Infectious Disease
-
Bacterial vaginosis Test
INTENDED USE The StrongStep® Bacterial vaginosis(BV) Rapid Test Device is intend to measure the vaginal pH for aid in the diagnosis of Bacterial vaginosis. INTRODUCTION An acidic vaginal pH value of 3.8 to 4.5 is a basic requirement for the optimal functioning of the body’s own system of protecting the vagina. This system can effectively avoid colonization by pathogens and the occurrence of vaginal infections. The most important and most natural protection against vaginal probl... -
Candida Albicans
INTRODUCTION Vulvovaginal candidiasis (WC) is thought to be one of the most common causes of vaginal symptoms. Approximately, 75% of women will be diagnosed with Candida at least once during their lifetime. 40-50% of them will suffer recurrent infections and 5% are estimated to develop chronic Candidiasis. Candidiasis is more commonly misdiagnosed than other vaginal infections. Symptoms of WC which include: acute itching, vaginal soreness, irritation, rash on the outer lips of the vagina... -
Chlamydia & Neisseria gonorrhoeae
INTRODUCTION Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral and anal sex. The causative organism can infect the throat, producing a severe sore throat. It can infect the anus and rectum, producing d condition called proctitis. With females, it can infect the vagina, causing irritation with drainage (... -
Chlamydia Antigen
StrongStep® Chlamydia trachomatis rapid test is a rapid lateral-flow immunoassay for the qualitative presumptive detection of Chlamydia trachomatis antigen in male urethral and female cervical swab. Benefits Convenient and fast 15 minutes required, prevention of nervous waiting for the results. Timely treatment The high predictive value for positive result and high specificity decreases the risk of sequelae and further transmission. Easy to use One- procedure, no special skills or instru... -
Cryptococcal Antigen Test
INTENDED USE The StrongStep® Cryptococcal Antigen Rapid Test Device is a rapid immunechromatographic assay for the detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum, plasma, whole blood and cerebral spinal fluid (CSF). The assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis. INTRODUCTION Cryptococcosis is caused by both species of the Cryptococcus species com... -
HSV 12 Antigen Test
INTRODUCTION HSV is an envelop, DNA-comtaining virus morphologically similar to the other members of the genus Herpesviridae.Two antigenically distinct types are recognized, designated type 1 and type 2. HSV type 1 and 2 are frequently implicated in superficial infections of the oral cavity, the skin, the eye and the genitalia, Infections of the central nervous system (meningoencephalitis)and severe generalized infection in the neonate of immunocompromised patient are also seen, though mo... -
Neisseria gonorrhoeae
The StrongStep® Neisseria gonorrhoeae Antigen rapid test is a rapid lateral-flow immunoassay for the qualitative presumptive detection of Neisseria gonorrhoeae antigen in male urethral and female cervical swab. Benefits Accurate High sensitivity(97.5%) and high specificity(97.4%) according to the results of 1086 cases of clinical trials. Rapid Only 15 minutes required. User-friendly One-step procedure to detect the antigen directly. Equipment-free The source-limiting hospitals or clinica... -
Screening Test for Cervical Pre-cancer and Cancer
INTENDED USE The StrongStep® HPV 16/18 Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative presumptive detection of HPV 16/18 E6&E7 oncoproteins in female cervical swab specimens. This kit is intended to be used as an aid in the diagnosis of Cervical Pre-cancer and Cancer. INTRODUCTION In developing countries, cervical cancer is a leading cause of cancer related death of women, due to the lack of implementation of screening tests for cervical pre-cancer and ca... -
Strep A Rapid Test
INTENDED USE The StrongStep® Strep A Rapid Test Device is a rapid immunoassay for the qualitative detection of Group A Streptococcal (Group A Strep) antigen from throat swab specimens as an aid to the diagnosis of Group A Strep pharyngitis or for culture confirmation. INTRODUCTION Beta-haemolytic Group B Streptococcus is a major cause of upper respiratory infections in humans. The most commonly occurring Group A Streptococcal disease is pharyngitis. The symptoms of this, if left untreate... -
Strep B Antigen Test
StrongStep® Strep B antigen Rapid Test is a rapid visual immunoassay for the qualitative presumptive detection of Group B Streptococcal antigen in female vaginal swab. Benefits Rapid Less than 20 minutes needed for the results. Non-invasive Both vaginal and cervical swab is OK. Flexibility No special instruments required. Storage Room temperature Specifications Sensitivity 87.3% Specificity 99.4% Accuracy 97.5% CE marked Kit Size=20 kits File: Manuals/MSDS ... -
Trichomonas vaginalis
INTENDED USE StrongStep® Trichomonas Vaginalis Antigen Rapid Test is intended for the qualitative detection of Trichomonas vaginalis (*Trichomonasw) antigens from vaginal swabs. This kit is intended to be used as an aid in the diagnosis of Trichomonas infection. INTRODUCTION Trichomonas infection is responsible for the most common, non-viral sexually transmitted disease (vaginitis or trichomoniasis) worldwide. Trichomoniasis is a significant cause of morbidity among all infected patients... -
Trichomonas vaginalis &Candida
The StrongStep® StrongStep® Trichomonas/ Candida rapid test Combo is a rapid lateral-flow immunoassay for the qualitative presumptive detection of trichomonas vaginalis /candida albicans antigens from vaginal swab. Benefits Fast Only 10 minutes required. Save time and cost One test for two diseases with single swab. Simultaneous detection Differentiate the two diseaes distinctly. User-friendly Easily performed and interpreted by all health care personnels. Room temperature storage Specif...
