Meridian is a primary manufacturer of specialized high-quality molecular reagents and offers solutions to a wide range of industries to diagnose and treat diseases, discover new therapeutics or develop tests for environmental, food and cosmetic safety.
Lateral Flow Services Uncut Sheets
Meridian offers lateral flow assay uncut sheets to support your unique manufacturing needs. We provide an easy approach to start your own label of rapid diagnostic tests.
• WHO, ISO and KGMP approved top-tier production facility • Manufacturer for over 1,242 registered assays worldwide • 12 Billion test capacity per year (1 billion tests per month) • Fully automated with GMP processes and control
Structure of a Lateral Flow Immunoassay
Nitrocellulose membrane
Flow
• OEM Service -Specification can be optimized to meet the demands of our OEM partners • High Quality and Optimized Product 20 years of know-how in BSL-3 facility develop and customize products
Sample application pad
Conjugate release pad
Test line antibodies
Control line antibodies
Wicking pad
• Tier pricing structure by purchase volume • Initial testing pack - 21,000 tests (300 sheets) & minimum order unit is 7,000 tests (100 sheets)
Services
Ready-made uncut sheets
OEM manufacturing (uncut sheet assembled into a device)
Custom uncut sheets (contact us to learn more)
www.meridianbioscience.com/lifescience
READY-MADE UNCUT SHEETS: TEST MENU FOR HUMAN DIAGNOSTIC ASSAYS 39 different tests available – Customer is responsible for obtaining regulatory approval and registration under their name/brand. Many assays are approved by several regulatory agencies (CE, WHO, PQ, MFDS, TGA, Health Canada) under specific customer brands.
Respiratory
Gastrointestinal
Vector-Borne
• Influenza Ag • Legionella Ag • Respiratory Adeno Ag • RSV Ag • S.pneumoniae Ag • Strep AAg • TB MPT64 Ag • COVID/Flu Ab Combo 2.0 • COVID-19 Ag 2.0 • COVID-19 M/G Ab 2.0 • COVID-19 Spike IgG
• H.Pylori Ab • H.Pylori Ag
• Chikungunya IgM Ab • Chikungunya IgM/IgG Ab • Dengue IgM/IgG Ab
Hepatitis
• Dengue IgM Ab • Dengue NS1 Ag • Filariasis Ag • Malaria P.fAg
• Anti-HBs • HAV IgM Ab • HBsAg • HCV Ab
• Malaria P.f/P.vAb • Malaria P.f/P.vAg • Malaria P.f/pan Ag • Tsutsugamushi IgM/IgG Ab • Yellow Fever IgM Ab • Yellow Fever IgM/IgG Ab • Zika IgM Ab • Zika IgM/IgG Ab
STDs
• HIV 1/2 Ab (4-lines) • HIV 1/2 Ab (3-lines) • HIV/Syphilis Combo Ab • Syphilis Ab
Others
• Human CRP Ag • Leptospira IgM/IgG Ab • Ebola Ag
To create a lateral flow test from an uncut sheet, all you need is a two-step assembly process: first, cut the sheet into strips and second, assemble into a two-piece plastic cassette. Or alternatively, just keep the assay in the test strip format .
OPTIONAL SERVICE: ASSEMBLY INTO TEST DEVICE
INCLUDES:
• Assembly and packaging cost (including labor costs) • OEM manufacturing (customized laser printing on each device) • Consumables for the final products (OEM): Buffer, device, silica gel, pouch for packaging (also swabs if required) • Product warranty
SENSITIVITY & SPECIFICITY CUSTOMER IS RESPONSIBLE FOR OBTAINING REGULATORY APPROVAL & REGISTRATION UNDER THEIR NAME/BRAND
Respiratory Uncut Sheets
Specification Guidelines
Category
Product Name
Specimen Volume
Testing Time
Specimen
Feature
Certification
NP swab/wash/ aspirate
Sensitivity: 97.44% Specificity: 100% 8-30 mins
Respiratory
Influenza Ag
-
CE-IVD
Sensitivity: 97.67% Specificity: 99.38% LOD: 0.01 μ g/mL
Respiratory
Legionella Ag
Urine
100 μ l
5-15 mins
CE-IVD
Respiratory Adeno Ag
NP swab/Nasal swab NP swab/wash/ aspirate
Respiratory
4 drops
-
15-20 mins
CE-IVD
Sensitivity: 92.45% Specificity: 98.44% 15-30 mins
Respiratory
RSV Ag
-
CE-IVD
Sensitivity: 100% Specificity: 99.26% LOD: 1.56 x 104 CFU/mL Sensitivity: 98.2% Specificity: 99.26% LOD: 3.91 x 105 cells/mL Sensitivity: 100% Specificity: 100% LOD: 2 ng/mL
Respiratory
S. pneumoniae Ag Urine/ CSF
100 μ l
5-10 mins
CE-IVD
Respiratory
Strep A Ag
Throat swab
-
5-15 mins
CE-IVD
Liquid Culture, Solid Culture NP swab/Nasal swab
Respiratory
TB MPT64 Ag
-
10-15 mins
CE-IVD
Respiratory (COVID-19) Respiratory (COVID-19) Respiratory (COVID-19) Respiratory (COVID-19)
COVID/Flu Ag combo 2.0
4 drops
-
15-30 mins
CE-IVD
CE-IVD, WHO EUL, MFDS, TGA, Health Canada
Sensitivity: 95.92-100% (CT: ≤ 25) Specificity: 98.94%
COVID-19 Ag 2.0 NP swab
3 drops
15-30 mins
COVID-19 M/G Ab 2.0 COVID-19 Spike IgG
Sensitivity: 96.82% Specificity: 98.65% 10-15 mins CE-IVD, MFDS
WB/S/P
10-20 μ l
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 100% 10-15 mins
WB/S/P
CE-IVD
GI, STD, Hepatitis, Other Uncut Sheets
Specification Guidelines
Category
Product Name
Specimen Volume WB: 20 μ l, S/P: 10 μ l
Testing Time
Specimen
Feature
Certification
Gastrointestinal
H.pylori Ab
WB/S/P
-
10-20 mins
CE-IVD
Sensitivity: 98.5% Specificity: 100% LOD: 0.97 ng/mL
Gastrointestinal
H.pylori Ag
Feces
40-70 mg
10-15 mins
CE-IVD
HIV 1/2 Ab (4-lines) HIV 1/2 Ab (3-lines)
WB: 20 μ l, S/P: 10 μ l WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 98.8% 10-20 mins
STDs
WB/S/P
-
Sensitivity: 99.8% Specificity: 100% 10-20 mins
STDs
WB/S/P
WHO PQ
* HIV Ab Sensitivity: 100% Specificity: 99.9%* Treponema Pallidum Ab Sensitivity: 98.8% Specificity: 100%
HIV/Syphilis Combo Ab
WB: 20 μ l, S/P: 10 μ l
STDs
WB/S/P
15-20 mins
WHO PQ
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 100% 5-20 mins
STDs
Syphilis Ab
WB/S/P
CE-IVD
Sensitivity: 98.5% Specificity: 98% 15-30 mins Sensitivity: 100% Specificity: 98.04% 15-20 mins Sensitivity: 100% Specificity: 100% 20-30 mins
Hepatitis Hepatitis Hepatitis
Anti-HBs
WB/S/P WB/S/P WB/S/P
100 μ l
- - -
HAV IgM Ab
10 μ l
HBsAg
100 μ l
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 97.67% 5-20 mins WHO PQ, CE-IVD
Hepatitis
HCV Ab
WB/S/P
Others
Human CRP Ag Leptospira IgM/ IgG Ab
WB/S/P
5 μ l
-
3 mins
CE-IVD
Sensitivity: 96.6% Specificity: 98.6% 15-20 mins
Others
WB/S/P
10 μ l
CE-IVD
Others
Ebola Ag
WB/S/P
100 μ l
-
20-30 mins
CE-IVD
www.meridianbioscience.com/lifescience
WB: Whole Blood. S: Serum. P: Plasma. NP: Nasopharyngeal
CUSTOMER IS RESPONSIBLE FOR OBTAINING REGULATORY APPROVAL & REGISTRATION UNDER THEIR NAME/BRAND
GI, STD, Hepatitis, Other Uncut Sheets
Specification Guidelines
Category
Product Name
Specimen Volume
Specimen
Feature
Testing Time Certification
Chikungunya IgM Ab
Vector-borne
-
-
-
-
-
Chikungunya IgM/IgG Ab
Sensitivity: 97.7% Specificity: 99.6% 15-20 mins
Vector-borne
WB/S/P
10 μ l
CE-IVD
Dengue IgM/IgG Ab
Sensitivity: 97.5% Specificity: 97.2% 15-20 mins
Vector-borne
WB/S/P
10 μ l
CE-IVD
Vector-borne Dengue IgM Ab
-
-
-
-
-
Sensitivity: 92.9% Specificity: 98.7% LOD: 0.5 ng/mL
Vector-borne Dengue NS1 Ag
WB/S/P
100 μ l
15-20 mins
CE-IVD
Sensitivity: 100% Specificity: 100% 10-20 mins
Vector-borne
Filariasis Ag
WB/S/P
2 drops
CE-IVD
Tsutsugamushi IgM/IgG Ab Yellow Fever IgM Ab Yellow Fever IgM/ IgG Ab
Vector-borne
WB/S/P
10 μ l
-
15-20 mins
CE-IVD
Sensitivity: 100% Specificity: 98.3% 15-20 mins
Vector-borne
WB/S/P
10 μ l
CE-IVD
Vector-borne
-
-
-
-
-
Sensitivity: 98% Specificity: 100% 15-20 mins
Vector-borne
Zika IgM Ab
WB/S/P WB/S/P
10 μ l 10 μ l
CE-IVD CE-IVD
Vector-borne Zika IgM/IgG Ab
-
15-20 mins
* Venous Whole Blood Sensitivity: 99.59% Specificity: 100% * Capillary Whole Blood Sensitivity: 99.38% Specificity: 100%
Vector-borne
Malaria P.f Ag
WB
5 μ l
15-30 mins CE-IVD, WHO PQ
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 97.6% Specificity: 96.9% 5-20 mins
Vector-borne Malaria P.f/P.v Ab
WB/S/P
-
* Venous Whole Blood Sensitivity: P.f 99.59%, P.v 100% Specificity: 100% * Capillary Whold Blood Sensitivity: P.f 99.38%, p.v 100% Specificity: 100% * Venous Whole Blood Sensitivity: P.f 99.58%, P.v, P.m. and P.o. confirmed specimen on pan
Vector-borne Malaria P.f/P.v Ag
WB
5 μ l
15-30 mins CE-IVD, WHO PQ
100% Specificity: 100% * Capillary Whold Blood
Malaria P.f/pan Ag
Vector-borne
WB
5 μ l
15-30 mins CE-IVD, WHO PQ
Sensitivity: P.f 99.68%, P.v, P.m. and P.o. confirmed specimen on Pan 100% Specificity: 100%
WB: Whole Blood. S: Serum. P: Plasma. NP: Nasopharyngeal
Ordering information: USA 5171 Wilfong Road Memphis, Tennessee 38134 Phone: +1 901-382-8716 Fax: +1 901-333-8223
Email: info@meridianlifescience.com Orders: orders@meridianlifescience.com www.meridianbioscience.com/lifescience
Connect with us:
ISO 13485 Certified
03/23
Page 1 Page 2 Page 3 Page 4Powered by FlippingBook