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Lepzi - Testing Made Easy The LEPZI assay platform enables fast flow of diagnostic information for improved medical care..

Our Mission We foster innovation in the field of medical diagnostics by facilitating technological advancements in cooperation with commercial partners and research institutions around the world..

BG/CA01/MD-0043.

BG/CA01/MD-0041.

BG/CA01/MD-0040.

BG/CAO1/MD-OO42.

Lepzi Lepzi Quanti HCG Test O Diagnosis of early pregnancy and embryo development testin 0 Auxiliary diagnosis of ectopic pregnancy O Pregnancy residue detection; Application of tumor markers O Diagnosis and follow-up of trophoblastic disease Rapid Accurate Convenient HCG 300C BG/CA01/MD-0056 (reiQ Lepzi Diagnostika Ltd., Ill-A "Tsarigradsko shose" blvd, Sofia, Bulgaria, 1784. Tel. +359-897-289-089 Ileru.AL,1 AnarHocT1,1Ka EOOA, 6yn. UapnrpaacK0 UJOCe NQ Ill-A, CocbMR, 6bnrapM9, 1784. Ten. +359-897-289-089.

HCG Test Quanti Early pregnancy test Used with colloidal gold analyzer Human chorionic gonadotropin (hCG) is a glycoprotein secreted by trophoblast cells of the placenta. In mature women, a large amount of hCG is produced by placental trophoblast cells after the fertilized ovum moves to the uterine cavity for implantation and forms an embryo. In the process of development and growth into a fetus, it can be excreted into urine through the blood circulation of pregnant women. Human chorionic gonadotropin is secreted 10-14 days after conception. Serum and urine hCG levels rise rapidly at 1-2.5 weeks of gestation, peaking at 8 weeks of gestation and dropping to moderate levels at4 months of gestation, which remain at the end of gestation. Early morning urine hCG levels are highest, close to serum levels, so early Applicable Department Obstetrics and Gynecology (General Hospital I Maternal and Child Health Hospital I Specialist Hospital) Early pregnancy diagnosis Embryo development monitoring I Ectopic pregnancy diagnosis I Trophoblastic disease diagnosis and follow-up I Endocrine disease diagnosis Reproductive Center Early pregnancy diagnosis I Personalized treatment plan prediction Judgment of IVF outcome Cancer center Diagnosis and follow-up of choriocarcinoma I Treatment monitoring of female ovarian blastoma I Male testicular tumors I Other malignant tumors Physical examination centerlThe community clinic Early pregnancy diagnosis I Threatened abortion and postpartum abnormal monitoring I Auxiliary diagnosis of ectopic pregnancy Add sample to 1 HCG test device morning urine is the best test. m I WmL 0.2-lweeks Prod uct Performa nce 1-2w e e ks Gestational weeks 2weeks later Results displayed and printed 0210 Insert HCG test device into the analyzer O Positive threshold: 25mIU/mL Intra-batch precision: Inter-batch precision: CV<200/o O Test range: 10-5000mIU/mL O Test time:10min References : Ill Birken S. Kovalevskaya G. O'Con J. Of hCG and hLH to m ultip-le urinary MOI Cell EndocrinoL 1996 Dec 20; 12511-21:121-31_ 12JfEhnerSF. Timpe F M. Urinary-based ovulation and pregnancy: point-of-rare testing. Ann Pharmacother 21114.

Lepzi Lepzi Quanti Test Normal ovulation was diagnosed J Follicles are flavin or not Mature Follicle discharge was detected To assist in the diagnosis of polycystic ovary syndrome Rapid Accurate Convenient 300C BG/CAOI (feiQ Lepzi Diagnostika Ltd., Ill-A "Tsarigradsko shose" blvd, Sofia, Bulgaria, 1784. Tel. +359-897-289-089 nenuvl Amar-HocTv1Ka EOOA, 6yn. UapnrpaacK0 UJoce NQ 111-A, 6bnrapmn, 1784. Ten. +359-897-289-089.

Quanti Ovulation test Test Used with colloidal gold analyzer Luteinizing hormone (LH) acts on mature oocytes and causes ovulation and luteal formation. Once the LH peak appears, it indicates ovulation in 24-36 hours. F e-tility 0 0000000 Applicable Department Obstetrics and Gynaecology (General hospital I Maternal and Child Health hospital I Specialist hospital) Prediction and monitoring of female ovulation I Auxiliary diagnosis of endocrine diseases such as polycystic ovary syndrome (PCOS) and luteinized unruptured follicle syndrome (LUFS) Auxiliary diagnosis of premature ovarian failure Auxiliary diagnosis of hypothalamic amenorrhea and menopausal syndrome I Determination of endometrial biopsy time Reproductive Center Prediction and monitoring of female ovulation I Determination of the best ovum pick up(OPU) time I Development of personalized ovulation induction programl [kvelop apersonalized ovulation promotion program Physical Examination CenterlCommunity Clinic Prediction and monitoring of female ovulation I Determine whether ovulation is normal I Natural contraception Add sample to LH test device Results displayed and days Low L H Most tertile 2 days High LH level Product Performance Positive threshold : 25m I U/m L Intra-batch precision 15%; Inter-batch precision: O Test range: 10-200mlU/mL Test time : 10min Insert LH test device into the analyzer Correlation o' Roche's tested LH in human 0.97" SO 140 2qx» References: n det Eti nin the h we 'ion end Med 1982 eprod SO bused ovu Iztion and printed referenc«d to true Ann Pharmacothe,_ 2004 tracep.

Lepzi Qualitative Test Non-invasive urine test o Screening for urothelial cell lesions Postoperative follow-up for recurrent bladder tumors Rapid Accurate Convenient 20c X 300C BG/CAOI/MD.XXXX Lepzi Diagnostika Ltd., III-A "Tsarigradsko shose" blvd, Sofia, Bulgaria, 1784. Tel. +359-897-289-089 EOOA, 6yn. Uapnrpaacxo tucxe Ne III-A, COC>VIR, 6bnrapv19, 1784. Ten. +359-897-289-089.

BTA Qualitative Test Rapid screening of urinary system epithelial cell High level of complement factor H(BTA) in urine, suggesting the occurrence of urothelial cell pathology Complement factor H (BTA) can be used for rapid screening Early Screening Auc 0.81 urinry cytology AUC 0.83 BTA Auc 0.88 BTA4urinry cytology of urinary epithelial lesions BTA Positive Risk of urothelial Rapid Test cell lesions Negative Low risk of urothelial cell lesions High-risk Groups/Risk Factors Smokers Sedentary population Tumor family history population From Urology Oncology. Faysal A.Yafi. et al. Prospective analysis of sensitivity and specificity of urinary cytology and other urinary biomarkers for bladder cancer, 2015, BTA rapid test combines sensitivity and specificity. B TA testing combined with urine cytology for early screening of bladder tumors can reduce missed diagnosis.Early detection improves prognosis. Recurrence Monitoring Eliminate inflammation and lithiasis,Confirm medical history of urinary system tumors Further exclusion and diagnosis from clinical specialtyspecialty Long-term exposure to industrial chemicals Use medications that affect urinary health Chronic infection of bladder 1 1 1 Postoperative dTA follow-up program for low-risk patients Postoperative bladder tumor Cystoscopy BTAfollow-up B TA test is suitable for being a good supplement for cystoscopy due to its non-invasive, simple and rapid characteristics. Due to the high recurrence rate of bladder tumor, flexible BTA follow-up between cystoscopy can be performed for patients after operation of bladder tumor to timely and effectively monitor the recurrence of bladder tumor. 2 Add 3 drops urine to BTAtest device References : Cell ct P ro 2nd of urinzr,• cytology 2nd urinary biome.

Lepzi Qualitative COVID-19 Qualitative detection of SARS-CoV-2 antigens in human nose and throat 0 Simple Operation 0 High Accuracy 0 Easy Visually Interpretation o No Equipment Required Rapid Accurate Convenient X 300 C BG'CAOI IMD-XXXX Lepzi Diagnostika Ltd., Ill-A "Tsarigradsko shose" blvd, Sofia, Bulgaria, 1784. Tel. +359-897-289-089 flenL4L4 EOOA, 6yn. UapmrpaacK0 woce Ne 111-A, Bbnrapvtq, 1784. Ten. +359-897-289-089.

COVID-19Test Qua Litative Spike glycoprotein (S) Membrane protein Nucleoprotein Genomic RNA Molecular Structure of COVID-19 The Rapid Antigen Test is a qualitative point of care, lateral Flow immunoassay and is used as an aid to the qualitative detection of SARS- COV-2 antigens in human nasal and throat swabs from individuals who are at risk or suspected of COVID-19 by their healthcare provider during the acute phase of infection. Nasal or throat swabs sample collection Add 5 drops of extract to the test device Sample extraction Wait 10 minutes to interpret the results T T c c POSITIVE It the test line (T) is visble, inocates positive SARS-CoV•2 result. If the test line (T) is rant. indEates positive SARS-CoV-2 rßult. NEGATIVE It the tæt (T) is not irücates negative result. INVALID If the cmtrol lire (C) is absent. test is invalid..