Fluorescence Immunoassay Product

Catalogue

Q8 Pro and Test Menu

POCT

www.zybio.com
About Zybio

Zybio Inc. (referred to as “Zybio”) is a national high tech enterprise founded in 2008, one of the lead-
ing Chinese medical companies dedicated in a comprehensive line of IVD reagents and equipment,
including Hematology, Chemistry, CLIA, POCT, Molecule, Microbiology.

Since the beginning, Zybio has implemented high standard in all aspects in terms of research &devel-
opment, production, marketing, sales and technical services, to satisfy the needs of our users.

Now, there are over 3000 employees totally and one-third of them are engaged in R&D, of which
more than 50% have a master's degree or above.

We have built 8 R&D centers in China, including Chongqing R&D center, Shanghai R&D center,
Guangzhou R&D center, Shenzhen R&D center, Beijing R&D center, Xiamen R&D center, Changchun
R&D center and Nanjing R&D center. Strong R&D team guarantees more diverse and high-quality
product, which drives us forward. In addition, we have an independent service center allocating more
than 100 service or application engineers to serve our clients throughout the world.

Based on the ideology of “plan together, create together, share together”, we have set up a network
of operations throughout China and keep expanding globally.
Fluorescence Immunoassay
Analyzer (Q8 Pro)

Q8 Pro is a quantitative POCT analyzer based on dry

immunoassay fluorescence technology that integrates
operation, analysis, and result display. It can automati-
cally complete a series of operations includes test card
loading, item identification, incubation, detection, card
discarding and results print within 10 minutes.
Features

User-friendly Intelligent

15-inch colorful touch screen, intuitive software interface Maintenance free

25-chanels, up to 25 different items in one time Real-time monitoring
External solid waste container, easy to maintenance and Power-off protection, and ready to storage test result
environment friendly Temperature stable incubator

Patient
Patient Name Item Status/Result Information
Sample
cTnl 1.10ng/mL ̓
0.50ng/mL̓ Edit
202004100001 MinGuo Li CK-MB
Myo 2.30ng/mL̓

Accurate Convenient

Automatically recognize item information Multi-sample types, includes serum, plasma, urine
Stable photoelectric signal Time to result within 10 minutes
Time resolution fluorescence immunoassay technology, Free calibration system
higher sensitivity and wider detection range Result transmission by LIS
Online software update
Technical Advantages

The highly sensitive Time-Resolved Fluorescence Immunoassay Exciting Light 1000

(TRFIA) was developed for quantitative determination of target ĝ=340nm Cycle/Second
Background Fluorescence Signal
analytes from human sample such as plasma, serum and whole
blood on Q8 pro analyzer. The selective Lanthanides molecular Lanthanide Fluorescence Signal

Fluorescence Intensity
was used to label antibody or antigen. Autofluorescence is
emitted by most biological samples and is usually a limiting factor
for assay sensitivity. Since it decays in nanoseconds, time-re-
solved fluorescence measurements in the micro- or milli-second
range allow to detect the emission signal of the lanthanides upon
exhaustion of the autofluorescence signal, which can reduces
the background noise and improve the sensitivity of assay.
0 200 600 1000
Delay Time Detection Time Time(ns)

Figure 1: Fluorescence signal decay time comparison

Parameters

Principle Fluorescence Immunochromatography Storage Capacity 100,000 tests

Channel 25 Software Update By USB or internet

Test Time 3-15 min Power Supply 100-240V~, 50/60 Hz, 150 VA

Sample Type Whole blood, capillary blood, serum, plasma Temperature 10~30°C

Relative Humidity 30%~85%

Incubation
37.0°C±1.5°C
Temperature
Air Pressure 70~106 KPa

Data Transmission LIS Altitude 3000 m

Operation System Windows 10 Dimension 416 mm × 395 mm × 404 mm

Display 15-inch Weight 18 Kg

Test menu

Panel Test Items

Inflammation CRP, SAA, PCT, IL-6*

Cardiac Markers D-Dimer, NT-proBNP, cTnT, 3 in 1(cTnT/CK-MB/Myo ), cTnI*

Bone metabolic 25-OH Vitamin D*

Thyroid TSH*, T3*, T4*

DM HbA1c

SARS-CoV-2 SARS-CoV-2 Neutralizing Antibody, SARS-CoV-2 Antibody

* Coming soon
T3, T4, TSH

Serological tests of thyroid function include total thyroxine (T4), total triiodothyronin (T3), free thyroxine (FT4), free triiodothyronin
(FT3), thyroid stimulating hormone (TSH), etc. It is an important part of diagnosing and treating thyroid disorders. While some
conclusions can be drawn from a single test, a combination of test results are usually needed to establish the full nature of your
thyroid health. By comparing the values of thyroid tests, a doctor can determine whether a person has hypothyroidism (people with
low thyroid function), hyperthyroidism (people with overactive thyroid), or an autoimmune thyroid disease such as Graves' disease
or Hashimoto's thyroiditis.

Hypothalamus Thyroid gland TRH Thyroid Releasing Hormone

Negative feedback TSH Thyroid Stimulating Hormone
TRH inhibition T3 Triiodothyronine Hormone
T4 Thyroxine Hormone
Pituitary gland TSH
T3 T4 C
Calcitonin

Interpretation for Thyroid Function Test

High T3/T4 Normal T3/T4 Low T3/T4

Pituitary hyperthyroidism
High TSH Subclinical hypothyroidism Primary hypothyroidism
Thyroid hormone resistance

Sampling within 6 h of Pituitary or hypothalamic hypothyroidism

Normal TSH Normal
thyroxine dose Severe non-thyroidal illnessv

Subclinical hyperthyroidism
Subtle thyroxine overreplacement Pituitary or hypothalamic hypothyroidism
Low TSH Hyperthyroidism
Autonomous functioning thyroid nodule Severe non-thyroidal illness
Non-thyroidal illness

Parameter

Time to
Panel Test Item Sample Type Sample Volume Measuring Range Reference Range Qualification
Result

Whole blood / 100 μL for whole blood

TSH 15 min 0.1-100.0 mIU/L 0.3 mIU/L-4.2 mIU/L CE
plasma / serum 70 μL for serum/plasa

Thyroid Whole blood /

T3 15 min Diluted sample: 70uL 0.5-10.0 nmol/L 1.23 nmol/L-3.07 nmol/L CE
Function plasma / serum

Whole blood /
T4 15 min Diluted sample: 70uL 12.87-310.0 nmol/L 66-181 nmol/L CE
plasma / serum

Order Information

Test Item Catalog No. Test/kit Unit Quantity Available Systems

TSH 2013801 25 T/Kit Kit 1 Q8 pro

T3 2013601 25 T/Kit Kit 1 Q8 pro

T4 2013701 25 T/Kit Kit 1 Q8 pro

CPR, SAA, IL-6*, PCT

Infection Marker PCT

(pg/mL)
20
Infectious diseases are one of the most common clinical

Inflammatory Factor Concentration

diseases. Due to the diversity of routes of infection, the variety CRP
IL-6 (pg/mL)
of pathogens, and individual differences in symptoms and (pg/mL)
15
signs, delayed diagnosis and treatment maybe occurs. There-
fore, it is particularly important to distinguish the infection type
of patients when infectious diseases occur.
10 IL-10
The four inflammatory tests (PCT/IL-6/SAA/CRP) can help (pg/mL) SAA
(mg/mL)
quickly and effectively identify the types of infection in
patients, which can not only alleviate the lack of diagnosis TNF-ē
(pg/mL)
speed, but also classify the diagnosis, avoiding the misuse of 5
antibiotics and the waste of scarce medical resources during
the critical period.
0
0 1 2 6 12 24 48 72
Time ( h )

CRP SAA PCT IL-6*

Virus infection increased Bacterial and viral infections,

The most specific markers
Bacterial infections significantly, bacterial mycoplasma infections,
of bacterial infection and
Clinical Features increased, and some viral infection increased greatly, malignant tumors, severe
sepsis can be used to
infections increased decreased greatly when tissue damage, autoimmune
monitor antibiotic use
infection is cured diseases, etc.

Dynamic Rising stage: 6-12 h Rising stage: 8 h Rising stage: 2-4 h Rising stage: 0-1 h
Characteristi Platform stage: 24-48 h Platform stage: 5-6 h Platform stage: 12-48 h Platform stage: 2 h
c

Local Inflammation

Bacterial Infection

Viral Infection

Fungal Infection

Clinical Value Most commonly used Virus infection preference Most specific Most sensitive

Application CS panel: Outpatient service, etc. (Upper respiratory IP panel: Multi-department and multi-scene (Inpatient and
Scenarios tract or gastrointestinal tract infection) emergency department, Different disease states)
Parameter

Reaction
Panel Test Item Specimen Type Specimen Volume Measuring Range Reference Range Qualification
Time

Whole blood / hs-CRP < 1 μg/mL,

CRP 3 min Diluted sample: 60uL 0.5-200 µg/mL CE, NMPA
plasma / serum CRP < 10 μg/mL

Whole blood /
SAA 3 min Diluted sample: 60uL 3-200 μg/mL SAA <10 ug/mL CE, NMPA
plasma / serum
Infection
Marker
Whole blood / 100 μL for whole blood
PCT 10 min 0.1-100.0 ng/mL PCT < 0.5 ng/mL CE, NMPA
plasma / serum 60 μL for serum/plasa

Whole blood / 100 μL for whole blood

IL-6* 15 min 5~4000 pg/mL < 7pg/mL CE, NMPA
plasma / serum 70 μL for serum/plasa

Performance

250 60 250

50
200 200

40
150 150

Q8 pro
Zybio

Zybio

30

100 100
20

50
y = 0.9739x + 1.9696 y = -0.0130555 + 0.921033x 50 y = -0.367387 + 1.093945x
10
R² = 0.9568, N=215 N=200 R² = 0.9476, N=141

0 0 0
0 50 100 150 200 250 0 10 20 30 40 50 60 0 50 100 150 200 250

Beckman Beckman EXC 200

CRP comparision test between Zybio PCT comparision test between Zybio SAA comparision test between Q8
and Beckman Q8 pro and Roche cobas e 411 pro and EXC200 ( Chemistry analyzer)

Order Information

Test Item Catalog No. Test/kit Unit Quantity Available Systems

CRP 2012501 25 T/Kit Kit 1 Q8 pro

SAA 2013101 25 T/Kit Kit 1 Q8 pro

IL-6* 2013901 25 T/Kit Kit 1 Q8 pro

PCT 2013001 25 T/Kit Kit 1 Q8 pro

HbA1c

Diabetic Markers

A hemoglobin A1c (HbA1c) test measures the amount of HbA1c (mmol/mol and %)

blood sugar (glucose) attached to hemoglobin. Hemoglobin is 64 75

53 8% 9% 86
the part of your red blood cells that carries oxygen from your 7% 10%
42 97
lungs to the rest of your body. An HbA1c test shows what the 6% 11%
average amount of glucose attached to hemoglobin has been 31 108
5% 12%
over the past three months. It's a three-month average
because that's typically how long a red blood cell lives. 10.2 11.8
8.6 13.4
7.0 14.9
If your HbA1c levels are high, it may be a sign of diabetes, a 5.4 Blood Glucose 16.5
(mmol/L)
chronic condition that can cause serious health problems,
including heart disease, kidney disease, and nerve damage. HbA1c as an indicator of diabetes control

Parameter Performance

14
Panel Diabetic
12
Test Item HbA1c
10
Reaction Time 5 min
Zybio

8
Specimen Type Whole blood
6
Specimen Volume Diluted sample: 70uL
4 y = -0.786552 + 1.123957x
Measuring Range 4.0 - 14.0% R=0.952, N=379

2
Reference Range 4.0%~6.0% 2 4 6 8 10 12 14

Arkray
Qualification CE, IFCC, *NGSP

NGSP certification is on process HbA1c comparision test between Zybio and Arkray

Order Information

Test Item Catalog No. Test/kit Unit Quantity Available Systems

HbA1c 2013501 25 T/Kit Kit 1 Q8 pro

25-OH-VD

Bone metabolic
Sunlight

Vitamin D is a kind of fat-soluble vitamins, is a multi-functional

Skin
hormone can maintain a healthy body, which plays an import-
ant role on the control of calcium phosphate levels in the body
and bone calcification. In addition, vitamin D plays an import- 7-Dehydrocholesterol

ant role in the function of many systemic systems, including

cardiovascular system, immune system, nervous system, Cholecalciferol
(vitamin D3)
glucose metabolism, cell proliferation and differentiation, etc.

Total vitamin D can be converted to 25-hydroxyvitamin D in

Liver (25-hydroxyase) Dietary intake
the liver and further hydroxylated to the active 1, 25-dihy-
Vitamin D3 (fish, meat)
droxyvitamin D in the kidney. Vitamin D2 (supplements)

The 25-hydroxy vitamin D test is the most accurate way to

measure how much vitamin D is in your body.
25-hydroxyvitamin D2/D3

Kidney

1,25-dihydroxyviyamin D2/D3
Maintains calcium balance in the body

Parameter

Reaction
Panel Test Item Specimen Type Specimen Volume Measuring Range Reference Range Qualification
Time

Whole blood /
Vitamin 25-OH-VD 15 min Diluted sample: 70uL 5.0~120.0 ng/mL ≥30 ng/mL CE
plasma / serum

Order Information

Test Item Catalog No. Test/kit Unit Quantity Available Systems

25-OH-VD 2014101 25 T/Kit Kit 1 Q8 pro

NT-proBNP, D-Dimer, cTnT, cTnI, 3 in 1 (cTnT/CK-MB/Myo)

Cardiac Markers

Acute myocardial infarction (AMI) is a major cause of morbidity and mortality worldwide. The highest risk of fatality occurs within the
initial hours of onset of AMI. Thus, early diagnosis of cardiac ischemia is critical for the effective management of patients with AMI.
Myo is a preferred early indicator for the diagnosis of acute myocardial infarction (AMI). CTnI is a highly specific indicator for the
diagnosis of AMI. Ck-mb is less sensitive than Myo or cTnI, but it is of certain value in the diagnosis of early post-AMI reinfarction.-
Clinical evidence shows that any single test result has the possibility of misdiagnosis and missed diagnosis, and combined test is
more conducive to the early and accurate diagnosis of AMI.

NT-proBNP is measured as a simple blood test to help diagnose and monitor heart failure. It’s released in response to changes in
pressure inside the heart. These changes can be related to heart failure and other cardiac problems. Levels goes up when heart
failure develops or gets worse, and levels goes down when heart failure is stable.

A NT-proBNP test is most often used to diagnose or rule out heart failure. The test is particularly useful in hospital emergencies to
help distinguish heart failure from severe lung damage, which often has the same symptoms. In an outpatient setting, the test is
useful for monitoring disease progression and the effects of treatment.

Myocardial
infarction

Coronary Arrhythmia &

cTn, CK-MB, Myo
thrombosis loss of myocardium

Myocardial
Remodelling
ischemia

NT-proBNP

CAD LV dilation

Atherosclerosis Chronic
LVH Heart Failure
Acute
Heart Failure

Risk factors Death

Hypertension Cholesterol Diabetes Nicotine

Parameter

Reaction
Panel Test Item Specimen Type Specimen Volume Measuring Range Reference Range Qualification
Time

under 75 years old

Whole blood / 100 μL for whole blood <125 pg/mL
NT-proBNP 10 min 30-35000 pg/mL CE, NMPA
plasma / serum 60 μL for serum/plasa Over 75 years old
<450 pg/mL

Whole blood / 100 μL for whole blood

D-Dimer 5 min 60 μL for serum/plasa 0.2-20 μg/mL D-Dimer < 0.5 μg/mL CE, NMPA
plasma / serum

Cardiac Whole blood / 100 μL for whole blood

cTnT 10 min 0.01-10.00 ng/mL cTnT < 0.04 ng/mL CE, NMPA
Markers plasma / serum 60 μL for serum/plasa

Whole blood / 100 μL for whole blood CE

*cTnI 15 min 0.10~50.00ng/mL 0-0.3 ng/mL
plasma / serum 70 μL for serum/plasa

3 in 1
cTnT: 0.01-10.00 ng/mL cTnT < 0.04 ng/mL
(cTnT/ Whole blood / 100 μL for whole blood
10 min CK-MB: 1-80 ng/mL CK-MB < 5 ng/mL CE, NMPA
CK-MB plasma / serum 60 μL for serum/plasa
Myo: 5-500 ng/mL Myo < 72 ng/mL
/Myo )

Performance

35000 20

18
30000
16

25000 14

12
20000
Zybio

Zybio

10
15000
8

10000 6
y = 0.8519x + 311.96 4 y = -0.0104754 + 0.865853x
5000 R² = 0.9646 R² = 0.8081
2

0 0
0 5000 10000 15000 20000 25000 30000 35000 0 5 10 15 20

Roche Sysmex

NT- pro BNP comparision test between Zybio and Roche D-Dimer comparision test between Zybio and Sysmex
 10

6
Zybio

2 y = 1.0993x + 0.1426
R² = 0.9163

0
0 1 2 3 4 5 6 7 8 9 10

Roche

cTnT comparision test between Zybio and Roche

Order Information

Test Item Catalog No. Test/kit Unit Quantity Available Systems

NT-proBNP 2012701 25 T/Kit Kit 1 Q8 pro

D-Dimer 2012601 25 T/Kit Kit 1 Q8 pro

cTnT 2012801 25 T/Kit Kit 1 Q8 pro

cTnI* 2014001 25 T/Kit Kit 1 Q8 pro

3 in 1(cTnT/CK-MB/Myo ) 2012901 25 T/Kit Kit 1 Q8 pro

SARS-CoV-2 NAb, SARS-CoV-2 Total antibody

COVID-19

The pandemic (i.e. COVID-19) and mutated variants continuously threatens throughout the world.

RT-PCR (fluorescent probe) method remains as golden standard for COVID-19 diagnosis, though due to lack of proficient sampling
operation, as well as stage of patient's infection, there are false negatives occurred at a minor possibility.

SARS-CoV-2 antibody tests could be a supplementary detection for suspected cases with negative test of SARS-CoV-2 nucleic
acid tests or in conjunction with nucleic acid assay in the diagnosis of suspected cases.

As COVID-19 vaccination continues to deepen, SARS-CoV-2 neutralizing antibody detection comes into being.

SARS-CoV-2 Neutralizing Antibody detection is a valuable tool in measuring the effectiveness of vaccines and help detection of
neutralizing antibody in human with infected or suspected SARS-CoV-2.

What’s the differences between SARS-CoV-2 antibody and neutralizing antibody?

S-RBD IgG
S-RBD IgG is limited to IgG subtypes that target
the S-RBD site NAb
NAb include but are not limited to S-RBD sites,
there may be a small number of S-NTD sites and
Total S-RBD
different antibody subtypes
Total S-RBD antibodies are limited to S-RBD sites,
including different antibody subtypes

Parameter

Reaction Target Measuring Reference

Panel Test Item Specimen Type Specimen Volume Qualification
Time Protein Range Range

SARS-CoV-2
Whole blood / 100 μL for whole blood
Neutralizing 10 min S-RBD 0.03-10 U/mL < 0.3 U/mL CE
plasma / serum 60 μL for serum/plasa
Antibody
COVID-19

SARS-CoV-2 Whole blood / 100 μL for whole blood

10 min S-RBD Qualitative Negative CE
Antibody plasma / serum 60 μL for serum/plasa

Order Information

Test Item Catalog No. Test/kit Unit Quantity Available Systems

SARS-CoV-2 Neutralizing Antibody 2110201 25 T/Kit Kit 1 Q8 pro

SARS-CoV-2 Antibody 2100201 25 T/Kit Kit 1 Q8 pro

Zybio Inc.
Address: Floor 1 to Floor 5, Building 30, No.6 of Taikang Road,
Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing,
PEOPLE'S REPUBLIC OF CHINA
Tel: +86-23 6865 5509 Fax: +86-23 6869 9779
Email: info@zybio.com Website: www.zybio.com

EN-C-POCT-Q8 pro-R-20220224H

POCT

www.zybio.com