Clinical Agreement using Predicate ELISA kit1) test Result
VERI-Q COVID-19 Ag Rapid Test

Predicate ELISA kit1)

Positive (n=34)

Negative (n=182)
Positive

34

0
Negative

0

182
Clinical Sensitivity(PPA)

100% (95% CI : 89.85%-100.0%)

Clinical Specificity (NPA)

100% (95% CI : 97.93%-100.0%)

Predicate ELISA kit : GenScript cPassTM SARS-CoV-2 Neutralization Antibody Detection Kit

Clinical Perfomence
Antigen-antibody reaction Reader

Antigen-antibody reaction Reader