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FEASIBILITY REPORT & PROPOSAL 1 FOR NACO
Prepared By : SANDOR MEDICAIDS 04/03/09
2
Overview of talk • Global epidemiology of STIs/RTIs • Population-based prevalence of RTIs • Sequelae of STIs • TV & Bacterial vaginosis in pregnancy • Syphilis in pregnancy • HIV in pregnancy • Options for prevention and care
04/03/09
3
04/03/09
4
04/03/09
What are the complications and sequelae5 of RTIs? In adults In children • Pelvic inflammatory disease (PID) • Stillbirths • Ectopic pregnancy • Prematurity, low birth weight • Spontaneous abortions • Congenital syphilis • Post-partum infections • Conjunctivitis and blindness • Infertility (male & female) • Pneumonia • Cancers (cervical, anal, penile, liver) • Increased HIV transmission
04/03/09
Trichomoniasis 6
• Caused by Trichomonas vaginalis • Is usually sexually transmitted • Incubation period 3-28 days • Affects women more than men • Presents with a vaginal discharge – Scanty to profuse, usually yellow-green tinted – can be atypical depending on host factors
04/03/09
7
Trichomoniasis • Can present with vulval erythema, oedema and excoriations • Cervix may be involved – "strawberry cervix" • Asymptomatic in 50% of cases • Accounts for 15-20% of cases of vaginitis • Associated with a 2-6 fold increase in risk of HIV transmission*
*Van Der Pol et al. JID 2008, 197:548–54
04/03/09
8
Trichomonas vaginalis and Pregnancy • Associated with low birth weight • Preterm delivery • Preterm delivery of low birth weight baby • Perinatal transmission – only with female offspring in about 5% of cases − May present with Vg discharge in infant − Usually self-limiting in the infant (3-4 weeks)
04/03/09
Bacterial 9vaginosis • A clinical polymicrobial syndrome characterized by: − an increase in gram-negative anaerobic bacteria (Gardnerella vaginalis, Mobiluncus spp, Prevotella spp, Bacteroides, Peptostreptococcus, Fusobacterium, Porphyromonas, Mycoplasma hominis, etc.) − a reduction in the concentration of Lactobacilli • It is the most common cause of abnormal vaginal discharge in women of reproductive age − asymptomatic in about 50% of women
04/03/09
Trichomonas vaginalis and Pregnancy 10
• Associated with low birth weight • Preterm delivery • Preterm delivery of low birth weight baby • Perinatal transmission – only with female offspring in about 5% of cases − May present with Vg discharge in infant − Usually self-limiting in the infant (3-4 weeks)
04/03/09
Bacterial vaginosis 11
Cervix covered with a discharge associated with BV − white to grey, homogeneous (nonflocullar), − thin and adherent
04/03/09
12
04/03/09
13
Normal flora: Gram-stained smear showing a pure flora of Gram-positive rods of lactobacilli Gram-stained smear showing mixed intermediate flora - Grampositive and Gram-negative organisms
04/03/09
Diagnosis of Bacterial Vaginosis 14 Clinical criteria
Amsel's criteria (3 of 4) • Homogeneous thin vaginal discharge • Vaginal pH > 4.5 • “Fishy” odour upon contact of the sample with KOH 10% (positive whiff test) • Epithelial cells covered with bacteria (Clue cells)
Amsel R, 1983 Am J of Medicine, 74:14
04/03/09
Diagnosis of Bacterial Vaginosis 15 Clinical criteria Nugent's criteria- assigns a score of 0-10 based on different bacterial morphotypes seen in the stained smear. A score of: 0-3 Normal 4-6 intermediate 7-10 is consistent with bacterial vaginosis • Good intra-observer agreement • High reproducibility • Sensitivity of 85-90% • Specificity of more than 90%
04/03/09
16
04/03/09
17 Bacterial vaginosis and pregnancy
Evidence of an association between BV • first trimester miscarriage • mid-trimester (16-20 wk) abortion • preterm birth - specifically preterm delivery < 30 wk that results in births of newborns < 1000 g • Preterm rupture of membranes • chorioamnionitis • Postpartum endometritis • Post-abortion infections • Post-procedural infections
Kurki T 1992 Obstet Gynecol 80: 173, Meis P 1995 Am J Obstet Gynecol 173:1231 Hillier S 1988 N Engl J Med 319: 972
04/03/09
Bacterial vaginosis and pregnancy 18
It has been speculated that BV • facilitates access of bacteria into the amniotic cavity • remains in the uterine cavity as a chronic infection
Kurki T 1992 Obstet Gynecol 80: 173, Meis P 1995 Am J Obstet Gynecol 173:1231 Hillier S 1988 N Engl J Med 319: 972 04/03/09
Managing asymptomatic BV infection in pregnant women 19
Some studies show that treatment of pregnant women with BV, who have a history of preterm delivery (high risk), might reduce the risk for prematurity •Screening and treating in pregnancy − might be beneficial for asymptomatic, high risk women − should be conducted at the earliest part of the 2nd trimester to be of benefit
04/03/09
20
04/03/09
BV and HIV 21
Evidence that BV and HIV are related • Theoretical basis • Epidemiological observations • Therapeutic intervention studies
04/03/09
Theoretical 22 basis BV characterised by: – absence of Lactobacilli – low H2O2 – high pH Conditions believed to be conducive to increased susceptibility to HIV infection
04/03/09
Table 2. Mechanisms by which gynecologic 23 infections enhance transmission of human immunodeficiency virus. Loss of protective H2O2-positive lactobacilli Disruption of normal epithelial barrier (portal of entry) Recruitment of susceptible cells Stimulation of susceptible cells Enhanced HIV replication Lesions and/or disease are a source or point of infection of HIV
04/03/09
Epidemiological Observations 24
Epidemiological association found in cross-sectional and prospective studies • Relationship is dose-dependent – severe BV is associated with increasing risk of HIV infection – relative risk of HIV acquisition = 2 to 4
Cohen et al. AIDS 1995; Sewankambo et al. Lancet 1997; Taha et al. AIDS 1998; Martin et al. JID 1999.
04/03/09
Association between BV and HIV acquisition? 25 • 4718 women 15-59 years • Nugent criteria for diagnosis of BV HIV: 14.2 % in women with normal flora 26.7 % in women with severe BV (Nugent 9-10)p < 0.001
Community study in Rakai, Uganda Sewankambo, N Lancet 1997 350: 546a
04/03/09
Table I: Distribution as per Laboratory Diagnosis 26
Department of Community Medicine, M.K.C.G. Medical College, Brahmapur
04/03/09
Table II: Distribution as per Clinical diagnosis
27
Department of Community Medicine, M.K.C.G. Medical College, Brahmapur
04/03/09
Table III --Prevalence of various RTIs among married (non-pregnant) women aged 16– 22 in 13 villages in Vellore District of Tamil Nadu, south India (N = 451).
28
04/03/09
Table 2. Possible factors affecting prevalence of RTIs in young women
29
04/03/09
30
Reference: Gynaecological problems among young married women in Tamil Nadu, India Abraham Joseph, Jasmin Prasad and Sulochana Abraham
04/03/09
Vaginal and iatrogenic infections 31
Vaginal infections • are most common cause of RTIs in women • are associated with adverse outcomes of pregnancy • are associated with increased susceptibility to HIV infection • are associated with high health-care costs to individual women and to health-care system • due to iatrogenic infections, contribute heavily to burden of maternal morbidity and mortality (true magnitude unknown)
04/03/09
32
04/03/09
33
Prevalence of bacterial vaginosis among women in Delhi, India P. Bhalla, Rohit Chawla, S. Garg*, M.M. Singh*, U. Raina**, Ruchira Bhalla & Pushpa Sodhani† Departments of Microbiology, *Community Medicine, **Obstetrics & Gynaecology Maulana Azad Medical College & associated LN Hospital, New Delhi &
04/03/09
Background & objectives:34Bacterial vaginosis is the most common cause of vaginal discharge among women in reproductive age. Surveillance studies on bacterial vaginosis are mostly based on specialist clinic settings. As few population-based prevalence surveys of bacterial vaginosis have been conducted, we studied the prevalence of bacterial vaginosis in the urban and rural communities in Delhi, and to associate the presence of bacterial vaginosis with demoraphic profile, risk factors and presence of other reproductive tract infections (RTIs)/ sexually
04/03/09
35
Results: Bacterial vaginosis was diagnosed in 70 (32.8%) subjects. A high percentage though asymptomatic (31.2%) were found to have bacterial vaginosis. Highest prevalence was seen in urban slum (38.6%) followed by rural (28.8%) and urban middle class community (25.4%). All women with vaginal trichomoniasis were found to have bacterial vaginosis while 50 per cent of subjects having syphilis also had bacterial
04/03/09
36
Interpretation & conclusion: The study showed high prevalence of bacterial vaginosis. The asymptomatic women having bacterial vaginosis are less likely to seek treatment for the morbidity and thus are more likely to acquire other STIs. Women attending various healthcare facilities should be screened and treated for bacterial vaginosis to reduce the risk of
04/03/09
The maturation of the acquired immunodeficiency syndrome epidemic has now claimed 37 worldwide, the majority in more than 12 million women undeveloped countries where human immunodeficiency virus (HIV) and sexually transmitted infections coexist and interact synergistically. Among HIV-infected women, there is excessive morbidity due to sexually transmitted diseases (STDs) and gynecologic disorders. This review summarizes the expanding understanding of vaginal flora, vaginitis, cervicitis, pelvic inflammatory disease, and genital ulcer disease in HIV-infected women. In addition to the altered clinical course, complications, and management difficulties of STDs, some gynecologic infections may influence HIV transmission as well as the vertical transmission of HIV to the newborn. Finally, severe immunodeficiency allows unusual opportunistic pathogens to invade the upper and lower genital tract. Control and prevention of gynecologic infections in HIVpositive and HIV-negative women are key components to preventing further HIV transmission. 04/03/09
38
NACO AND ITS ROLE TO FIGHT AGAINST AIDS/HIV
04/03/09
39
04/03/09
40
04/03/09
41
04/03/09
42
STRATEGIC MOVE : PUBLIC PRIVATE PARTNERSHIP: *.TO EXPAND DELIVERY OF PPTCT *.PARTNERSHIP WITH FOGSY TO COVER 10 MILLION PREGNANT WOMEN ON ACTUAL COST BASIS
04/03/09
43
No of Estimated pregnancy in India: 27 million No. of HIV Infected Mothers: 1,89,000 No. of Infected Babies : 56,700 (Vertical Transmission of Infection.)
04/03/09
COVERAGE OF NACO
44
NO OF MEDICAL COLLEGES : > 200 NO OF DISTRICT HOSPITALS: > 500 AVG. PATIENT OPD IN MOTHER AND CHILD CARE : 200 PATIENTS/WEEK CHILD BEARING CASES (20% OF TOTAL) : 40 CASES/WEEK 1ST TRIMESTER OR 28-31 WEEK PREGNANCY: 50% 20 CASES/WEEK
04/03/09
PER YEAR PER HOSPITAL : N45x 4 x 12 N=20 FOR MEDICAL COLLEGE N1=10 FOR DISTRICT HOSPITAL NO OF CASES PER MEDICAL COLLEGE PER YEAR= 960 TOTAL NO OF CASES IN MEDICAL COLLEGES: 960 X 200 = 192000 CASES PER YEAR NO OF CASES PER DISTRICT HOSPITAL PER YEAR = 480 TOTAL NO OF CASES IN DISTRICT HOSPITALS: 480 X 500 = 240000
04/03/09
46
TOTAL NO OF CASES TO BE COVERED TOTAL NO OF CASES IN MED COL. + TOTAL NO OF CASES IN DIST. HOSP 1920000 + 240000 = 4320000 CASES TO BE DIAGNOSED FOR BACTERIAL VAGINOSIS : 432000 CASES TO BE DIAGNOSED FOR TRICHOMONIASIS : 432000
04/03/09
47
RATES: BV BLUE : 250/- PER TEST T V TEST: 325/- PER TEST
04/03/09
48
TOTAL COST INCUR FOR BV BLUE : 11 CRORE TOTAL COST INCUR FOR TV TEST : 14 CRORE TOTAL PROJECT COST : 25 CRORE
04/03/09
49
04/03/09
50
BV BLUE TEST
TRICHOMONAS RAPID TEST
1. Rapid test : conducted in 10
1. . Rapid test : conducted in 10
minutes. 2. High Sensitivity and Specificity with more than 95% NPV and PPV 3.As accurate as gram staining and smear US FDA approved Cost effective and convinient to use
minutes. Dipistick method-single reagent. 2. 83% sensitivity vs. culture and 95% agreement against composite reference 3. US FDA approved 4. Cost effective and convinient to use
04/03/09
51
04/03/09
52
04/03/09
53
04/03/09
Prepared By : SANDOR MEDICAIDS 04/03/09
2
Overview of talk • Global epidemiology of STIs/RTIs • Population-based prevalence of RTIs • Sequelae of STIs • TV & Bacterial vaginosis in pregnancy • Syphilis in pregnancy • HIV in pregnancy • Options for prevention and care
04/03/09
3
04/03/09
4
04/03/09
What are the complications and sequelae5 of RTIs? In adults In children • Pelvic inflammatory disease (PID) • Stillbirths • Ectopic pregnancy • Prematurity, low birth weight • Spontaneous abortions • Congenital syphilis • Post-partum infections • Conjunctivitis and blindness • Infertility (male & female) • Pneumonia • Cancers (cervical, anal, penile, liver) • Increased HIV transmission
04/03/09
Trichomoniasis 6
• Caused by Trichomonas vaginalis • Is usually sexually transmitted • Incubation period 3-28 days • Affects women more than men • Presents with a vaginal discharge – Scanty to profuse, usually yellow-green tinted – can be atypical depending on host factors
04/03/09
7
Trichomoniasis • Can present with vulval erythema, oedema and excoriations • Cervix may be involved – "strawberry cervix" • Asymptomatic in 50% of cases • Accounts for 15-20% of cases of vaginitis • Associated with a 2-6 fold increase in risk of HIV transmission*
*Van Der Pol et al. JID 2008, 197:548–54
04/03/09
8
Trichomonas vaginalis and Pregnancy • Associated with low birth weight • Preterm delivery • Preterm delivery of low birth weight baby • Perinatal transmission – only with female offspring in about 5% of cases − May present with Vg discharge in infant − Usually self-limiting in the infant (3-4 weeks)
04/03/09
Bacterial 9vaginosis • A clinical polymicrobial syndrome characterized by: − an increase in gram-negative anaerobic bacteria (Gardnerella vaginalis, Mobiluncus spp, Prevotella spp, Bacteroides, Peptostreptococcus, Fusobacterium, Porphyromonas, Mycoplasma hominis, etc.) − a reduction in the concentration of Lactobacilli • It is the most common cause of abnormal vaginal discharge in women of reproductive age − asymptomatic in about 50% of women
04/03/09
Trichomonas vaginalis and Pregnancy 10
• Associated with low birth weight • Preterm delivery • Preterm delivery of low birth weight baby • Perinatal transmission – only with female offspring in about 5% of cases − May present with Vg discharge in infant − Usually self-limiting in the infant (3-4 weeks)
04/03/09
Bacterial vaginosis 11
Cervix covered with a discharge associated with BV − white to grey, homogeneous (nonflocullar), − thin and adherent
04/03/09
12
04/03/09
13
Normal flora: Gram-stained smear showing a pure flora of Gram-positive rods of lactobacilli Gram-stained smear showing mixed intermediate flora - Grampositive and Gram-negative organisms
04/03/09
Diagnosis of Bacterial Vaginosis 14 Clinical criteria
Amsel's criteria (3 of 4) • Homogeneous thin vaginal discharge • Vaginal pH > 4.5 • “Fishy” odour upon contact of the sample with KOH 10% (positive whiff test) • Epithelial cells covered with bacteria (Clue cells)
Amsel R, 1983 Am J of Medicine, 74:14
04/03/09
Diagnosis of Bacterial Vaginosis 15 Clinical criteria Nugent's criteria- assigns a score of 0-10 based on different bacterial morphotypes seen in the stained smear. A score of: 0-3 Normal 4-6 intermediate 7-10 is consistent with bacterial vaginosis • Good intra-observer agreement • High reproducibility • Sensitivity of 85-90% • Specificity of more than 90%
04/03/09
16
04/03/09
17 Bacterial vaginosis and pregnancy
Evidence of an association between BV • first trimester miscarriage • mid-trimester (16-20 wk) abortion • preterm birth - specifically preterm delivery < 30 wk that results in births of newborns < 1000 g • Preterm rupture of membranes • chorioamnionitis • Postpartum endometritis • Post-abortion infections • Post-procedural infections
Kurki T 1992 Obstet Gynecol 80: 173, Meis P 1995 Am J Obstet Gynecol 173:1231 Hillier S 1988 N Engl J Med 319: 972
04/03/09
Bacterial vaginosis and pregnancy 18
It has been speculated that BV • facilitates access of bacteria into the amniotic cavity • remains in the uterine cavity as a chronic infection
Kurki T 1992 Obstet Gynecol 80: 173, Meis P 1995 Am J Obstet Gynecol 173:1231 Hillier S 1988 N Engl J Med 319: 972 04/03/09
Managing asymptomatic BV infection in pregnant women 19
Some studies show that treatment of pregnant women with BV, who have a history of preterm delivery (high risk), might reduce the risk for prematurity •Screening and treating in pregnancy − might be beneficial for asymptomatic, high risk women − should be conducted at the earliest part of the 2nd trimester to be of benefit
04/03/09
20
04/03/09
BV and HIV 21
Evidence that BV and HIV are related • Theoretical basis • Epidemiological observations • Therapeutic intervention studies
04/03/09
Theoretical 22 basis BV characterised by: – absence of Lactobacilli – low H2O2 – high pH Conditions believed to be conducive to increased susceptibility to HIV infection
04/03/09
Table 2. Mechanisms by which gynecologic 23 infections enhance transmission of human immunodeficiency virus. Loss of protective H2O2-positive lactobacilli Disruption of normal epithelial barrier (portal of entry) Recruitment of susceptible cells Stimulation of susceptible cells Enhanced HIV replication Lesions and/or disease are a source or point of infection of HIV
04/03/09
Epidemiological Observations 24
Epidemiological association found in cross-sectional and prospective studies • Relationship is dose-dependent – severe BV is associated with increasing risk of HIV infection – relative risk of HIV acquisition = 2 to 4
Cohen et al. AIDS 1995; Sewankambo et al. Lancet 1997; Taha et al. AIDS 1998; Martin et al. JID 1999.
04/03/09
Association between BV and HIV acquisition? 25 • 4718 women 15-59 years • Nugent criteria for diagnosis of BV HIV: 14.2 % in women with normal flora 26.7 % in women with severe BV (Nugent 9-10)p < 0.001
Community study in Rakai, Uganda Sewankambo, N Lancet 1997 350: 546a
04/03/09
Table I: Distribution as per Laboratory Diagnosis 26
Department of Community Medicine, M.K.C.G. Medical College, Brahmapur
04/03/09
Table II: Distribution as per Clinical diagnosis
27
Department of Community Medicine, M.K.C.G. Medical College, Brahmapur
04/03/09
Table III --Prevalence of various RTIs among married (non-pregnant) women aged 16– 22 in 13 villages in Vellore District of Tamil Nadu, south India (N = 451).
28
04/03/09
Table 2. Possible factors affecting prevalence of RTIs in young women
29
04/03/09
30
Reference: Gynaecological problems among young married women in Tamil Nadu, India Abraham Joseph, Jasmin Prasad and Sulochana Abraham
04/03/09
Vaginal and iatrogenic infections 31
Vaginal infections • are most common cause of RTIs in women • are associated with adverse outcomes of pregnancy • are associated with increased susceptibility to HIV infection • are associated with high health-care costs to individual women and to health-care system • due to iatrogenic infections, contribute heavily to burden of maternal morbidity and mortality (true magnitude unknown)
04/03/09
32
04/03/09
33
Prevalence of bacterial vaginosis among women in Delhi, India P. Bhalla, Rohit Chawla, S. Garg*, M.M. Singh*, U. Raina**, Ruchira Bhalla & Pushpa Sodhani† Departments of Microbiology, *Community Medicine, **Obstetrics & Gynaecology Maulana Azad Medical College & associated LN Hospital, New Delhi &
04/03/09
Background & objectives:34Bacterial vaginosis is the most common cause of vaginal discharge among women in reproductive age. Surveillance studies on bacterial vaginosis are mostly based on specialist clinic settings. As few population-based prevalence surveys of bacterial vaginosis have been conducted, we studied the prevalence of bacterial vaginosis in the urban and rural communities in Delhi, and to associate the presence of bacterial vaginosis with demoraphic profile, risk factors and presence of other reproductive tract infections (RTIs)/ sexually
04/03/09
35
Results: Bacterial vaginosis was diagnosed in 70 (32.8%) subjects. A high percentage though asymptomatic (31.2%) were found to have bacterial vaginosis. Highest prevalence was seen in urban slum (38.6%) followed by rural (28.8%) and urban middle class community (25.4%). All women with vaginal trichomoniasis were found to have bacterial vaginosis while 50 per cent of subjects having syphilis also had bacterial
04/03/09
36
Interpretation & conclusion: The study showed high prevalence of bacterial vaginosis. The asymptomatic women having bacterial vaginosis are less likely to seek treatment for the morbidity and thus are more likely to acquire other STIs. Women attending various healthcare facilities should be screened and treated for bacterial vaginosis to reduce the risk of
04/03/09
The maturation of the acquired immunodeficiency syndrome epidemic has now claimed 37 worldwide, the majority in more than 12 million women undeveloped countries where human immunodeficiency virus (HIV) and sexually transmitted infections coexist and interact synergistically. Among HIV-infected women, there is excessive morbidity due to sexually transmitted diseases (STDs) and gynecologic disorders. This review summarizes the expanding understanding of vaginal flora, vaginitis, cervicitis, pelvic inflammatory disease, and genital ulcer disease in HIV-infected women. In addition to the altered clinical course, complications, and management difficulties of STDs, some gynecologic infections may influence HIV transmission as well as the vertical transmission of HIV to the newborn. Finally, severe immunodeficiency allows unusual opportunistic pathogens to invade the upper and lower genital tract. Control and prevention of gynecologic infections in HIVpositive and HIV-negative women are key components to preventing further HIV transmission. 04/03/09
38
NACO AND ITS ROLE TO FIGHT AGAINST AIDS/HIV
04/03/09
39
04/03/09
40
04/03/09
41
04/03/09
42
STRATEGIC MOVE : PUBLIC PRIVATE PARTNERSHIP: *.TO EXPAND DELIVERY OF PPTCT *.PARTNERSHIP WITH FOGSY TO COVER 10 MILLION PREGNANT WOMEN ON ACTUAL COST BASIS
04/03/09
43
No of Estimated pregnancy in India: 27 million No. of HIV Infected Mothers: 1,89,000 No. of Infected Babies : 56,700 (Vertical Transmission of Infection.)
04/03/09
COVERAGE OF NACO
44
NO OF MEDICAL COLLEGES : > 200 NO OF DISTRICT HOSPITALS: > 500 AVG. PATIENT OPD IN MOTHER AND CHILD CARE : 200 PATIENTS/WEEK CHILD BEARING CASES (20% OF TOTAL) : 40 CASES/WEEK 1ST TRIMESTER OR 28-31 WEEK PREGNANCY: 50% 20 CASES/WEEK
04/03/09
PER YEAR PER HOSPITAL : N45x 4 x 12 N=20 FOR MEDICAL COLLEGE N1=10 FOR DISTRICT HOSPITAL NO OF CASES PER MEDICAL COLLEGE PER YEAR= 960 TOTAL NO OF CASES IN MEDICAL COLLEGES: 960 X 200 = 192000 CASES PER YEAR NO OF CASES PER DISTRICT HOSPITAL PER YEAR = 480 TOTAL NO OF CASES IN DISTRICT HOSPITALS: 480 X 500 = 240000
04/03/09
46
TOTAL NO OF CASES TO BE COVERED TOTAL NO OF CASES IN MED COL. + TOTAL NO OF CASES IN DIST. HOSP 1920000 + 240000 = 4320000 CASES TO BE DIAGNOSED FOR BACTERIAL VAGINOSIS : 432000 CASES TO BE DIAGNOSED FOR TRICHOMONIASIS : 432000
04/03/09
47
RATES: BV BLUE : 250/- PER TEST T V TEST: 325/- PER TEST
04/03/09
48
TOTAL COST INCUR FOR BV BLUE : 11 CRORE TOTAL COST INCUR FOR TV TEST : 14 CRORE TOTAL PROJECT COST : 25 CRORE
04/03/09
49
04/03/09
50
BV BLUE TEST
TRICHOMONAS RAPID TEST
1. Rapid test : conducted in 10
1. . Rapid test : conducted in 10
minutes. 2. High Sensitivity and Specificity with more than 95% NPV and PPV 3.As accurate as gram staining and smear US FDA approved Cost effective and convinient to use
minutes. Dipistick method-single reagent. 2. 83% sensitivity vs. culture and 95% agreement against composite reference 3. US FDA approved 4. Cost effective and convinient to use
04/03/09
51
04/03/09
52
04/03/09
53
04/03/09
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