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Diagnostic Test Solutions Catalogue

The document provides information about Alpine Biomedicals, a company that develops and produces rapid diagnostic tests. It details the company's history, vision, products, manufacturing capabilities, and research and development. The products cover areas like fertility, HIV, malaria, dengue, hepatitis, and other infectious diseases. Product information like detection limits, specificity, sample types, shelf life and result time are provided.

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Nathan Algrein
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0% found this document useful (0 votes)
117 views12 pages

Diagnostic Test Solutions Catalogue

The document provides information about Alpine Biomedicals, a company that develops and produces rapid diagnostic tests. It details the company's history, vision, products, manufacturing capabilities, and research and development. The products cover areas like fertility, HIV, malaria, dengue, hepatitis, and other infectious diseases. Product information like detection limits, specificity, sample types, shelf life and result time are provided.

Uploaded by

Nathan Algrein
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

PRODUCT

CATALOGUE
ABOUT
ALPINE BIOMEDICALS
Established in 2017, Alpine Biomedicals Pvt. Ltd. is dedicated to research, development,
and production of rapid tests for immuno-diagnostics. The company was started with
a vision to simplify disease detection, make it more affordable, and bring cutting-edge
science & technology to everyday diagnosis. The core focus of our business continues
to be on innovation and the development of new products that will increase testing
and improve patient care.

Since our inception, we have successfully implemented our strategy of growth


through the development and marketing of novel diagnostic tests. The leading
products include rapid tests for detection of Infectious Diseases, Sexually Transmitted
Diseases, Fertility Tests, Respiratory Infection Tests, Drug of Abuse, Cardiac Markers,
and Genetic Disorders. Product validations are performed in comparison to laboratory
standard reference methods such as Elisa or HPLC. The company is ISO 9001:2015 &
ISO 13485:2016 certied.
Current production capacity is about 200 million tests per year. We put our technical
know-how and expertise in product development, manufacturing and product
registration as per our customer's requirement.

Over the years, Alpine has created a position for itself by developing urgently required
products at low cost and commercializing internationally accepted products at
competitive prices. During the pandemic, Alpine was one of the rst Indian companies
to develop and commercialize the complete range of Covid-19 products which were
supplied to Indian government and also exported to different countries worldwide,
including major exports to South-East Asia, Middle East, and Africa.

We welcome discussion with organisations


or individuals wishing to accelerate
development, clinical evaluation and
commercialisation of any novel products
with potential clinical utility.
WORLD CLASS
RESEARCH &
DEVELOPMENT

STATE
OF THE ART
MANUFACTURING
FACILITY

OPEN TO
OEM
OPPORTUNITIES

PRODUCTION
CAPACITY OF
200 MILLION
TESTS ANNUALLY
FERTILITY

Let's Conrm it One Step Urine Pregnancy Test


For the qualitative detection of human chorionic gonadotropin hormone
(hCG) in female urine specimen.
 Limit of Detection : 25mIU/mL of hCG
 Specicity : No cross reactivity with LH, FSH, TSH
 Specimen : Urine
 Suitable for home, laboratory and nursing homes/hospitals use
 Available in the form of Maxi Test, Mini Test, and Dipstick format
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 1, 25, 50 Tests
 Result Time : Within 5 minutes

Let's Conrm it One Step Urine Mid-Stream Pregnancy Test


For the qualitative detection of human chorionic gonadotropin hormone
(hCG) in female urine specimen.
 Limit of Detection : 25mIU/mL of hCG
 Specicity : No cross reactivity with LH, FSH, TSH
 Specimen : Urine
 Hygienic and suitable for home use
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 1, 3, 25 Tests
 Result Time : Within 5 minutes

Let's Conrm it LH Ovulation Rapid Test Device


For the detection of Luteinizing Hormone surge in urine, signalling that
ovulation is likely to occur in next 24-36 hours.
 Limit of Detection : 40mIU/mL of LH
 Specicity : No cross reactivity with hCG, hFSH, hTSH
 Specimen : Urine
 Suitable for home, laboratory and nursing homes/hospitals use
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5 Tests
 Result Time : Within 5 minutes
HIV TESTING SOLUTIONS

Let's Conrm it HIV 1/2 Antibody Rapid Test


HIV 1/2 Antibody Test is a rapid immuno-chromatographic assay for the qualitative
detection of antibodies to HIV-l and HIV-2 in whole blood, serum, or plasma.
 Sensitivity : 100%
 Specicity : 100%
 Specimen : Serum/ Plasma/ Whole blood
 Sample Volume : 25µl (Serum or Plasma or Whole blood)
 No cross-reaction to common diseases like Malaria, Dengue, HCV, HBV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it HIV 4th Generation Ag/Ab Rapid Test


HIV 4th Gen Ag/Ab Test is a rapid immuno-chromatographic assay for the
qualitative detection of antibodies to HIV-1 & HIV-2 and HIV-1 p24
antigen simultaneously in human serum, plasma, or whole blood.
 Early detection of HIV infection because of addition of p24 antigen
in HIV 4th Gen.
 Sensitivity : 100%
 Specicity : 100%
 Specimen : Serum/ Plasma/ Whole blood
 Sample Volume : 25µl (Serum or Plasma or Whole blood)
 No cross-reaction to common diseases like Malaria, Dengue, HCV, HBV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it HIV/Syphilis Combo Rapid Test


HIV/Syphilis Combo Test is a rapid immuno-chromatographic assay
for the qualitative detection of antibodies specic to HIV-1 including
subtype O, HIV 2 and Syphilis (Treponema pallidum) in humans.
 4 line test that detects antibodies to HIV-1, HIV-2 & T. pallidum
 Sensitivity : 100%
 Specicity : 100%
 Specimen : Serum/ Plasma/ Whole blood
 Sample Volume : 25µl (Serum or Plasma or Whole blood)
 No cross-reaction to common diseases like Dengue, HCV, HBV,
Chikungunya, Covid-19, Malaria etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25 Tests
 Result Time : Within 20 minutes
VECTOR BORNE DISEASE

Let's Conrm it Malaria Pf/Pv Antigen Detection Test


The Malaria Pf/Pv Antigen test is a rapid, qualitative and differential
test for the detection of HRP-II antigen of Plasmodium falciparum
and common pLDH of P. vivax antigen in human whole blood.
 Sensitivity : 99%
 Specicity : 100%
 Specimen : Whole blood
 Sample Volume : 5µl (Whole blood)
 No cross-reaction to common diseases like Dengue, HIV, HCV, HBV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it Malaria Pf/Pan Antigen Detection Test


Malaria Pf/Pan Antigen test is a rapid, qualitative and differential
test for the detection of HRP-II antigen of Plasmodium falciparum
& P. vivax (Pv), P. ovale (Po) or P. malariae (Pm) sp. in human blood.
 Sensitivity : 99%
 Specicity : 100%
 Specimen : Whole blood
 Sample Volume : 5µl (Whole blood)
 No cross-reaction to common diseases like Dengue, HIV, HCV, HBV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it S. typhi Antibody Detection Test


S. typhi Antibody is a rapid immuno-chromatographic test for
the differential detection of Salmonella typhi (S. typhi) IgM and IgG
antibodies in human serum or plasma.
 Sensitivity : 100%
 Specicity : 100%
 Specimen : Serum/ Plasma/ Whole Blood
 Sample Volume : 25µl (Serum or Plasma or Whole Blood)
 No cross-reaction to common diseases like Dengue, HIV, HCV, HBV,
Chikungunya, Covid-19, Malaria etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes
VECTOR BOURNE DISEASE

Let's Conrm it Dengue NS1 Antigen Detection Test


The Dengue NS1 Antigen test is a rapid immuno-chromatographic
assay for the qualitative detection of NS1 antigen of Dengue Virus
in human serum or plasma.
 Diagnosis of early clinical phase of Dengue infection
 Detects NS1 antigen from all 4 serotypes (DEN-1, DEN-2, DEN-3
and DEN-4) and their isolates
 Sensitivity : 99%
 Specicity : 100%
 Specimen : Serum/ Plasma
 Sample Volume : 50µl (Serum or Plasma)
 No cross-reaction to common diseases like Malaria, HIV, HCV, HBV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it Dengue Combo NS1 + IgG/IgM Rapid Test


Dengue Combo Antigen+Antibody is a rapid immuno-chromatographic
assay for the simultaneous detection of Dengue NS1 antigen and
differentiation of IgM and IgG antibodies to dengue virus in human
serum/plasma.
 Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and
DEN-4) in case of antigen test
IgM detection indicates recent infection and IgG detection indicates
recent or previous infections in case of antibody test
 Detects NS1 antigen from all 4 serotypes (DEN-1, DEN-2, DEN-3
and DEN-4) and their isolates
 Sensitivity : 99%
 Specicity : 100%
 Specimen : Serum/ Plasma
 Sample Volume : 5µl (Serum or Plasma for antibody test)
50µl (Serum or Plasma for antigen test)
 No cross-reaction to common diseases like Malaria, HIV, HCV, HBV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25 Tests
 Result Time : Within 20 minutes
INFECTIOUS DISEASES
INFECTIOUS DISEASES

Let's Conrm it HBsAg (Hepatitis B) Rapid Test


HBsAg Test is a rapid immuno-chromatographicimmunoassay for
the qualitative detection of Hepatitis B Surface Antigen (HBsAg)
in serum or plasma.
 Sensitivity : 100%
 Specicity : 100%
 Specimen : Serum/ Plasma
 Sample Volume : 50µl (Serum or Plasma)
 No cross-reaction to common diseases like Malaria, HIV, HCV,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it HCV (Hepatitis C) Rapid Test


HCV Antibody Test is a rapid immuno-chromatographic assay
for the qualitative detection of specic antibody to Hepatitis C Virus
in whole blood, serum, or plasma.
 Sensitivity : 100%
 Specicity : 100%
 Specimen : Serum/ Plasma
 Sample Volume : 25µl (Serum or Plasma)
 No cross-reaction to common diseases like Malaria, HIV, HBV, Dengue,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

Let's Conrm it Syphilis/TP Detection Test Card


The Syphilis/TP Detection Test is a rapid immuno-chromatographic
assay for qualitative and differential detection of IgG/IgM antibodies
to Treponema pallidum (TP) in human serum or plasma.
 Sensitivity : 99%
 Specicity : 100%
 Available in both formats : Cassette/Card and Dipstick
 Specimen : Serum/ Plasma
 Sample Volume : 50µl (Serum or Plasma)
 No cross-reaction to common diseases like Malaria, HIV, HBV, Dengue,
Chikungunya, Covid-19, Typhoid etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes
COVID-19 TESTING

Alpine CoviConrm Covid-19 Rapid Antigen test


Alpine CoviConrm COVID-19 antigen Kit is a single pack rapid and
convenient immuno-chromatographic assay for the qualitative detection
of COVID-19 antigen (viral nucleoprotein) from nasal/ nasopharyngeal swab.
 Sensitivity : 98%
 Specicity : 100%
 Specimen : Nasal/ Nasopharyngeal swab
 Sample Volume : 50µl
 No cross-reaction to microorganisms like Inuenza, Adenovirus, TB etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : Single Test Pack
 Result Time : Within 15 minutes
 Can be custom design to generate test report using AI platform

Alpine Covid-19 Rapid Antigen test


Alpine One Step Novel Coronavirus (COVID-19) antigen Kit is a rapid and
convenient immuno- chromatographic assay for the qualitative detection
of COVID-19 antigen (viral nucleoprotein) from nasal/ nasopharyngeal swab.
 Sensitivity : 96%
 Specicity : 100%
 Specimen : Nasal/ Nasopharyngeal swab
 Sample Volume : 50µl
 No cross-reaction to microorganisms like Inuenza, Adenovirus, TB etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25 Tests
 Result Time : Within 15 minutes

Alpine Covid-19 IgG/IgM Antibody Rapid Test


Alpine One Step Novel Coronavirus (COVID-19) Antibody Kit is
a rapid, qualitative and convenient immuno-chromatographic
assay for the differential detection of IgM & IgG antibodies to
COVID-19 virus in human serum, plasma, or whole blood.
 Sensitivity : 92%
 Specicity : 99%
 Specimen : Serum/ Plasma/ Whole blood
 Sample Volume : 10µl (Serum or Plasma) or 20µl (Whole blood)
 No cross-reaction to common diseases like Malaria, Dengue etc.
 Shelf Life : 12 months when stored at 2-30°C
 Pack Size : 5, 50 Tests
 Result Time : Within 15 minutes
DRUGS OF ABUSE (DOA)

Let's conrm it METHAMPHETAMINE Rapid Test


Methamphetamine Rapid Test is a rapid urine screening test
that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated levels
of Methamphetamine in urine.
 Sensitivity : 99%
 Specicity : 100%
 Limit of Detection : 1000ng/mL of METH
 Available in both formats : Cassette/Card and Dipstick
 Specimen : Urine
 Sample Volume : 50µl (Urine)
 No cross reactivity with THC, MORP, hCG, hFSH, hTSH
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25 Tests
 Result Time : Within 20 minutes

Let's Conrm it THC Rapid Test


THC Rapid Test is a rapid urine screening test that can be performed
without the use of an instrument. The test utilizes a monoclonal antibody to
selectively detect elevated levels of THC in urine.
 Sensitivity : 99%
 Specicity : 100%
 Limit of Detection : 50ng/mL of THC
 Available in both formats : Cassette/Card and Dipstick
 Specimen : Urine
 Sample Volume : 50µl (Urine)
 No cross reactivity with METH, MORP, hCG, hFSH, hTSH
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25 Tests
 Result Time : Within 20 minutes
CARDIAC MARKER

Let's Conrm it TROPONIN I Rapid Test


Troponin I (cTnI) Test is a rapid immuno-chromatographic assay
for the qualitative detection of human cardiac Troponin I in whole
blood, serum, or plasma.
 POC test suitable for emergency care in detecting cardiac troponin.
 Limit of Detection : 0.25ng/ml
 Sensitivity : 99%
 Specicity : 100%
 Specimen : Serum/ Plasma/ Whole blood
 Sample Volume : 50µl (Serum or Plasma or Whole blood)
 No cross-reaction to Troponin T or Troponin C
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 25, 50 Tests
 Result Time : Within 20 minutes

GENETIC DISORDERS

Alpine Sickle SCAN Rapid Test


Sickle SCAN Test is a rapid immuno-chromatographic assay for the
diagnosis of sickle cell disorders of hemoglobins A, S, & C using blood.
 Sensitivity : 99%
 Specicity : 99%
 Specimen : Whole blood
 Sample Volume : 5µl (Whole blood)
 No cross-reaction to albumin, Bilirubin, Penicillin, Triglycerides etc.
 Shelf Life : 24 months when stored at 2-30°C
 Pack Size : 5, 20 Tests
 Result Time : Within 10 minutes
A new destination for In-Vitro Diagnostics

GLOBAL FOOTPRINTS

CORPORATE OFFICE INTERNATIONAL PRESENCE


ALPINE BIOMEDICALS PVT. LTD. THAILAND | MALAYSIA | VIETNAM |
#348, Sector-2, Industrial Growth Centre, PHILIPPINES | LEBANON | GULF |
HSIIDC, Saha - 133 104 (AMBALA)
EAST AFRICA | SOUTH AMERICA | TURKEY
Haryana, INDIA.

ALPINE BIOMEDICALS PVT. LTD.


Website : www.alpinebiomedicals.com
Email : [email protected]
[email protected]
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