Am I Rapid hCG Pregnancy Test Device (Biotron — WHO-GMP)
Pack Sizes Available
Product Description
Technical Specifications
- Brand / Manufacturer: am i Rapid — Biotron brand; manufactured to WHO-GMP standards; CDSCO registered IVD diagnostic device (India); hCG rapid test device format (cassette)
- Test Method and Target: One-step lateral flow chromatographic immunoassay; qualitative detection of human chorionic gonadotropin (hCG) in urine using monoclonal anti-hCG antibody conjugate; anti-hCG antibody coated on test membrane
- Sensitivity and Specificity: Sensitivity: 25 mIU/mL (WHO International Standard calibrated); Specificity: >99%; no cross-reactivity with LH (300 mIU/mL), FSH (1,000 mIU/mL), TSH (1,000 μIU/mL); detects hCG from 7–10 days post-conception
- Sample and Procedure: Sample: urine (first morning preferred); add 3–4 drops (~100–120μL) via included disposable pipette to specimen well; read result at 3–5 minutes; do not read after 10 minutes; two lines (C+T) = positive, C only = negative, no C = invalid
- Storage and Shelf Life: Store at 2–30°C ambient; no refrigeration required; no cold chain required in distribution; shelf life: 24 months from manufacture; individually foil-sealed with desiccant; bring to room temperature before use
Frequently asked questions
The am i Rapid hCG Device detects human chorionic gonadotropin (hCG) — the hormone produced by the developing placenta after fertilisation — in urine. The test has a sensitivity threshold of 25 mIU/mL, which is the standard clinical cutoff for early pregnancy detection. hCG first appears in urine approximately 7 to 10 days after conception and rises rapidly, typically exceeding 50 mIU/mL by the day of the first missed menstrual period. This means the test can reliably detect pregnancy from the first day of the missed period in most women, with some cases detectable even slightly before, depending on individual hCG rise rates.
WHO-GMP (World Health Organization Good Manufacturing Practices) certification on the am i Rapid device indicates that the manufacturing facility produces the test under quality management conditions that meet WHO-defined standards for pharmaceutical and diagnostic product manufacturing. This includes validated manufacturing processes, documented quality controls, proper environmental monitoring, batch testing, and traceability from raw material to finished product. WHO-GMP certification is increasingly required as a procurement condition by government health ministries, international aid organisations (UNICEF, UNFPA, Global Fund), and public health programme procurement authorities in Africa, the Middle East, and South and Southeast Asia.
The procedure is three steps. First, collect a urine sample — first morning urine is preferred for maximum hCG concentration, but the test can be used at any time of day. Second, using the pipette provided in the kit, dispense 3 to 4 drops (approximately 100–120μL) of urine into the specimen well of the cassette. Third, read the result between 3 and 5 minutes. Two coloured lines — one in the control region (C) and one in the test region (T) — indicates a positive result (pregnancy detected). One coloured line in the C region only indicates negative (not pregnant). No coloured line in the C region, regardless of what appears in T, indicates an invalid test — repeat with a new device.
False positives can occur in specific clinical situations: trophoblastic disease (hydatidiform mole, choriocarcinoma), certain non-trophoblastic neoplasms including germ cell tumours, and in patients receiving hCG-containing medications such as Pregnyl, Profasi, Pergonal, or APL for infertility treatment. Common substances including oral contraceptives, antibiotics, painkillers, and hormone therapies that do not contain hCG do not interfere with the test. False negatives can occur when urine is very dilute (low specific gravity), when the test is performed too early before hCG has risen above 25 mIU/mL, or technically when the result is read after 10 minutes. If pregnancy is still suspected after a negative result, a first morning urine specimen should be collected 48 hours later and retested.
The am i Rapid hCG Device is stored at ambient temperature — 2 to 30°C — throughout its shelf life of 24 months from the date of manufacture. No refrigeration is required at any stage from manufacture through distribution to end use. Devices should be protected from direct sunlight, humidity, and extreme heat. Individual devices are sealed in foil pouches with desiccant and should remain in the sealed pouch until immediately before use. The device must be brought to room temperature (15–30°C) before opening the pouch if it has been stored at the lower end of the temperature range.
The am i Rapid hCG Device is available in a standard institutional box of 25 tests and an alternate hospital format of 40 tests per box. A single test per foil pouch format is also available for OTC retail and field distribution programmes. Each individually pouched device includes the test cassette and a disposable pipette. For wholesale and export procurement, Sara Wellness supplies both box formats and can accommodate carton-quantity orders. Orders can be combined across multiple rapid test SKUs from Biotron and other WHO-GMP certified manufacturers within a single export shipment.
Microlisa HIV Ag & Ab 4th Generation ELISA Test Kit
Blood screening exists in a category of laboratory work where the margin for error is not just professionally unacceptable but medically catastrophic. A false negative in HIV screening does not just fail a test. It compromises patient safety, undermines transfusion protocols, and exposes healthcare systems to risks that nobody wants to calculate. Microlisa HIV Ag & Ab 4th Generation ELISA was engineered to close the detection window that makes early HIV infection so difficult to identify reliably. This is an in-vitro qualitative enzyme immunoassay designed for simultaneous detection of antibodies to HIV-1 (including Group O and subtype C prevalent in India), HIV-2, and HIV-1 p24 antigen in human serum or plasma. The test is intended for screening of blood donors, diagnostic testing of individuals at risk for HIV infection, and clinical evaluation of patients with AIDS-related symptoms. It represents the fourth generation of HIV ELISA technology, which detects both antibodies and antigens simultaneously rather than antibodies alone. The clinical advantage of 4th generation testing is the shortened window period. Traditional antibody-only tests miss early seroconversion cases where HIV-1 p24 antigen is present but antibodies have not yet developed to detectable levels. By detecting p24 antigen during the acute infection phase (typically 2 to 4 weeks post-exposure), this assay identifies infections approximately 1 to 2 weeks earlier than 3rd generation antibody-only tests. That earlier detection matters critically in blood donor screening and post-exposure monitoring. The assay is based on sandwich ELISA methodology. Microtiter wells are pre-coated with HIV envelope proteins (gp41, C-terminus of gp120 for HIV-1, and gp36 for HIV-2) and anti-p24 monoclonal antibodies. When specimens are added, any HIV antibodies or p24 antigen present bind to the coated antigens or antibodies. After washing, horseradish peroxidase (HRPO) conjugated antigens and anti-p24 antibodies are added, forming a sandwich complex. The colorimetric reaction develops proportionally to the amount of HIV antibodies or antigen present, read at 450nm absorbance. The kit uses color-coded reagents to monitor procedural steps, reducing protocol errors during multi-step workflows. Breakaway microwell strips allow testing flexibility from single specimens to full 96-well plate runs. Storage stability is maintained at 2-8°C with a shelf life of 24 months unopened. Total assay time including incubation steps is approximately 120 minutes. Sensitivity and specificity meet international standards for 4th generation HIV screening. Clinical evaluations demonstrate 100% sensitivity in detecting seroconversion panels and p24 antigen standards quantified down to 200 pg/ml. Specificity exceeds 99.5% when tested against large sample populations. The test detects all major HIV-1 subtypes including Group O and subtype C, which are epidemiologically significant in the Indian subcontinent. For distributors supplying blood banks, transfusion centers, diagnostic laboratories, and public health screening programs, Microlisa HIV Ag & Ab represents a clinically validated 4th generation screening platform with predictable reorder cycles. Sara Wellness has been exporting in-vitro diagnostic kits and laboratory reagents from India for 15 years.
Advantage PAN Malaria Card Rapid Diagnostic Test Kit
Malaria diagnosis in endemic regions operates under time pressure that microscopy cannot always accommodate. A patient presenting with fever in a rural health center at midnight does not have the luxury of waiting until morning for a trained microscopist to arrive, prepare slides, and spend twenty minutes examining blood films under oil immersion. That delay can mean the difference between timely artemisinin treatment and cerebral malaria developing overnight. Advantage PAN Malaria Card was designed to deliver species-level diagnosis in settings where microscopy is impractical or unavailable. This is a rapid visual immunoassay for qualitative detection of all four human Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) based on pan-specific plasmodium lactate dehydrogenase (pLDH) antigen in whole blood. The test provides results within 20 minutes using a simple fingerstick blood sample, no laboratory equipment required, making it ideal for point-of-care testing in primary health centers, rural clinics, field hospitals, and outbreak response settings. The assay is based on sandwich immunochromatography using monoclonal antibodies specific to pLDH, an enzyme produced by all Plasmodium species during their erythrocytic life cycle. When infected blood is added to the test device and assay buffer is applied, red blood cells lyse and pLDH antigen (if present) binds to gold-conjugated anti-pLDH antibodies. This complex migrates along the nitrocellulose membrane and is captured by immobilized anti-pLDH antibodies at the test line, producing a visible pink-purple band that confirms malaria infection. The see-through device design allows direct visualization of sample migration and result development, which helps identify invalid tests caused by insufficient sample volume or improper application. This transparency reduces the ambiguity that plagues some lateral flow devices where internal workings are hidden. Sensitivity and specificity have been validated through WHO malaria RDT evaluation programs using panels of wild and cultured parasites. The test detects parasitemia levels above 100 parasites per microliter of blood for both P. falciparum and P. vivax, which is clinically relevant for symptomatic infections requiring treatment. Specificity exceeds 99% when tested against cross-reactive conditions including dengue, leptospirosis, typhoid, and other febrile illnesses common in malaria-endemic areas. Shelf life is 24 to 30 months when stored at 4-30°C, which is critical for stockpiling in tropical climates where cold chain infrastructure is unreliable. The extended temperature stability means the test remains functional even when stored at ambient temperatures in resource-limited settings. Each kit contains individually sealed test devices, buffer vials, blood collection pipettes, and instructions for use. The test requires no special training beyond basic clinical skills and can be performed by nurses, paramedics, or trained community health workers. For distributors supplying national malaria control programs, public health departments, NGO field operations, and private diagnostic laboratories, Advantage PAN Malaria Card represents a WHO-evaluated rapid diagnostic platform with predictable consumption tied to malaria case loads. Sara Wellness has been exporting rapid diagnostic test kits and laboratory reagents from India for 15 years.
Human Serum Coombs Antisera (Antihuman Globulin Reagent)
Blood banking operates on a fundamental requirement that most people never think about until something goes wrong. Every unit of blood transfused must be confirmed compatible with the recipient's immune system. Every pregnant woman screened for antibodies that could harm her unborn child. Every suspected case of hemolytic anemia investigated for antibodies attacking the patient's own red blood cells. None of this happens without Coombs antisera making the invisible antibodies visible. Human Serum Coombs Antisera is the reagent that makes antiglobulin testing possible in blood banks and immunohematology laboratories worldwide. This is antihuman globulin (AHG) reagent used in both direct and indirect antiglobulin tests (Coombs tests) to detect antibodies and complement components bound to red blood cell surfaces or present free in serum. The reagent is produced by immunizing animals (typically rabbits) with human immunoglobulins, which induces production of polyclonal antibodies specific for human IgG antibodies and complement factor C3d. When added to washed red blood cells coated with IgG or complement, the antihuman antibodies bind to the human antibodies and form bridges between adjacent sensitized cells, causing visible agglutination. The direct antiglobulin test (DAT) detects antibodies or complement already bound to red blood cell surfaces in vivo. This test is critical for diagnosing autoimmune hemolytic anemia, investigating hemolytic transfusion reactions, and diagnosing hemolytic disease of the fetus and newborn. The indirect antiglobulin test (IAT) detects free antibodies circulating in serum or plasma. This test is essential for pre-transfusion antibody screening, crossmatching blood units for compatibility, and prenatal antibody screening in pregnant women. Polyspecific Coombs antisera (like the green-colored reagent shown) contains antibodies against both IgG and C3d complement, providing broad-spectrum detection. When the polyspecific reagent produces a positive result, monospecific antisera (anti-IgG alone or anti-C3d alone) are used for follow-up testing to characterize whether red cells are coated with IgG antibodies, complement, or both. This differentiation is clinically important because it helps determine the cause and clinical significance of the positive test. The reagent is typically dyed green using patent blue and tartrazine to allow easy visual identification during laboratory workflows where multiple reagents are used simultaneously. Storage at 2-8°C maintains reagent potency until the expiration date printed on the bottle, typically 18 to 24 months from manufacture. The reagent contains sodium azide (0.1% w/v) as a preservative, which inhibits bacterial growth but requires careful handling and disposal. Each dropper bottle delivers approximately 40 microliters per drop, allowing precise volumetric dosing during testing. The reagent must not be diluted and should not be used if turbid, as turbidity indicates bacterial contamination or protein aggregation that will compromise test performance. For distributors supplying blood banks, hospital transfusion services, reference immunohematology laboratories, and donor screening centers, Coombs antisera represents an essential reagent with consumption directly tied to transfusion volume and prenatal screening programs. Sara Wellness has been exporting immunohematology reagents and blood banking supplies from India for 15 years.