ISO Certified Widal Slide AH BH Antigen Slide And Tube Test KIt

WIDAL TEST-4X5 ML

Intended use:
Test for determination of antibodies against Salmonella antigens by Slide & Tube Test method.

Introduction:

Salmonella typhi & Salmonella paratyphi are the causative agents of "Enteric Fever". The antigens of typhoid and paratyphoid consist of 2 distinct fractions – the stable somatic 'O' antigen and the labile flagellar 'H' antigen. The paratyphoid antigens are further classified into 'A' and 'B' species. In typhoid and paratyphoid, the 'H' antigen is type specific whereas the 'O' antigen is group specific.

Method Principle:

Widal antigens are the standardized smooth suspension of killed bacterial antigens of qualitative and semi-quantitative detection of S. typhi and S. paratyphi antibodies. An undiluted serum is used in slide test. It is simple, rapid and convenient screening test. The slide test are standardized in such a way that they can be used for either slide or tube technique. In doubtful cases, it is recommended to perform the tube technique for obtaining conclusive results. A marked rise in the titre to one serotype (above 1:80) suggests infection. Diagnostically, a rising antibody titre of at least four-fold (two tube difference) is considered more significant than a single test. It is observed that individuals immunize with TAB vaccine may show a moderately high titre for all antigens.

WHO WE ARE

Established in 1998, Anamol Laboratories Pvt. Ltd. today is synonymous with Quality and Consistency. The very name of Anamol comprises two separate words combined together as one which are "ANA" and "MOL" which means "ANALYSIS of MOLECULES", explaining our core strength in understanding Chemistry and Biochemistry as a subject and how different molecules interact with each other. It is because of this in-depth knowledge that we can elevate our products to international standards or better. The power of current knowledge base and zeal to acquire new knowledge with the same depth and clarity has helped shape our core competency and gain trust from people within and outside the industry for close to two decades now.

WHAT WE DO?

\tWe are highly sophisticated and professional manufacturers of Clinical Chemistry Reagents, Rapid Immunoassays, Urine Tests Strips, Immunology reagents, Dyes and Stains for Fluorometry and many others. Every product we develop, we keep in mind how we would help spread the confidence of an accurate diagnostic report to the Medical Practitioner as well as to the Patient. It is because of this goal at our hearts, we believe in adding value to the product to remain competitive and improve our Value Proposition.

OUR FACILITY

We have a state-of-the-art production facility of around 27,000 square ft. located in Palghar (Near Mumbai), Maharashtra, India which is just 100 km away from ChhatrapatiShivaji International Airport, Mumbai, India. The location is well connected to Rail, Road, Sea and Air for multiple modes of transportation of products. The entire facility has been certified by Food and Drugs Administration (Schedule M), Government of India. Our facility is GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) certified. All operations are governed through ISO 9001:2015 and ISO 13485:2003 Quality Management Systems. The latest equipments and infrastructures empowers the manufacturing of 2000 liters of liquid reagents being taken up from formulations to bottling as final product on daily basis. Current plant capacity from raw materials to finished goods exceeds 3 million tests/day. The entire manufacturing process is done is controlled environment of humidity, particle-free zones and class 10,000 production rooms. Systems and multiple auto-check points have helped ALPL to run 4 different production lines simultaneously with zero error to achieve maximum production. 

VISION
To contribute in adding disease-free years in human life.

MISION
We shall strive to achieve trust of our customers by providing them dependable diagnosis through our products.

To achieve global footprint as one of the most reliable and preferred healthcare company.

VALUES 

Customer Commitment:
We are concerned to meet our customer's changing needs and expectations from time to time and to design innovative and user-friendly solutions having high value propositions to address the same.

Win-Win Relationship:
We strive to build a long-lasting and mutually beneficial collaboration with all our stakeholders.

Accountability:
We remain accountable for quality of our people & products and to work towards their betterment everyday.

Knowledge Management:
We have quest to acquire, implement and share knowledge pool with all our stakeholders.

Ethics:
Being Ethical, Honest and Transparent in our conduct is at the very root of our business.

At Anamol Laboratories Pvt. Ltd., we believe quality is a result of a series of well-planned actions to achieve a specific objective. In case of diagnostic test system, the ultimate purpose is patient benefits and affordability. Our role as a manufacturer is critical as any manufacturer puts his willingness to build good quality or otherwise.

"Customer First"

\tQuality is an experience of the customer. Product quality perception comes from specifications of product design and the manufacturing standards achieved. Because of this reason, "Customer First" is our philosophy. We are well aware of the fact that quality in our products or service is not what we put in but what our customers take out. It is always our sincere attempt to sell not just a product, but value and experience.

Competency and Attitude

\tQuality starts well before the purchase of raw materials. Building good quality is a matter of choice. One may have a complete attitude to build a great quality product or service but may lack the necessary skills and competency to do so. On the other hand, one may have all the skill-sets and knowledge to build a great product or service but may not have the willingness or desire to do so. We believe it takes a balanced combination of both Competency and Attitude to create quality. Our attitude to create quality always pushes us from our comfort zones to acquire or upgrade our competencies. The vast experience and knowledge of the team members acts as bonus over existing culture.

Research and Development

\tWith changing times, the needs of markets and customers change. Our continuous R&D activity helps us to create new products and solutions for the changing needs or to add new features in our current products by challenging conventional performance limitations. Our R&D specifications clearly define purpose of diagnostic test systems such as Accuracy levels, Sensitivity limits, Precision (within and between run), Linearity, Interferences, Uncertainty, Traceability to international standards, etc. We communicate and remain in close contact with our customers to understand their requirements. In other words, our customers play an important role to guide us for our future activities.

Raw Materials

\tMost of the enzymes used by us are Genetically Engineered (GE) grade from the best sources across the globe leading to high sensitivity, specificity and performance characteristics. We employ Zwitter ionic buffers where enzymes, biochemicals and co-factors exhibit consistent and stable performance. Quality of water is of utmost importance as it is over 90% in most of the reagents. The water used for manufacturing goes through 5-step purification process to obtain highest purity and lowest contaminants. Only 25% water is recovered after such tough process which qualifies for our use. We only use AR grade (highest purity) chemicals from the most reputed manufacturers.

Formulations

\tOur formulations have a very high conformation to international bodies likeThe International Federation of Clinical Chemistry (IFCC), German Society for Clinical Chemistry (GSCC or DGKC) and The Scandinavian Committee on Enzymes (SCE) making our products acceptable to international standards.

QA and QC protocols

\tGlobal quality is our philosophy. We have developed our internal QC specifications which not only checks the quantities of components in the reagent systems but also checks their functional performance and characteristics, which is unique to us. We also check other parameters of the reagent systems such as pH, blank of the reagent, shelf life study at different temperatures, accelerated stability study, etc. Every batch of products manufactured get tested against 4 independent third-party controls of normal as well as pathological range. Only upon satisfactory performance, the product is released into the market. In addition to this, we participate in various External Quality Assurance Services (EQAS) programs by national and international bodies.

Packaging materials

\tWe employ packaging materials from reputable sources through strict vendor and material specification criteria. All of our plastic and glass materials are made from virgin raw materials. Stringent 4-step washing procedure makes our materials inert and leach-proof. We also have strict leakage and breakage tests to ensure the packaging material does not compromise on our reagent quality. In few cases, we have developed customized packaging materials as per customer demands to ensure temperature stability and protection for long-distance transports.

Production environment

\t All the products are manufactured under controlled environment such as particle-free zones, low humidity chambers and low total microbial counts. Our high-end sophisticated equipments are well maintained and well calibrated to ensure precise specifications of volumes and purity. Finished products or goods in process are stored only in virgin plastic containers having desirable specifications. Regular disinfections of manufacturing rooms and equipment are employed to ensure minimum breakdowns. We also have multiple check points or Quality-planning tools, such as the chart of operating specifications, which act as platform at various stages of manufacturing processes to ensure best product that meet all the required specifications gets passed as a final product and reduce rejections.

Storage environment

\tOur storage space spans about 700 sq. ft. in area which is has controlled environment of temperature, humidity and light. Proper classification of sub-areas helps to assign and keep the products in designated areas and their easy retrieval.

Shipment partners

\tMultiple shipment partners allows us to ship materials from few grams to tons in weight and size. We have separate shipment partners for multiple geographical territories domestic and abroad that meet our requirements of time of deliveries, transport temperatures, etc. All our shipment partners have efficient web based tracking systems of consignments.

In the end, we believe quality is not a static concept but needs continuous improvements to meet newer demands and challenges offered by changing markets, customers and pathogens and diseases.

We are the original manufacturers of the following products. We have a great experience and understanding of creating our own biological formulas for better quality.

Biochemistry Reagents
Urine Strips
Latex and Turbidimetry
Rapid Test Kits
Laboratory Reagents
Laboratory Detergents
Controls and Calibrators
Innovative Products according to the customer requirements